This paper is in the following e-collection/theme issue:

RCTs - Pilots/Feasibility Studies (eHealth) (122) Supporting Partners and Informal Caregivers of Cancer Patients (59) Emotional, Social, Psychological Support for Cancer (270) Participatory Cancer Care (121) Health Services Research in Oncology (66) Formative Evaluation of Non-Ehealth Innovations (215)

Published on in Vol 15 (2026)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/81948, first published .
A Supportive Group Intervention for Caregivers to Patients Diagnosed With Glioblastoma: Protocol for the SUGRI Study

A Supportive Group Intervention for Caregivers to Patients Diagnosed With Glioblastoma: Protocol for the SUGRI Study

A Supportive Group Intervention for Caregivers to Patients Diagnosed With Glioblastoma: Protocol for the SUGRI Study

Authors of this article:

Sara Nordentoft1 Author Orcid Image ;   Rikke Guldager2 Author Orcid Image ;   Helle Pappot3 Author Orcid Image ;   Tiit Mathiesen4 Author Orcid Image ;   Anders Tolver5 Author Orcid Image ;   Karin Piil6, 7 Author Orcid Image
Article Authors Cited by Tweetations (3) Metrics

    Protocol

    1Copenhagen University Hospital, Copenhagen, Denmark and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Copenhagen Ø, Denmark

    2Copenhagen University Hospital, Copenhagen, Denmark. Dept. of People and Technology, Roskilde University, Roskilde, Denmark, Copenhagen University Hospital, Denmark

    3Copenhagen University Hospital and University of Copenhagen, Copenhagen, Denmark and Department of clinical medicine, University of Copenhagen, Copenhagen, Denmark, copenhagen, Denmark

    4Department of Neurosurgery, Copenhagen University Hospital; Department of clinical medicine, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden, Copenhagen Ø, Denmark

    5Statistics and Data Analysis, Danish Cancer Instititute, Danish Cancer Institute, Copenhagen, Denmark, Copenhagen Ø, Denmark

    6Copenhagen University Hospital, Copenhagen and Department of clinical medicine, University of Copenhagen, Denmark, Copenhagen, Denmark

    7Curtin University, Perth, Western Australia, Australia

    Corresponding Author:

    Sara Nordentoft, RN, MHSc

    Copenhagen University Hospital, Copenhagen, Denmark and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

    Inge Lehmanns Vej 8, 2100

    Copenhagen

    Copenhagen Ø, 2100

    Denmark

    Phone: 45 29866734

    Email: sara.marie.juel.nordentoft@regionh.dk


    Background: Caregivers to a person diagnosed with a glioblastoma often face significant responsibilities, balancing the demands of care with the complexities of the disease and treatment trajectory, while also coping with concerns and uncertainty of the future. Caregivers report unmet needs of information and support throughout the patient’s disease and treatment trajectory, and they may benefit from targeted supportive care interventions.

    Objective: The aim of this study is to develop, test, and evaluate the feasibility of a supportive group intervention among caregivers to patients diagnosed with a glioblastoma.

    Methods: The study consists of 3 phases with ongoing patient and public involvement (PPI). In the first phase, a systematic review will be carried out exploring the outcome of supportive group interventions for caregivers to patients diagnosed with a primary brain tumor. In the second phase, the design and development of the intervention will be conducted in cooperation with a panel of caregivers using PPI process. The third phase will include the feasibility and evaluation of the intervention. The study will be guided by the British Medical Research Council’s framework for developing complex interventions. The feasibility of the intervention will be tested in reference to relevant parameters. Quantitative data in terms of questionnaires will be analyzed using descriptive statistics, and qualitative evaluation interviews will be analyzed using thematic analysis.

    Results: A national panel of caregivers (N=10) has been established, and the final design of the intervention is currently developed through an ongoing PPI process. A total of 3 hospitals in Denmark have committed to participating in the recruitment for the feasibility study. Recruitment began in April 2025, and the SUGRI (Supportive Group Intervention for caregivers to patients diagnosed with a glioblastoma) intervention will undergo a feasibility assessment in a multicenter study starting in August 2025, with the final evaluation planned for April 2026.

    Conclusions: This study is expected to provide necessary insights to guide caregiver initiatives, ultimately improving support for caregivers within the neuro-oncology field. A supportive group intervention offered to the caregivers has the potential to address specific caregiver needs and strengthen their supportive network. Providing caregivers with support may enhance their perceived support, strengthen family functioning, and provide them with strategies to manage caregiving challenges, ultimately benefiting both caregivers and patients.

    Trial Registration: ClinicalTrials.gov NCT06869577; https://clinicaltrials.gov/study/NCT06869577

    International Registered Report Identifier (IRRID): PRR1-10.2196/81948

    JMIR Res Protoc 2026;15:e81948

    doi:10.2196/81948

    Keywords

    caregiver; glioblastoma; group intervention; high-grade glioma; neuro-oncology; supportive care 


    Primary malignant brain tumors are among the most fatal cancers and have an international incidence rate of 6.89 per 100,000, compared with 7.03 per 100,000 in Denmark [1,2]. The most common malignant brain tumor is a glioblastoma (GBM), accounting for 51.5% of all malignant brain tumors. It is associated with a poor prognosis: a 5-year relative survival rate of 5% [1]. The typical disease trajectory of 12 to 15 months includes initial surgical intervention (resection or biopsy), followed by a 9- to 10-month standard treatment plan consisting of concomitant chemotherapy or radiation therapy, with subsequent adjuvant chemotherapy of temozolomide [3]. Despite aggressive treatment, tumor progression occurs almost inevitably [4].

