ABSTRACT: BACKGROUND:Distress is prevalent in cancer survivors. Stress management interventions can reduce distress and improve quality of life for cancer patients, but many people with cancer are unfortunately not offered or able to attend such in-person stress management interventions. OBJECTIVE:The objective of this study was to develop an evidence-based stress management intervention for patients living with cancer that can be delivered electronically with wide reach and dissemination. This paper describes the design and development process of a technology-based stress management intervention for cancer survivors, including the exploration phase, intervention content development, iterative software development (including design, development, and formative evaluation of low- and high-level prototypes), and security and privacy considerations. METHODS:Design and development processes were iterative and performed in close collaboration with key stakeholders (N=48). In the exploration phase, identifying needs and requirements for the intervention, 28 participants gave input, including male and female cancer survivors (n=11) representing a wide age range (31-81 years) and cancer diagnoses, healthcare providers (n=8) including psychosocial oncology experts, and eHealth experts (n=9) including information technology design and developers. To ensure user involvement in each phase various user-centered design and service design methods were included, such as interviews, usability testing, and think aloud processes. Overall, participants were involved usability testing in the software development and formative evaluation phase, including cancer survivors (n=6), healthy volunteers (n=7), health care providers (n=2), and eHealth experts (n=5). Intervention content was developed by stress management experts based on well-known cognitive behavioral stress management strategies and adjusted to electronic format through multiple iterations with stakeholders. Privacy and security issues were considered throughout. RESULTS:The design and development process identified a variety of stakeholder requirements. Cancer survivors preferred stress management through a mobile app rather than through a personal computer (PC) and identified usefulness, easy access, user friendliness, use of easily understandable language, and many brief sections rather than longer ones as important components of the intervention. These requirements were also supported by recommendations from health care providers and eHealth experts. The final intervention was named StressProffen and the hospital Privacy and Security Protection Committee was part of the final intervention approval to also ensure anchoring in the hospital organization. CONCLUSIONS:Interventions, even evidence-based, have little impact if not actively used. This study illustrates how user-centered design and service design can be applied to identify and incorporate essential stakeholder aspects in the entire design and development process. In combination with evidence-based concepts, this process facilitated development of a stress management intervention truly designed for the end users, in this case, cancer survivors. TRIAL REGISTRATION:ClinicalTrials.gov NCT02939612; https://clinicaltrials.gov/ct2/show/NCT02939612 (Archived at WebCite at http://www.webcitation.org/71l9HcfcB).
