This is a prospective pilot study exploring the feasibility of digital patient-controlled access to palliative cancer care. It is underpinned by the Framework for Developing and Evaluating Complex Interventions [25] and addresses the research questions with a mixed methods approach [26]. The study’s quantitative strand is based on a single-center, single-arm, pretest and posttest design, and the qualitative strand is based on a descriptive research design. The data will be collected concomitantly from the same sample and analyzed separately before being ultimately combined to broaden the understanding of feasibility aspects [27].

The study will be conducted at the acute palliative care unit (APCU), Cancer Clinic, St. Olavs Hospital, which is a European Society for Medical Oncology (ESMO)–designated center of integrated oncology and palliative care. The hospital has an electronic medical record system, with the integrated MyHealth app allowing mutual communication between health care providers and patients. All patients in the Mid-Norway Health Authority, where St. Olavs Hospital, Trondheim University Hospital, is situated, have access to MyHealth. The app is available in Norwegian only, although additions in other languages are under development.

The APCU consists of an outpatient clinic and a hospital ward located on the same floor. The outpatient clinic conducts approximately 1500 consultations each year. It also serves family physicians and home care services, allows direct contact with patients and relatives, and conducts weekly home visits. The hospital ward has 12 single-bed rooms, about 550 annual admissions, and an average hospital length of stay of 1 week. The unit is staffed with 36 nurses and 7 physicians, of whom 5 are senior oncologists with competency in specialized palliative care and 2 are junior physicians. Additionally, a multidisciplinary team consisting of physiotherapists, chaplains, an occupational therapist, a clinical dietitian, and a social worker is available for both patients and their family members.

Patients with cancer receiving palliative care, regardless of whether they are receiving oncological treatment, are referred to the unit. Patients with lung, gynecologic, and hematological malignancies are cared for by their respective hospital departments. As part of standard care, patients referred to the outpatient clinic are initially contacted by telephone by a designated nurse for information and triage. This is followed by an appointment with a palliative care physician and a nurse. Thereafter, consecutive visits are planned. Patients receiving tumor-directed treatment are followed by both an oncologist responsible for the cancer treatment and a palliative care physician, separately or in joint consultations, while patients receiving palliative care only are followed by a palliative care physician.

We aim to recruit 20 adults with incurable cancer. In the context of a feasibility study, this number is methodologically appropriate and ethically justified [23,28]. No sample size calculations are provided due to the pilot nature of this study. Feasibility studies aim to assess practical aspects, such as recruitment, retention, data collection procedures, and acceptability of the intervention, rather than test hypotheses or estimate treatment effects. According to published guidelines, sample sizes between 12 and 30 participants are considered sufficient to evaluate feasibility outcomes and inform the design of future trials [28]. In the context of palliative care, where patients often experience a high symptom burden and have limited time, a smaller sample minimizes participant burden while still providing meaningful insights into feasibility, compliance, and preliminary outcome trends. This approach ensures ethical sensitivity and aligns with best practices for feasibility research in vulnerable populations.

All patients referred to the APCU will be screened for eligibility at their first or second appointment at the outpatient clinic by 1 of the 2 palliative care physicians involved in the study. Eligible patients will be given brief information about the study and asked if they are willing to receive more information about it. For patients willing to receive further information, the palliative care physician will contact the research nurse, who will come to the outpatient clinic to provide study information and potentially obtain written informed consent. We will also invite the primary carer of all included patients to participate in a postintervention patient-carer dyadic interview. They will be given a separate information letter by the research nurse, who will also obtain consent from those willing to participate in the interview.

Furthermore, all HCPs involved in recruiting patients will be invited to participate in a focus group interview at the end of the study. The rationale for this is to explore the experiences of carers and HCPs to further inform the feasibility and acceptability of the digital on-demand intervention. We anticipate conducting 1 focus group with 6 to 8 participants. Eligibility criteria for study participants are outlined in the next section.

Inclusion criteria for patients are as follows: (1) being referred to the APCU, (2) being diagnosed with locally advanced or metastatic cancer, (3) not receiving oncological follow-up, and (4) being an adult (aged ≥18 years). Exclusion criteria include (1) patients with lung, gynecologic, or hematological malignancies under follow-up by other departments; (2) cognitive impairment preventing informed consent or participation; (3) language barriers preventing study compliance; and (4) currently receiving oncological follow-up.

Inclusion criteria for carers are as follows: (1) being the primary caregiver of a patient included in the study and (2) being willing and able to provide informed consent and participate in the study. Exclusion criteria include (1) medical or cognitive impairment preventing participation and (2) language barriers.

Inclusion criteria for HCPs are as follows: (1) working at the APCU outpatient clinic, (2) being trained in the intervention, and (3) being involved in the recruitment and follow-up of study participants.

The overall goal of the intervention is to provide safe follow-up with preserved patient autonomy and minimal time toxicity. Specifically, the intervention is a digital follow-up app that has been incorporated into MyHealth, which is an integrated part of the hospital’s electronic medical record system. The app facilitates mutual communication between health care providers and patients. The intervention aligns with the Norwegian health care authorities’ strategy for cancer care [29], emphasizing patient-controlled digital access to palliative care follow-up. It is a multilayered intervention, serving 3 purposes.

The first purpose is symptom monitoring. Once weekly, patients will complete an electronic version of the revised Edmonton Symptom Assessment System (ESAS-r) questionnaire [30]. Data will be submitted electronically to the APCU outpatient clinic via MyHealth, enabling HCPs to monitor patients’ symptoms and contact them in case of symptom worsening.

The second purpose is self-management support. Patients will gain access to a designated website offering guidance on symptom self-management and care in general, thus promoting patient autonomy and informed decision-making.