    The diagnosis of a GBM is usually preceded by symptoms such as an epileptic seizure, focal neurological deficits, or cognitive changes that may affect the patient’s functional status [2]. Patients often develop a complex symptom burden, including physical symptoms such as aphasia and hemiparesis and psychological symptoms such as cognitive deficits, anxiety, distress, and depression. The symptoms may change as tumor progresses [5-7]. The combination of a rapid onset of the disease, the intense disease and treatment trajectories, and the uncertainty of the future affect not only the individual but also those close to them who function as informal caregivers, a role that often demands great caring responsibilities [8,9]. The caregiver burden is described as multidimensional with components affecting caregivers physically, emotionally, socially, and economically [10]. Caregivers express being unprepared for the new role and report symptoms of anxiety and depression [4,9]. Additionally, social isolation is often a consequence of the caregiver role. Furthermore, the invisibility of the patients’ symptoms can lead to withdrawal of support from family and previous networks [4,11]. Caregivers emphasize the importance of meeting other caregivers in similar situations so that they can share experiences and recognize emotions or concerns in a peer-to-peer environment [12,13]. Peer support may represent an important access to information, advice, and practical help for caregivers and address caregivers’ individual needs of support [12,14,15]. It is often a struggle for caregivers to be separated from the patient, as they worry about risk of seizures or cognitive symptoms that necessitate constant supervision, a struggle that can be alleviated with support [16]. Online access to peer support and information may be valuable for caregivers. Such a tool is accessible and has the potential to ensure broad reach while remaining scalable at the national level. Moreover, online support aligns well with the recommendations of the International Council of Nurses, which indicate that digital health can address population needs, strengthen health systems, and remain feasible despite shortages in the health workforce [17].

    Several authors address the lack of longitudinal studies and advocate for ongoing supportive interventions to target caregivers of patients diagnosed with a brain tumor [10,18,19]. A need of such interventions is further echoed in international research agendas [20,21]. A systematic review from 2021 concluded feasibility of interventions for people with a brain tumor and their caregivers [14]. Importantly, support groups exclusively for caregivers may fulfill their need for peer support [14,22]. Therefore, this study aims to develop, test, and evaluate the feasibility of a supportive group intervention among caregivers to patients diagnosed with a GBM.


    Study Design

    This study titled SUGRI (Supportive Group Intervention for caregivers to patients diagnosed with a glioblastoma) is a 3-phase study. The overall framework is guided by the British Medical Research Council (MRC) framework for developing complex intervention. This methodological framework entails 4 main phases of intervention research: development or identification of the intervention, feasibility, evaluation, and implementation. In this study, we develop, test, and evaluate the feasibility of an intervention; therefore, we are primarily guided by the first 2 phases of the MRC framework: the development phase and the feasibility phase [23-25]. The phases of the MRC framework applied to the SUGRI study are presented in Figure 1. An overview of the intervention logic, including planned activities and expected outcomes, is presented in Figure 2. A patient and public involvement (PPI) plan will be carried out throughout all phases of the SUGRI study, guided by the workbook to guide the development of a Patient Engagement in Research plan [26]. The recommended checklist for research protocols, SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), has been applied (Multimedia Appendix 1) [27].

    ‎
    Figure 1. Complex intervention for the SUGRI (Supportive Group Intervention for caregivers to patients diagnosed with a glioblastoma) study. Solid lines represent this study’s activities; dashed lines represent planned future activities. HCP: health care professional.
    ‎
    Figure 2. Logic model. Solid lines represent planned work; dashed lines represent intended results. HCP: health care professional; PEIR: Patient Engagement in Research; PPI: patient and public involvement; REDCap: Research Electronic Data Capture; SUGRI: Supportive Group Intervention for caregivers to patients diagnosed with a glioblastoma.

    Study Population and Eligibility Criteria

    The term “caregivers” is in this study defined according to the criteria provided by The National Cancer Institute [28]: “Informal caregiving is broadly defined as services provided by an unpaid person, such as helping with personal needs and household chores, managing a person’s finances, arranging for outside services, or visiting regularly. An informal caregiver is usually a relative or friend who may or may not live in the same household as the person with cancer who requires care.” Inclusion criteria are family caregivers (aged ≥18 years) to patients (aged ≥18 years) diagnosed with a GBM grade 4 or diffuse astrocytoma grade 4 receiving chemoradiotherapy treatment. Despite differential terminology of GBM grade 4 and diffuse astrocytoma grade 4 since 2021 [29], the study will include both categories of grade 4 tumors; both are referred to as “GMB” in the protocol. Participants must be able to understand, read, and speak Danish.

    Recruitment Procedure

    Participants will be recruited from the Department of Neuro-oncology at Copenhagen University Hospital in Denmark. The feasibility of the intervention is planned to be evaluated nationally, and the 3 other departments of neuro-oncology in Denmark at Odense University Hospital, Aarhus University Hospital, and Aalborg University Hospital will be invited to participate in the recruitment procedure. A purposive sampling strategy will be applied, and participants will be recruited face-to-face.

    Study Phases

    Exploratory Phase

    A systematic review will identify and explore available evidence of outcomes of supportive group interventions for caregivers to patients diagnosed with a primary brain tumor. To define the group element of an intervention, we decided to include “any kind of intervention, that sought to facilitate some element of interaction between a minimum of two caregivers.” The search will be conducted in the following databases: PubMed, Embase, Web of Science, Emcare, Cochrane Library, and PsycInfo. Peer-reviewed studies in English, German, or Scandinavian will be included without any time limits. The software program Covidence (Veritas Health Innovation Ltd) will support the process of screening [30]. Guidance on the conduct of narrative synthesis in systematic reviews will be used to interpret findings [31]. To address the quality of the included studies, the Mixed Methods Appraisal Tool will be applied [32]. To ensure transparency, the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline will be used [33].

