The study was conducted in the pediatric hemato-oncology unit in the Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia. This unit is the country’s main referral center for child cancer treatment. It provides care delivered by pediatric hemato-oncologists, pediatric hemato-oncology fellows, pediatric residents, oncology nurses, and generic nurses. The unit also has social workers and psychologists. Each year, the unit provides care for about 600 new cases of children with cancer. Cancer treatment in this unit mainly involves chemotherapy, radiotherapy, and surgery.

A descriptive, exploratory qualitative study is being used to assess the prospective acceptability of the newly designed PairEd-C intervention using the theoretical framework of acceptability (TFA).

Since our objective is to assess acceptability from the perspectives of both parents of children with cancer and HCPs, the study participants were the parents of children with cancer and HCPs (physicians, nurses, social workers, and team leaders) working in the unit. In addition, policymakers were interviewed to get their perspectives on the intervention. Parents of children with cancer who visit the pediatric oncology unit and met our inclusion criteria were invited to participate in the in-depth interview. We anticipated recruiting a total of 5 parents of children with cancer. During the selection of parents, maximum variation was maintained by residence, education status, and type of childhood cancer. We planned to include 10 HCPs (physicians, nurses, and psychologists) in the in-depth interviews. During the selection of HCPs, responsibility in the unit, service year at pediatric oncology, working area, and level of education were considered. Saturation determined the final number of study participants.

We adapted the TFA developed by Sekhon et al [15] to guide this study [15]. The TFA is designed explicitly to assess the acceptability of health care interventions from the perspectives of people receiving and delivering interventions. It sets out a theory-informed structure based on participants’ cognitive and emotional responses [15]. It consists of 7 conceptually different constructs that capture the following essential acceptability dimensions: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy [15]. See Figure 1. It can be applied before, during, or after an intervention to assess prospective, concurrent, and retrospective acceptability. Since its development in 2017, it has been applied in varied contexts for these purposes [24-27]. It has also been used for structured data analysis [26,28-31], developing questionnaires [32,33], and informing an interview guide development [24,27,32-34]. The TFA can be applied using quantitative, qualitative, or mixed study approaches.

For this study, the TFA is suitable since its concepts are applicable for evaluating an intervention in individual, interpersonal, and community contexts. Similarly, the PairEd-C intervention is planned to be delivered to parents of children with cancer coming from different socioeconomic backgrounds. As a result, to evaluate it, a framework with components that are applicable to assessing how context-specific demands are met by providing a workable and culturally relevant solution must be used. Therefore, we planned to evaluate acceptability as the perception among beneficiaries and intervention implementers. This aids in determining whether the current intervention will be agreeable, palatable, or satisfactory. This will help to obtain more collective feedback about the nature of the PairEd-C intervention from different stakeholders [15,35]. In addition, assessing anticipated acceptability before participation can highlight which aspects of the intervention could be modified to increase acceptability and, thus, participation [15].

The PairEd-C intervention was developed by integrating the Medical Research Council (MRC) [23] and behavior change wheel (BCW) [36] models. These theoretical foundations were used for similarly designed interventions in different setups. The BCW was developed from frameworks of behavior change and includes the behavior system known as COM-B at the center [36]. COM-B includes capability (C), opportunity (O), and motivation (M), which ultimately interact to produce behaviors (B) [36]. Parents’ behaviors that require modification include their intention to be involved in their child’s care, to ask and communicate with HCPs, and communicate with other parents of children with cancer. The BCW includes 9 intervention functions and 7 policy categories that support intervention design [36]. The main PairEd-C intervention components will align with the following intervention functions: education, persuasion, training, environmental restructuring, modeling, and enablement. These intervention functions are intended to improve FCC at the pediatric oncology unit through the provision of structured and comprehensive education and counseling for parents of children with cancer.

The main intervention components are providing training for the health care team, discussion among HCPs and setting a shared plan, improving commitment of the health care team, providing education for parents, improving parents’ capacity to attend, monitoring and using the intervention, arranging discussion among parents of children with cancer, and education and counseling on distress. The HCPs will receive training on the designed intervention. The trained HCPs will be responsible for implementing the other components, including providing training to parent-peer educators. The trained educators, with the HCP, will be involved in providing education for parents, facilitating discussion among parents, improving parenting capacity, and providing education and counseling on stress management. The detailed intervention description is presented using the Template for Intervention Description and Replication checklist. See Table 1. Figure 2 presents a logic model developed to link the health care systems context, such as the study setting, resources, intervention activities, theory and assumptions underlying the intervention, and the intervention plan, in a logical order. In addition, Figure 3 shows the implementation flow of the intervention components for the provision of comprehensive, structured education and counseling for parents of children with cancer.