The third purpose is patient-controlled access to care. Patients and family carers can electronically book appointments or request contact with the APCU at a time and setting of their choice. This will ensure access to health care services when needed rather than through prearranged outpatient clinic appointments. Participants will be asked to report their need for contact on a weekly basis. In addition, consistent with current standard procedures, patients and family carers will be encouraged to contact the APCU at any time outside the scheduled weekly assessments if required, using the provided telephone number. Similarly, should the digital system fail or patients experience problems using it, they should contact the APCU immediately.

Health care personnel will monitor messages from patients daily; this applies to weekends and holidays as well. In the event of newly developed high symptom burden for which daily digital follow-up is insufficient, patients or family carers should contact the department directly by telephone. During regular working hours, this ensures immediate contact with a study physician; outside these hours—or at any other time when study physicians are unavailable for any reason—patients will get a consultation with the on-call physician at the cancer clinic. The situation will be managed as an emergency event, following the same procedures used in standard care at the department.

Likewise, HCPs at the APCU may contact patients at any time when medically indicated. Hence, the intervention will offer patients safe follow-up without unnecessary time away from their homes. Patients consenting to the study will be trained in using the intervention components in the MyHealth digital app and invited to use them for 6 weeks.

Criteria for discontinuing the intervention will be admission to the hospital for the remaining time of the intervention or a participant’s unwillingness to continue.

The study was designed in collaboration with, and with input from, the cancer clinic’s user panel for research. A designated user representative, appointed by the Norwegian Cancer Society, played an important part in the development of the intervention and will do so during the remaining work. Specifically, the user representative provided feedback on the concept of the intervention when it was first presented to the user involvement panel. They further provided input on the patient information letter and the protocol for the study. Furthermore, during June 2026 and July 2026, a total of 2 user representatives were involved in prepilot testing of the digital app. They will also have an important role in discussing the results from the feasibility study and planning the next steps in the research.

Data submitted by participants through the MyHealth app will be stored in the app. This is part of the national health record system (the Health Platform) and is protected by national digital solutions for patient records. The Health Platform was developed by Epic Health Care Community [33] and is used worldwide. Participant data submitted for the study will have restricted access for HCPs involved in the study, that is, physicians and nurses at the palliative care unit and research nurses responsible for data collection. These restrictions will be created in the digital system. Data extracted for analysis will be stored in secure data solutions at the University of Bergen.

Quantitative and qualitative data will be analyzed independently before being merged for the final interpretation. The analysis plan focuses on feasibility outcomes, missing data patterns, and descriptive change scores.

We have selected 5 key outcomes for determining feasibility success and progression to a randomized controlled study. These relate to recruitment rates, consent rates, intervention compliance, intervention evaluation, and questionnaire completion rates. Progression criteria for the 5 key feasibility outcomes are presented in Table 2. Despite its importance in feasibility studies, we did not set a progression threshold for study retention due to an expected high level of attrition. We would, for instance, expect that some of the study participants may die during the project, although that would not necessarily indicate a lack of feasibility of the intervention. However, the retention rate will be analyzed and considered when estimating the power of a future RCT. The chosen threshold criteria were determined to be appropriate considering the anticipated deterioration of the population under investigation [34,35]. If feasibility outcomes do not meet the a priori–determined thresholds, an RCT may still be pursued if appropriate modifications can be made to the intervention or study procedures to support a successfully conducted RCT.

As displayed in Table 2, the study will investigate further feasibility outcomes—with no progression criteria—relating to the domains of demand, acceptability, implementation, practicality, and responsiveness. Although not pivotal for determining progression to an RCT, these outcomes will inform the design and planning of a potential future intervention trial.

The study will adhere to the Declaration of Helsinki and its amendments, the conventions of the Council of Europe on Human Rights and Biomedicine, and the corresponding Norwegian laws. All data will be stored on the institution’s secure research server in accordance with national and institution-specific regulations. The study has been approved by the South-East Norway Regional Committee for Medical Research Ethics on December 8, 2025 (938904). All patients will provide written informed consent before enrollment in the study. Written informed consent will be obtained by a research nurse. The study will be registered with the Open Science Framework following in-principle acceptance.

Research on this topic has several potential implications for clinical practice in palliative cancer care. Conforming to the core principles of patient-centered care, the intervention supports shared decision-making, promoting patient autonomy. Weekly electronic symptom reporting allows timely identification of symptom deterioration and rapid clinical response. By replacing rigid, time-based follow-up schedules with need-based contact, the model may reduce unnecessary hospital visits and associated time burdens. For patients with advanced cancer, this could preserve valuable time and improve overall QoL. Including family carers in the intervention acknowledges their role in care and may impact caregiver burden. This holistic approach aligns with the goals of palliative care to support both patients and their families.

The study will comprise a small sample size and be conducted at a single center. However, this is considered appropriate for a feasibility study testing a new intervention, for which generalizability of the results is not applicable. The 6-week intervention period is short, and although it is sufficiently long to test the feasibility of the digital follow-up tool, it may not fully capture the outcome of patients’ health care use. Furthermore, patients with limited digital knowledge may introduce selection bias, potentially excluding some patients and limiting equity in care delivery. The extent of this bias will be determined from recruitment rates and reasons for nonconsent to study participation.

This pilot study will provide critical insights into the feasibility and acceptability of a digital, patient-controlled follow-up model in palliative cancer care. If successful, the intervention could represent a paradigm shift toward more flexible, patient-centered care, reducing time toxicity and improving QoL. The findings will inform the design of a subsequent RCT and may contribute to national strategies for integrating digital health interventions into palliative care.