    Development Phase

    According to the MRC framework, the development phase focuses on designing the intervention based on existing evidence and relevant theories, engaging stakeholders, and refining the intervention to ensure contextual fit and relevance to the target population [25]. Therefore, the development of the SUGRI intervention will be grounded in existing evidence from the neuro-oncology field, informed by the findings from the systematic review, and be carried out in close collaboration with stakeholders.

    PPI Activities

    PPI will be central in the development phase, where a national panel of current and bereaved caregivers to patients with a GBM will be established. A panel consisting of 6 to 12 members will allow for deeper interaction and a more trusting environment. Members will be recruited nationally through the Danish Brain Tumor Association. The intervention will be developed and designed in collaboration with a panel of caregivers, using Microsoft Teams as the meeting platform. Online meetings will be scheduled for every second month, and 1 cocreative workshop requiring physical attendance will be planned and facilitated in cooperation with the Danish Knowledge Center for User Involvement in Health Care. The PPI process will be evaluated through a focus group interview with the panel members, guided by the approach described by Krueger and Casey [34]. For the quantitative evaluation, the 22-item Patient Engagement in Research Scale will be used to measure the level of meaningful caregiver engagement in the research process [35,36].

    Intervention

    The intervention will be conducted online and will encompass 2 primary components: an informational element and a group-based element. The final design of the intervention and how the 2 central elements will be incorporated will be developed through an iterative PPI process in cooperation with the panel to integrate existing evidence on caregivers’ needs and preferences. Results from the systematic review from the exploratory phase will also guide the design of the final intervention. The group element will be designed and inspired by existing knowledge of caregiver preferences of supportive group interventions [11,22].

    Feasibility and Evaluation Phase

    The feasibility phase in the MRC framework includes assessment of the feasibility and acceptability of the intervention. It also involves evaluation of the design and the predefined feasibility parameters, addressing uncertainties identified during development, refining the intervention, and considering practical and economic aspects [25]. In the third study phase, the online intervention will be tested on a new group of caregivers, and feasibility will be analyzed and evaluated by integration of qualitative and quantitative methods. A sample size of approximately 30 participants is recommended for feasibility trials [37].

    Primary Objective and End Points

    We hypothesize that offering caregivers a supportive group intervention will empower them in their role by boosting their perceived support, strengthening their family function, and helping them to identify strategies to navigate the challenges of caregiving, ultimately benefiting both caregivers and patients.

    The primary objective of this study is to evaluate the feasibility of the SUGRI intervention. The following parameters will be evaluated: recruitment, fidelity, adherence, acceptability, and safety (detailed in Table 1).

    Table 1. Progression criteria and feasibility parameters.
    Study phaseStudyAim and primary assessmentData collection or assessment methodProgression criteria or predefined benchmarks
    Exploratory phaseSystematic review
    • Aim: to identify and explore available evidence of outcome of supportive group interventions for caregivers to patients with a primary brain tumor
    • Primary assessment: evidence from peer-reviewed literature
    • Data synthesis: guidance on the conduct of narrative synthesis in systematic reviews [31]
    • Quality assessment: the Mixed Methods Appraisal Tool [32]
    • PRISMAa guidelines [33]
    • Proceed to the development phase if:
    • Review confirms a gap for group interventions of the target population
    • Intervention already exists, reconsider scope or adapt intervention
    • Review identifies sufficient evidence to inform group interventions to be positively evaluated
    Development phasePPIb study
    • Aim: to involve caregivers in the design and development of a supportive group intervention targeted at caregivers to patients diagnosed with a glioblastoma and evaluate the PPI process
    • Primary assessment: caregivers’ experiences and perceived meaningful impact of participation
    • Qualitative data: focus group interview guidelines by Krueger and Casey [34]
    • Quantitative data: 22-item Patient Engagement in Research Scale [35,36]
    • Proceed to feasibility and evaluation phase if:
    • A caregiver panel can be successfully established
    • Intervention can be realistically developed in cooperation with the panel, integrating evidence and caregiver input
    Feasibility and evaluation phaseFeasibility study
    • Aim: to test the feasibility of a supportive group intervention among caregivers to patients diagnosed with a glioblastoma
    • Primary assessment: predefined feasibility parameters:
    • Recruitment: is it feasible to recruit participants to the intervention?
    • Fidelity: is the intervention provided as designed?
    • Adherence: how feasible is it to ensure participants adhere to the intervention?
    • Acceptability: what are the experiences and ratings of satisfaction with the intervention?
    • Safety: is the intervention safe for participants?
    • Qualitative data: semistructured individual interviews with caregivers
    • Quantitative data: patient- and caregiver-reported outcome
    • Quantitative registration of recruitment rate
    • Participants are offered the intervention
    • Quantitative registration of intervention participation and participant feedback via study-specific questionnaires and interviews
    • Participant feedback via study-specific questionnaires and interviews
    • Adverse events from validated questionnaires and interviews
    • Proceed to development of a stepped care model if:
    • All 5 feasibility parameters meet their predefined benchmarks
    • Estimated recruitment ≥60%c
    • Estimated fidelity 100%c
    • Estimated adherence ≥70%c
    • Estimated acceptability mean ≥4d
    • Safety reported narrativelye

    aPRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

    bPPI: patient and public involvement.

    cRecruitment rate, fidelity, and adherence are presented as estimates informed by other caregiver interventions and reported as percentages.

    dAcceptability is defined as an average score of ≥4 on a 5-point Likert scale in a study-specific questionnaire. The questionnaire includes the item: “Overall, I found the caregiver program to be supportive,” rated from 1=not at all to 5=to a very great extent.

    eSafety will be reported narratively based on individual postintervention evaluation interviews with caregivers, guided by the following question: “Have you experienced any concerns as a result of your participation that you did not have before?”