Before data collection, a summarized description of the intervention prepared in the local language, Amharic, was provided to the study participants. The description of the intervention includes the major activities provided in Table 1. In addition, detailed answers were provided for any questions raised by the study participants. Data were collected in an in-depth interview using a semistructured interview guide. The interview guide was developed based on the 7 dimensions of the TFA by Sekhon et al [15] as applied to the designed intervention. See Table 2. We used recommendations from the study by Sekhon et al [38] and similar studies to develop the interview guide [24,34,39]. For instance, “burden” was explored with the question, “How easy or difficult do you think to participate in the parent education or counseling sessions?” The interview guides were pilot tested after they were independently evaluated by 2 researchers with experience in public health and complex behavior change interventions. We used the process of “back coding” to check whether the interview guide aligns with TFA constructs. A draft interview guide with opening and closing questions arranged in a random sequence and a list of the TFA structures was sent to the implementation researchers. They were asked to indicate which TFA construct each question addressed and rate how certain they were of the match on a scale from 1 to 5 (1=not at all sure; 5=sure). This process was used to assess the construct validity and whether the interview guide adequately represented the constructs in the framework [40]. All interviews were digitally recorded using a portable audio recorder and transcribed verbatim.

Qualitative data analysis will involve both deductive and inductive qualitative content analyses. Deductive thematic coding was used with a framework analysis technique based on the 7 constructs of the TFA [15]. In this phase, the text units were condensed, coded, and labeled using the participants’ own words as much as possible. Two independent researchers coded all transcripts, resolving discrepancies through consensus or discussion with a third party. During the coding process, quotes were determined to be generally positive, negative, or neutral toward the designed intervention. Similar codes were merged into key themes and categorized into domains of the TFA where applicable. Themes that did not fit within the constructs and domains of the TFA were also listed as new insights that emerged from the interview. In addition, continuous data analysis was performed following each in-depth interview. A saturation evaluation was conducted, and data collection ceased once data saturation was reached during analysis and no new categories were identified. Atlas.ti version 9 was used for data management. To ensure trustworthiness, we used triangulation, debriefing, and member checking [41]. Triangulation involved cross-verifying data from various sources, including parents, nurses, oncologists, and head nurses.

Ethical clearance was obtained from the Addis Ababa University College of Health Science institutional review board (protocol number 022/22/SPH). Permission was obtained from the TASH pediatric oncology unit. Written informed consent for the interviewee was obtained from each study participant. Participants were assured of their right to withdraw from the interview at any time, and participation in this study or refusal to participate did not affect their ability to access health services or any other services. Names and other personal information were not taken nor recorded. All information is kept confidential.

This study’s findings will be published in an open-access journal and via national and international conference presentations.

This study protocol describes the evaluation of the prospective acceptability of a newly designed intervention to improve FCC in the pediatric oncology setting in Ethiopia. A panel of experts in the field of pediatric oncology will modify the designed intervention based on information obtained from baseline surveys, international experiences, and their expertise. Although FCC is highly flexible and can be applied in a multitude of health care settings [42], studies on the design and evaluation of an FCC intervention in low-income countries are scarce. An intervention protocol to implement FCC in pediatric oncology settings is lacking in Ethiopia. Acceptability studies for health care interventions are becoming more widely recognized as a necessary condition [21], and the TFA has been successfully used to explore acceptability in health promotion interventions [28]. Therefore, this prospective acceptability study will establish strong foundational evidence that will play a vital role in the success of the newly developed intervention. In addition, the acceptability study will help to identify factors that would facilitate the acceptability of interventions to improve the designed family-centered education and counseling programs. The findings will also determine the strengths and weaknesses of the proposed intervention. We will also benefit from aligning the intervention with existing child cancer treatment.

The strength of this study is that we used a widely used framework as guidance. Having an intervention developed based on locally generated information and experts who understand the available setup will facilitate the acceptability of the intervention. Involving health service leaders, HCPs, social workers, and parents of children with cancer will help obtain more comprehensive information about the possible acceptability of the designed intervention. Regarding possible limitations of the study, parents’ feedback might be biased due to their anticipation of trying something new. Social desirability bias might be introduced because of the nature of the study’s interviews. In addition, the transferability of the findings might be limited due to the purposive nature of participant selection.

The results of this acceptability study will indicate that the designed intervention will be well received and accepted. The feedback obtained from parents, HCPs, and policymakers will be positive for all domains of the TFA. The education and counseling methods designed in the proposed intervention will significantly improve parents’ understanding of their children’s illness and enhance their capacity to provide care. It will also help fulfill the information needs of parents of children with cancer. In addition, we expect study participants will respond, as the intervention will help reduce parental psychological distress that is caused by their child’s diagnosis of cancer. Components of the proposed intervention, such as its detailed nature, inclusion of HCPs, peer educator training, delivery of information using multiple methods, and integrated delivery of the intervention with regular care, will help make it more acceptable among parents and HCPs. The outcome of this study will also help identify possible challenges that might affect the implementation of the study. Furthermore, the findings will help identify potential areas of improvement.