Objective: Fertility-related distress and sexual dysfunction following cancer is a major threat to quality of life in survivorship. Fex-Can 2.0 is an internet intervention developed to alleviate such problems among young adult (18-39 years) cancer survivors through provision of educational and behavior change content, self-management tools, and support. The study protocol of the Fex-Can 2.0 internal pilot study and randomized controlled trial (RCT) will be presented in detail.
Methods: The study will be performed in a parallel two-armed superiority RCT with an internal pilot phase. The primary objective is to determine the efficacy of the Fex-Can 2.0 intervention in terms of reduction of fertility-related distress and sexual dysfunction. The internal pilot study will assess feasibility of the study, determined according to pre-specified progression criteria on recruitment, attrition, adherence and resources. Primary and secondary outcomes will be assessed at baseline, at end of the intervention, and 12 weeks after end of the program. Primary outcomes are fertility-related distress (RCAC) and sexual function and satisfaction (PROMIS® SexFS v2.0).
Conclusion and implications: Findings from this study will determine the feasibility and efficacy of the Fex-Can 2.0 intervention. As no intervention is available for use among health care providers of young cancer patients in Sweden today, the Fex-Can 2.0 may, if proven efficacious, have significant clinical implications through improving care provided to young adults diagnosed with cancer.