    The proposed benchmarks for the 5 feasibility parameters have been guided by existing literature on caregiver interventions [38-41]. Predefined progression criteria, as proposed by the MRC framework, will be assessed through a feasibility study aligned with the evaluation design [24]. Moreover, progression criteria are used to guide the decision on whether to proceed to the next phase of the project [25]. Progression criteria for the 3 study phases—the exploratory phase, the development phase, and the feasibility and evaluation phase—are also presented in Table 1.

    Measurements

    Secondary outcomes are patient-reported outcome data completed by caregivers and patients at baseline, postintervention, and follow-up (Table 1). Caregivers will complete the following 3 questionnaires: the Caregiver Roles and Responsibilities Scale to assess broad life impacts for caregivers [42], the Iceland-Family Perceived Support Questionnaire to measure families’ perceived support from nurses and other health care professionals [43], and the Hospital Anxiety and Depression Scale to measure symptoms of anxiety and depression [44]. Patients will complete the following 3 questionnaires: the Functional Assessment of Cancer Therapy-Brain to assess the patients’ health-related quality of life [45]; the MD Anderson Symptom Inventory-Brain Tumor Module to measure patients’ symptom prevalence, intensity, and interference with the daily life [46]; and Hospital Anxiety and Depression Scale [44]. The questionnaires and time assessment are presented in Table 2 and will be collected electronically using Research Electronic Data Capture (REDCap; Vanderbilt University). Demographic data of the participants will be completed at baseline, and information on patient histology will be obtained from the patient’s medical journal and stored in REDCap.

    Table 2. Measurement tools and assessment time points for the feasibility study.
    Outcome measurement toolsCaregiverPatient

    		T0aT1bT2cT0T1T2
    Quantitative

    		Informed consent✓d

    		✓


    		Demographic data✓

    		✓


    		CRRSe 41 items (0-164 points)✓✓✓



    		ICE-FPSQf 14 items (14-70 points)✓✓✓



    		HADSg 14 items (0-21 points)✓✓✓✓✓✓

    		FACT-Brh 50 items (0-200 points)


    		✓✓✓

    		MDASI-BTi 13 core cancer-related symptoms and 9 brain tumor–specific symptoms (0-220 points)


    		✓✓✓
    Qualitative

    		Semistructured interview
    		✓



    aT0: baseline.

    bT1: postintervention week 12.

    cT2: follow-up week 18.

    dTime points for data collection.

    eCRRS: Caregiver Roles and Responsibilities Scale.

    fICE-FPSQ: Iceland-Family Perceived Support Questionnaire.

    gHADS: Hospital Anxiety and Depression Scale.

    hFACT-Br: Functional Assessment of Cancer Therapy-Brain.

    iMDASI-BT: MD Anderson Symptom Inventory-Brain Tumor Module.

    To explore experiences and evaluate the intervention qualitatively, semistructured individual interviews will be carried out with the participating caregivers postintervention. A semistructured interview guide will be applied, and data will be audiotaped and verbatim transcribed.

    Statistical Analysis

    Results regarding the feasibility of the intervention and the attainment of predefined feasibility parameters will be presented separately. Feasibility parameters and secondary outcomes, including subscale scores from patient-reported outcomes, will be presented using descriptive statistics. Mean change from baseline to later assessment times will be analyzed using appropriate statistical methods, possibly a linear mixed model to account for repeated measurements on each participant. This will further ensure that no imputation is required to handle missing data under the missing-at-random assumption. No formal adjustment of P values to control the number of false positives will be used, as analyses of secondary outcomes should be regarded as exploratory. Patient-reported outcome data will provide valuable insight into the impact of the caring responsibilities, perceived support, and the caregiver role combined with the patient’s well-being, with a particular emphasis on their emotional and functional challenges.

    Qualitative Analysis

    Qualitative interview data will be analyzed using thematic analysis, as described by Braun and Clarke [47,48], using the NVivo software (Lumivero) [49]. The interview data will provide the opportunity to evaluate specific elements of the intervention, contributing to a more comprehensive understanding of how different aspects of the intervention impact caregivers. The qualitative and quantitative data will be collected and analyzed separately and then merged. In the overall interpretation, the 2 datasets will be compared, and we will search for potential common patterns [50-52].

    Ethical Considerations

    The study adheres to the ethical standards of the institutional and national research committee and complies with the Declaration of Helsinki. The study was approved by the ethical committee of the Capital Region of Denmark (F‑24004933) and registered with the Danish Data Protection Agency (Jr. P‑2022‑739). No compensation is provided for participation. Potential ethical risks include breaches of privacy or integrity, while other types of harm are considered unlikely. Study participants as well as future patients and caregivers may benefit from the study. Measures will be taken to protect integrity. Participants will be enrolled based on oral and written informed consent, which can be withdrawn at any time. All participants will provide written informed consent before enrollment and will be informed about procedures related to confidentiality, safeguarding, and support throughout the intervention. Clear rules for confidentiality will be established at the beginning of the online group sessions, including reminders to not share identifiable information outside the group. To ensure participant well-being, facilitators will be attentive to recognizing signs of emotional distress during the sessions. If a participant appears overwhelmed, they will be offered a one-on-one follow-up conversation and, if necessary, referred to appropriate support services.

    Study Registration

    The study is registered on ClinicalTrials.gov (NCT06869577), and the systematic review is registered in PROSPERO (CRD42023392222).


