Web-based treatment of fertility-related distress and sexual problems after cancer – a randomized controlled pilot trial testing the Fex-Can 2.0 program

The Fex-Can project was initiated 2013 with the ultimate goal to improve reproductive and sexual health in young adults with cancer. The project includes a cohort study with an embedded RCT.

The evaluation of the web-based psycho-educational intervention showed short-term effects on some outcomes, however not in line with what was hypothesized.

Contrasting these results, a majority of the RCT participants rated improvement with their concerns/problems and appreciation with the intervention.

This application regards funding for revising the intervention in two ways: the thresholds for inclusion will be changed to select the men and women being most troubled, and new features will be added to increase intervention adherence.

The adapted intervention (version 2.0) will undergo testing according to predefined progression criteria following the CONSORT 2010 statement for randomized pilot and feasibility trials.

A two-armed internal pilot RCT (N=80) with a waitlist control group will be conducted to test the feasibility of the Fex-Can (2.0) intervention in young adults with cancer, in preparation for a full scale RCT.

The specific aims are to:Evaluate the recruitment procedures and attrition rates.Evaluate the appropriateness and acceptability of the intervention.Estimate variance and between-group differences in outcomes before and after the intervention between the two groups (intervention/standard care).