Background: Studies have shown that supporting parents in pediatric oncology reduces family distress following a cancer diagnosis. Manualized programs for parents have therefore been developed to reduce family distress. However, these programs have limitations that need to be improved, such as better defining programs' procedures, developing interventions focusing on parents' conjugal relationship, conducting rigorous evaluations of implementation, and proposing adaptations to various cultural dimensions. According to the Obesity-Related Behavioral Intervention Trials (ORBIT) model for the development of behavioral intervention, we improved these limitations and developed TAKING BACK CONTROL TOGETHER, a six in-person intervention sessions to support parents of children with cancer by taking the active components of two programs: Bright IDEAS and SCCIP. Referring to the redesign phase of the ORBIT model, this study aims to refine the definition of this program's design by interviewing parents and healthcare professionals.
Methods: In order to refine the program, we used a sequential mixed-methods study. Parents and healthcare professionals first completed questionnaires assessing the program, and then discussed its limitations, benefits, and areas for improvement in group and/or individual interviews. We performed a descriptive thematic content analysis of the qualitative data from the open-ended questions (questionnaires and interviews) with NVivo 11 to categorize recommendations for the program refinement.
Results: The results showed that components seemed pertinent to final users. The main areas needing improvement were the level of complexity and understandability of the parent manual, the possibility to choose the place and time of the intervention, and the lack of ethnic/cultural diversity. Changes to the program were made accordingly.
Conclusions: It is necessary to include end-users when developing complex intervention programs designed for vulnerable populations and sensitive clinical contexts. Following the present refinement, we now have a treatment package, which is safe and acceptable for the target population and has a better chance of yielding a clinically significant benefit for users in a future pilot study.
Keywords: Intervention development; Mixed methods; Parents; Pediatric cancer; Psychosocial intervention; Supportive care.