    A national panel of caregivers (N=10) has been successfully established, and the final design of the intervention is currently being developed through an ongoing PPI process. A total of 3 hospitals in Denmark have committed to participating in the recruitment for the feasibility study. Recruitment began in April 2025. The multicenter feasibility assessment of the SUGRI intervention is scheduled to start in autumn 2025, and the final evaluation is planned for spring 2026


    Positioning Supportive Caregiver Care Within the Neuro‑Oncology Landscape

    Caregiver support within the neuro-oncology field remains suboptimal. This paper describes a study protocol for a supportive group intervention for caregivers to patients diagnosed with a GBM. The intervention is designed to address the challenges faced by caregivers, with particular emphasis on their need for information and peer support. We expect that participation in a group intervention will empower caregivers by enhancing their perceived social support, strengthening family functioning, and helping them identify strategies to navigate caregiving challenges—ultimately benefiting both caregivers and patients.

    Caregivers may benefit from continuous access to support throughout the patient’s treatment trajectory, tailored to address the specific emotional challenges and stressors that caregivers face in their role as a caregiver [53]. Previous interventions have been carried out using a dyadic approach, where patients and caregivers receive the intervention together, allowing for mutual support [54,55]. However, Mulbury et al [56] examined preferences for intervention delivery, comparing a dyadic format, involving both patient and caregiver, with a caregiver-only format and found that the caregiver-only approach was significantly more beneficial for caregivers. This supports the findings of Mallya et al [22], who reported a clear preference among caregivers for dedicated support groups separate from those involving the patient. Group-based interventions offer caregivers a chance to connect with others in similar situations, creating a safe and supportive environment for sharing emotions, concerns, and experiences [13,22]. Peer support may also provide valuable practical advice, help normalize experiences, and offer new perspectives on personal caregiving experiences [13,14]. Group-based interventions may also offer validation, a sense of belonging, and foster hope [4].

    Given the diverse nature of caregiver needs, shaped by demographic, course of the disease, and patient symptom burden, future research may benefit from moving beyond standardized approaches and explore the potential of multicomponent interventions [14,22]. Therefore, the MRC framework may provide an overall structured framework designed to guide this study. An intervention may be described as complex when it includes multiple components interacting with each other and allows for flexibility or tailoring [25]. The SUGRI intervention is planned to include 2 primary components: an informational element and a group-based element. Integration of these 2 components will be developed through a PPI process.

    The updated MRC framework from 2021 includes 6 core elements to be addressed throughout the research process, one of which is engaging stakeholders [24]. Engagement of the stakeholders meaningfully at every stage of the research process is essential to develop interventions that positively impact health outcomes for patients and caregivers [24]. In the SUGRI project, we plan to establish a PPI collaboration with a panel of current and bereaved caregivers throughout the project. The MRC framework recommends involving stakeholders early in the research process [25]; however, out of respect for the caregivers’ time, we have chosen not to include them at the very beginning during the protocol stage. The protocol, while serving as the foundation for the project, is intentionally described in broad terms, as the detailed design of the intervention will be developed collaboratively with the caregiver panel. Given the poor prognosis of a GBM, we anticipate the panel to be dynamic, with caregivers leaving as patients enter end-of-life phases and new caregivers are invited to join. Most of the panel activities are scheduled to be online, as caregivers may have practical difficulties to schedule physical meetings due to their caregiver role.

    The feasibility test of the SUGRI intervention aims to address caregivers’ supportive needs throughout the patient’s disease and treatment trajectory. Moreover, we anticipate the SUGRI intervention to inform how a tailored intervention can be both feasible and meaningful within the context of caregivers’ daily lives.

    Strengths and Limitations

    A major strength of the project is that it addresses an evident and urgent need for support among caregivers of patients with GBM, a need that has also been expressed by clinicians seeking structured ways to assist caregivers in navigating this profoundly life-changing situation. A limitation of this protocol is that the intervention has not yet been fully developed. Consequently, there is uncertainty regarding its specific content, structure, and timing, which will determine the feasibility and overall evaluation of the intervention.

    The study incorporates PPI, which represents a methodological strength by ensuring the intervention is tailored to the target population and enhances its relevance and acceptability. The project also includes an evaluation of the PPI process itself, thereby contributing to the validation of the intervention from the perspective of the involved caregivers.

    The guidance of the MRC framework is another strength, as it provides a structured and evidence-informed approach to intervention development. It supports transparency, theoretical grounding, and relevance to the target population, thereby enhancing the quality and potential impact of the final intervention.

    Future Directions

    Health care resources should be used in an efficient manner to ensure the greatest impact. At the same time, it is essential that support efforts are tailored to the individual needs, particularly in light of the evolving shortages in the health workforce [17]. Moreover, caregiver support is likely to be cost-effective, providing societal benefits by improving health outcomes. Cost-benefit of caregiver intervention is not part of this protocol but would be interesting to evaluate.

    Stepped care is a health care delivery model that allocates resources efficiently by matching the level of care to the individual’s needs [57,58]. Depending on the design of the SUGRI intervention, a stepped care model may be beneficial for the future direction of the study. In a stepped care approach, the intensity of support provided to caregivers can be adjusted according to their individual needs and preferences, ensuring that they receive appropriate and timely support. Applying a stepped care model to future caregiver interventions may enhance their adaptability to hospital workflows and better address the individual needs of caregivers.

    Dissemination Plan

    Dissemination of results includes publication of articles in peer-reviewed journals: a systematic review, a PPI article, and an article on the feasibility of the intervention. Moreover, results will be presented at scientific conferences, to clinicians within the neuro-oncology field, and to the panel of caregivers who participated in the PPI process.

    Conclusions

    The SUGRI study will develop, test, and evaluate the feasibility of a supportive group intervention. The intervention has the potential to address specific caregiver needs and strengthen their supportive network by offering a supportive group intervention to the caregivers. Only few group interventions targeting the neuro-oncology caregiver have been carried out, and results may contribute with new internationally relevant knowledge to improve conditions and care for patients with GBM and their caregivers. Providing caregivers with support may enhance their perceived support, strengthen family functioning, and provide them with strategies to manage caregiving challenges, ultimately benefiting both caregivers and patients.

