Logotyp: till Uppsala universitets webbplats

ObjectiveTo test the efficacy of a web-based psychoeducational intervention, Fex-Can Sex, in reducing sexual dysfunction in young adults with cancer.

MethodsThis randomized controlled trial evaluated a 12-week web-based self-help intervention. Young adults aged 19–40 who reported sexual dysfunction 1.5 years after cancer diagnosis were drawn from a population-based cohort. Participants were randomized to an intervention group (IG, n = 72) or a control group (CG, n = 66) that solely received standard care. Primary outcome was assessed by a domain of the Patient Reported Outcome Measures Information Systems® SexFS: “Satisfaction with sex life.” Secondary outcomes included additional SexFS domains, body image (BIS), emotional distress (HADS), health-related quality of life (EORTC QLQ-C30), and self-efficacy related to sex. Surveys were completed at baseline, post-intervention, and three months later. Effects of the intervention were tested with t-tests, and linear mixed models (LMMs), including intention-to-treat and subgroup analyses. Additionally, the IG was asked about their experiences of the program with study-specific questions.

ResultsThere were no differences in primary or secondary outcomes between the IG and the CG at post-intervention. Subgroup analyses showed that individuals with greater sexual problems at baseline improved over time, regardless of group allocation. Participants spent a mean time of 20.7 min on the program. The study-specific items showed that the majority of participants in the IG appreciated the program and would recommend it to others.

ConclusionThe Fex-Can Sex intervention did not show effect on primary and secondary outcomes. Adherence to the intervention was low, and future interventions are recommended to include more interactive components to enhance usage.

Clinical trial registrationThe trial was registered on 25 January, 2016 (trial number: 36621459).

Objective: This study sought to investigate interactive participation and content of a moderated discussion forum within a web-based psychoeducational intervention aimed at alleviating sexual dysfunction and fertility distress in young adults diagnosed with cancer.

Methods: The study is part of the Fex-Can Young Adult randomized controlled trial (RCT), in which young adults with self-reported sexual dysfunction or fertility distress were invited to participate. This study focuses on RCT participants that were randomized into the intervention condition. Sociodemographics and clinical characteristics of intervention participants and level of activity in the intervention were analyzed with descriptive statistics and compared between subgroups (“high” and “low” activity participants). Inductive qualitative thematic analysis was used to analyze the posts in the discussion forum.

Results: Of 135 intervention participants, 24% met the criteria for high activity participation. There were no statistically significant differences found in terms of clinical and sociodemographic characteristics between high and low activity participants. Ninety-one participants (67%) accessed the discussion forum, and 19 (14%) posted at least once. Posters shared intimate details of their experiences of sexuality and fertility following cancer. The thematic analysis of posts resulted in four themes: fertility fears, perceptions of the changed body, missing out on life, and importance of support and information.

Conclusions: While a smaller proportion of participants posted in the discussion forum, a majority spent time reading posts (lurkers). Participants posting in the forum shared experiences of intimate relationships, body image, parenthood concerns, and support needs. The discussion forum was used by a majority of intervention participants, and provided appreciated support for those who posted in the forum. We therefore recommend similar interventions to include this opportunity for interaction and communication.

Background

While previous literature has continuously demonstrated the negative effects of cancer and its treatment on fertility and sexuality, evidence-based interventions to alleviate fertility-related distress and sexual dysfunction are lacking. This study protocol describes the internal pilot study and randomized controlled trial of an internet-delivered psychoeducational intervention: Fex-Can 2.0. The primary objective is to determine efficacy of Fex-Can 2.0 in terms of reduction of fertility-related distress and sexual dysfunction at end of the 12-week intervention. The internal pilot study will assess feasibility of the study, determined according to pre-specified progression criteria and individual interviews.

Methods

The study has a randomized controlled design, with an internal pilot phase. The intervention group will receive Fex-Can 2.0, consisting of psychoeducational- and behavior change content. The control group will be allocated to standard care. Primary outcomes are fertility-related distress (RCAC) and sexual function and satisfaction (PROMIS SexFS Brief Sexual Profile). Secondary outcomes include body image (BIS), emotional distress (HADS), health-related quality of life (EORTC QLQ-C30), need satisfaction and frustration scale (NSFS), fertility- and sex-related knowledge, and self-efficacy related to fertility and sex life. Outcomes will be assessed at baseline, directly after the intervention, and 12 weeks later. During the internal pilot, data on trial recruitment, data collection, drop out, and adherence will be collected to assess feasibility. Semi-structured interviews will be conducted to further assess acceptability of Fex-Can 2.0.

Conclusions

This randomized controlled trial aims to evaluate whether Fex-Can 2.0 is superior to standard care, in terms of reducing fertility-related distress and sexual dysfunction in young adults diagnosed with cancer. If proven efficacious, the Fex-Can 2.0 intervention may be a valuable resource in health care, with the potential to significantly improve the care of young adults experiencing fertility-related distress and/or sexual dysfunction following cancer.

Trial registration

ClinicalTrials.gov ISRCTN18040643