    Clinical Implications

    Family members of patients diagnosed with a GBM often assume caregiver roles and take on a great responsibility. The SUGRI study accepts this fact and assumes caregivers not only not only need support but also represent an untapped resource. An online intervention may enhance support for caregivers, offering flexibility and helping to reduce the demand on clinical staff. This approach underscores the need for labor-saving technologies to address the nursing shortage and improve patient care [17]. To the best of our knowledge, a group intervention has not yet been systematically offered to caregivers of patients with a GBM in a Danish context, making its feasibility and outcomes of significant interest to the field of neuro-oncological caregiver research.

    Acknowledgments

    The authors would like to acknowledge the caregiver panel for their valuable cooperation in the SUGRI (Supportive Group Intervention for caregivers to patients diagnosed with a glioblastoma) project. Moreover, the authors would like to gratefully acknowledge the established collaboration with the national treatment sites. We used the generative AI tools Microsoft Copilot and ChatGPT for language refinement, including grammar checks and readability improvement. All content was subsequently reviewed and revised by the authors.

    Funding

    This work was supported by the Copenhagen University Hospital, Rigshospitalet (grant E-23565-08); the Danish Cancer Society (grant R344-A19341); and the Novo Nordisk Foundation (grant NNF22OC0080425) and is a part of the Models of Cancer Care research program.

    Authors' Contributions

    Conceptualization and design of the project: SN, KP

    Development of protocol: SN, KP, RG

    Review and feedback on protocol: HP, TM

    Drafting of the manuscript: SN, KP, RG

    Critical revision of the manuscript: all authors

    Final approval of the manuscript: all authors

    Conflicts of Interest

    None declared.

    Multimedia Appendix 1

    SPIRIT 2025 checklist of items to address in a randomized trial protocol.

    PDF File (Adobe PDF File), 293 KB
    1. Price M, Ballard C, Benedetti J, Neff C, Cioffi G, Waite KA, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2017-2021. Neuro Oncol. Oct 06, 2024;26(Supplement_6):vi1-vi85. [CrossRef] [Medline]
    2. Rasmussen BK, Hansen S, Laursen RJ, Kosteljanetz M, Schultz H, Nørgård BM, et al. Epidemiology of glioma: clinical characteristics, symptoms, and predictors of glioma patients grade I-IV in the the Danish Neuro-Oncology Registry. J Neurooncol. Dec 2017;135(3):571-579. [CrossRef] [Medline]
    3. Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. May 2009;10(5):459-466. [CrossRef] [Medline]
    4. Piil K, Laegaard Skovhus S, Tolver A, Jarden M. Neuro-oncological symptoms: a longitudinal quantitative study of family function, perceived support, and caregiver burden. J Fam Nurs. Feb 21, 2022;28(1):43-56. [CrossRef] [Medline]
    5. Molassiotis A, Wilson B, Brunton L, Chaudhary H, Gattamaneni R, McBain C. Symptom experience in patients with primary brain tumours: a longitudinal exploratory study. Eur J Oncol Nurs. Dec 2010;14(5):410-416. [CrossRef] [Medline]
    6. Noll K, King AL, Dirven L, Armstrong TS, Taphoorn MJ, Wefel JS. Neurocognition and health-related quality of life among patients with brain tumors. Hematol Oncol Clin North Am. Feb 2022;36(1):269-282. [CrossRef] [Medline]
    7. Armstrong TS, Dirven L, Arons D, Bates A, Chang SM, Coens C, et al. Glioma patient-reported outcome assessment in clinical care and research: a Response Assessment in Neuro-Oncology collaborative report. Lancet Oncol. Feb 2020;21(2):e97-103. [CrossRef] [Medline]
    8. Schmer C, Ward-Smith P, Latham S, Salacz M. When a family member has a malignant brain tumor: the caregiver perspective. J Neurosci Nurs. Apr 2008;40(2):78-84. [CrossRef] [Medline]
    9. Schubart JR, Kinzie MB, Farace E. Caring for the brain tumor patient: family caregiver burden and unmet needs. Neuro Oncol. Feb 2008;10(1):61-72. [FREE Full text] [CrossRef] [Medline]
    10. Bayen E, Laigle-Donadey F, Prouté M, Hoang-Xuan K, Joël ME, Delattre JY. The multidimensional burden of informal caregivers in primary malignant brain tumor. Support Care Cancer. Jan 13, 2017;25(1):245-253. [CrossRef] [Medline]
    11. Cubis L, Ownsworth T, Pinkham MB, Chambers S. The social trajectory of brain tumor: a qualitative metasynthesis. Disabil Rehabil. Aug 19, 2018;40(16):1857-1869. [CrossRef] [Medline]
    12. Nordentoft S, Dieperink KB, Johansson SD, Jarden M, Piil K. Evaluation of a multimodal rehabilitative palliative care programme for patients with high-grade glioma and their family caregivers. Scand J Caring Sci. Sep 23, 2022;36(3):815-829. [CrossRef] [Medline]
    13. Kanter C, D'Agostino NM, Daniels M, Stone A, Edelstein K. Together and apart: providing psychosocial support for patients and families living with brain tumors. Support Care Cancer. Jan 29, 2014;22(1):43-52. [CrossRef] [Medline]
    14. Heinsch M, Cootes H, Wells H, Tickner C, Wilson J, Sultani G, et al. Supporting friends and family of adults with a primary brain tumour: a systematic review. Health Soc Care Community. May 11, 2022;30(3):869-887. [CrossRef] [Medline]
    15. Au TH, Willis C, Reblin M, Peters KB, Nghiemphu PL, Taylor JW, et al. Caregiver burden by treatment and clinical characteristics of patients with glioblastoma. Support Care Cancer. Feb 11, 2022;30(2):1365-1375. [FREE Full text] [CrossRef] [Medline]
    16. Paterson C, Roberts C, Li J, Chapman M, Strickland K, Johnston N, et al. What are the experiences of supportive care in people affected by brain cancer and their informal caregivers: a qualitative systematic review. J Cancer Surviv. Oct 31, 2024;18(5):1608-1629. [FREE Full text] [CrossRef] [Medline]
    17. The future of nursing and digital health: new ICN position statement highlights opportunities and risks. International Council of Nurses. Sep 1, 2023. URL: https:/​/www.​icn.ch/​news/​future-nursing-and-digital-health-new-icn-position-statement-highlights-opportunities-and [accessed 2026-02-18]
    18. Piil K, Juhler M, Jakobsen J, Jarden M. Controlled rehabilitative and supportive care intervention trials in patients with high-grade gliomas and their caregivers: a systematic review. BMJ Support Palliat Care. Mar 02, 2016;6(1):27-34. [FREE Full text] [CrossRef] [Medline]
    19. Boele FW, Rooney AG, Bulbeck H, Sherwood P. Interventions to help support caregivers of people with a brain or spinal cord tumour. Cochrane Database Syst Rev. Jul 02, 2019;7(7):CD012582. [FREE Full text] [CrossRef] [Medline]
    20. MacDonald L. Top 10 priorities for clinical research in primary brain and spinal cord tumours. Neuro-Oncology Group. Jun 2015. URL: https://www.jla.nihr.ac.uk/media/4826/download [accessed 2026-02-18]
    21. Piil K, Jarden M, Pii KH. Research agenda for life-threatening cancer. Eur J Cancer Care (Engl). Jan 2019;28(1):e12935. [CrossRef] [Medline]
    22. Mallya S, Daniels M, Kanter C, Stone A, Cipolla A, Edelstein K, et al. A qualitative analysis of the benefits and barriers of support groups for patients with brain tumours and their caregivers. Support Care Cancer. Jun 2020;28(6):2659-2667. [CrossRef] [Medline]
    23. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al. Designing and evaluating complex interventions to improve health care. BMJ. Mar 03, 2007;334(7591):455-459. [FREE Full text] [CrossRef] [Medline]
    24. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. Sep 30, 2021;374:n2061. [FREE Full text] [CrossRef] [Medline]
    25. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update. Health Technol Assess. Sep 2021;25(57):1-132. [FREE Full text] [CrossRef] [Medline]
    26. Workbook to guide the development of a Patient Engagement In Research (PEIR) Plan. Arthritis Research Canada. 2018. URL: https://www.arthritisresearch.ca/wp-content/uploads/2018/06/PEIR-Plan-Guide.pdf [accessed 2026-02-18]
    27. Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. Apr 28, 2025;389:e081477. [CrossRef] [Medline]
    28. Informal caregivers in cancer: roles, burden, and support (PDQ®): health professional version. In: PDQ Cancer Information Summaries [Internet]. Bethesda, MD. National Cancer Institute (US); 2002.
    29. Torp SH, Solheim O, Skjulsvik AJ. The WHO 2021 classification of central nervous system tumours: a practical update on what neurosurgeons need to know-a minireview. Acta Neurochir (Wien). Sep 2022;164(9):2453-2464. [FREE Full text] [CrossRef] [Medline]
    30. Covidence. URL: https://www.covidence.org/ [accessed 2026-02-18]
    31. Popay J, Roberts H, Sowden A, Petticrew M, Arai L, Rodgers M, et al. Guidance on the conduct of narrative synthesis in systematic reviews: a product from the ESRC Methods Programme. Lancaster University. Apr 2006. URL: https://tinyurl.com/5cscchr7 [accessed 2026-02-18]
    32. Hong QN, Pluye P, Fàbregues S, Bartlett G, Boardman F, Cargo M, et al. Mixed methods appraisal tool (MMAT) version 2018: user guide. Canadian Intellectual Property Office, Industry Canada. 2018. URL: http:/​/mixedmethodsappraisaltoolpublic.​pbworks.com/​w/​file/​fetch/​127916259/​MMAT_2018_criteria-manual_2018-08-01_ENG.​pdf [accessed 2026-02-18]
    33. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Syst Rev. Mar 29, 2021;10(1):89. [FREE Full text] [CrossRef] [Medline]
    34. Krueger RA, Casey MA. Focus Groups: A Practical Guide for Applied Research. Thousand Oaks, CA. SAGE Publications; 2008.
    35. Hamilton CB, Hoens AM, McQuitty S, McKinnon AM, English K, Backman CL, et al. Development and pre-testing of the Patient Engagement In Research Scale (PEIRS) to assess the quality of engagement from a patient perspective. PLoS One. Nov 1, 2018;13(11):e0206588. [FREE Full text] [CrossRef] [Medline]
    36. Christiansen MG, Pappot H, Hamilton C, Lund-Jacobsen T, Kristensen AW, Nordentoft S, et al. Patient Engagement in Research Scale (PEIRS-22): Danish translation, applicability, and user experiences. Res Involv Engagem. Dec 07, 2023;9(1):115. [FREE Full text] [CrossRef] [Medline]
    37. Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. Aug 20, 2013;13(1):104. [FREE Full text] [CrossRef] [Medline]
    38. Whisenant M, Weathers SP, Li Y, Aldrich E, Ownby K, Thomas J, et al. Simulation-based caregiving skills training for family members of high-grade glioma patients. Neurooncol Pract. Aug 2024;11(4):432-440. [FREE Full text] [CrossRef] [Medline]
    39. Rooney AG, Hewins W, Walker A, Mackinnon M, Withington L, Robson S, et al. Lifestyle coaching is feasible in fatigued brain tumor patients: a phase I/feasibility, multi-center, mixed-methods randomized controlled trial. Neurooncol Pract. Jun 2023;10(3):249-260. [FREE Full text] [CrossRef] [Medline]
    40. Vranceanu AM, Bannon S, Mace R, Lester E, Meyers E, Gates M, et al. Feasibility and efficacy of a resiliency intervention for the prevention of chronic emotional distress among survivor-caregiver dyads admitted to the neuroscience intensive care unit: a randomized clinical trial. JAMA Netw Open. Oct 01, 2020;3(10):e2020807. [FREE Full text] [CrossRef] [Medline]
    41. Halkett GK, Lobb EA, Miller L, Shaw T, Moorin R, Long A, et al. Feasibility testing and refinement of a supportive educational intervention for carers of patients with high-grade glioma - a pilot study. J Cancer Educ. Oct 11, 2018;33(5):967-975. [CrossRef] [Medline]
    42. Shilling V, Starkings R, Jenkins V, Cella D, Fallowfield L. Development and validation of the caregiver roles and responsibilities scale in cancer caregivers. Qual Life Res. Jun 18, 2019;28(6):1655-1668. [FREE Full text] [CrossRef] [Medline]
    43. Sveinbjarnardottir EK, Svavarsdottir EK, Hrafnkelsson B. Psychometric development of the Iceland-Family Perceived Support Questionnaire (ICE-FPSQ). J Fam Nurs. Aug 20, 2012;18(3):328-352. [CrossRef] [Medline]
    44. Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. Aug 01, 2003;1:29. [FREE Full text] [CrossRef] [Medline]
    45. Thavarajah N, Bedard G, Zhang L, Cella D, Beaumont JL, Tsao M, et al. Psychometric validation of the functional assessment of cancer therapy--brain (FACT-Br) for assessing quality of life in patients with brain metastases. Support Care Cancer. Apr 28, 2014;22(4):1017-1028. [CrossRef] [Medline]
    46. Piil K, Whisenant M, Mendoza T, Armstrong T, Cleeland C, Nordentoft S, et al. Psychometric validity and reliability of the Danish version of the MD Anderson Symptom Inventory Brain Tumor Module. Neurooncol Pract. Apr 2021;8(2):137-147. [FREE Full text] [CrossRef] [Medline]
    47. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. Jul 21, 2008;3(2):77-101. [CrossRef]
    48. Braun V, Clarke V. Thematic Analysis: A Practical Guide. Thousand Oaks, CA. SAGE Publications; 2021.
    49. NVivo 11. QSR International. URL: https:/​/download.​qsrinternational.com/​Document/​NVivo11/​11.3.0/​en-US/​NVivo11-Getting-Started-Guide-Pro-edition.​pdf [accessed 2026-02-18]
    50. Guetterman TC, Fetters MD, Creswell JW. Integrating quantitative and qualitative results in health science mixed methods research through joint displays. Ann Fam Med. Nov 09, 2015;13(6):554-561. [FREE Full text] [CrossRef] [Medline]
    51. Creswell JW, Inoue M. A process for conducting mixed methods data analysis. J Gen Fam Med. Jan 03, 2025;26(1):4-11. [CrossRef] [Medline]
    52. Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. Dec 2013;48(6 Pt 2):2134-2156. [FREE Full text] [CrossRef] [Medline]
    53. Clarke JJ, Halkett GK, McDougall E, Dhillon HM, Lobb E, Phillips JL, et al. What do carers of people with high-grade glioma perceive could improve their preparedness to care, and what additional support do they require? Neurooncol Pract. Jun 2024;11(3):296-306. [FREE Full text] [CrossRef] [Medline]
    54. Milbury K, Li J, Weathers SP, Mallaiah S, Armstrong T, Li Y, et al. Pilot randomized, controlled trial of a dyadic yoga program for glioma patients undergoing radiotherapy and their family caregivers. Neurooncol Pract. Jul 2019;6(4):311-320. [FREE Full text] [CrossRef] [Medline]
    55. Ownsworth T, Chambers S, Aitken JF, Foote M, Pinkham MB, Gordon LG, et al. Evaluation of a telehealth psychological support intervention for people with primary brain tumour and their family members: study protocol for a randomised controlled trial. Eur J Cancer Care (Engl). Jul 10, 2019;28(4):e13132. [CrossRef] [Medline]
    56. Milbury K, Whisenant M, Weathers SP, Malliaha S, Snyder S, Jackson N, et al. Dyadic versus individual delivery of a yoga program for family caregivers of glioma patients undergoing radiotherapy: results of a 3-arm randomized controlled trial. Cancer Med. Mar 2023;12(6):7567-7579. [FREE Full text] [CrossRef] [Medline]
    57. Yang P, Zhang L, Tian X. Application of stepped care model in cancer patients: a scoping review. Support Care Cancer. Dec 17, 2024;33(1):34. [CrossRef] [Medline]
    58. Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry. Jan 02, 2005;186(1):11-17. [CrossRef] [Medline]

    ‎
    GBM: glioblastoma
    MRC: Medical Research Council
    PPI: patient and public involvement
    PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses
    REDCap: Research Electronic Data Capture
    SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials
    SUGRI: Supportive Group Intervention for caregivers to patients diagnosed with a glioblastoma

    Edited by J Sarvestan; submitted 06.Aug.2025; peer-reviewed by LPV Bovim; comments to author 09.Oct.2025; revised version received 19.Dec.2025; accepted 22.Dec.2025; published 11.Mar.2026.

    Copyright

    ©Sara Nordentoft, Rikke Guldager, Helle Pappot, Tiit Mathiesen, Anders Tolver, Karin Piil. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.Mar.2026.

    This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.