An internet-delivered psychoeducational intervention (Fex-Can 2.0) targeting fertility-related distress and sexual dysfunction in young adults diagnosed with cancer: Study protocol of a randomized controlled trial with an internal pilot phase
Can an internet-delivered psychoeducational intervention (called Fex-Can 2.0) effectively help young adult cancer survivors who experience fertility-related distress and/or sexual dysfunction following their cancer diagnosis and treatment?
College of Health researcher(s)
Abstract
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
Fex-Can 2.0: Addressing Fertility and Sexual Health Challenges in Young Adults with Cancer
What is Fex-Can 2.0?
Fex-Can 2.0 is an internet-delivered psychoeducational intervention designed to help young adults (aged 18–39) who have been diagnosed with cancer within the past 5 years and are experiencing significant fertility-related distress and/or sexual problems. It aims to provide support and resources through structured modules delivered online over a 12-week period.
Why is an intervention like Fex-Can 2.0 needed?
Cancer and its treatments can have significant negative effects on fertility and sexuality in young adults. This often leads to considerable fertility-related distress and sexual dysfunction, impacting their quality of life, emotional well-being, partner relationships, and body image. Despite these common challenges, there is a lack of evidence-based interventions specifically targeting these issues in this population. Fex-Can 2.0 was developed to address this gap and provide accessible support, especially for a geographically dispersed population.
What kind of content does Fex-Can 2.0 include?
Fex-Can 2.0 utilizes a guided self-help format delivered through modules. These modules contain psychoeducational and behavior-change content, including information about fertility and sexuality (general and cancer-specific), multimedia resources, personal stories from other young adult cancer survivors, self-monitoring exercises, interactive components like quizzes and reflective questions, and exercises inspired by mindfulness and Cognitive Behavioral Therapy (CBT). Participants also have access to a moderated asynchronous peer discussion forum. The content is individually recommended based on a start-up session with a research team member.
What are the primary goals of the Fex-Can 2.0 study?
The primary objective of the Fex-Can 2.0 randomized controlled trial (RCT) is to determine the efficacy of the intervention in reducing fertility-related distress and sexual dysfunction in young adults diagnosed with cancer. This will be assessed at the end of the 12-week intervention period.
How will the effectiveness of Fex-Can 2.0 be measured?
The primary outcomes measured in the study are fertility-related distress, assessed using the Reproductive Concerns After Cancer scale (RCAC), and sexual function and satisfaction, assessed using the PROMIS Sexual Function and Satisfaction measure version 2.0 Brief Profile (PROMIS® SexFS BSP v2.0). Secondary outcomes, such as body image, emotional distress, health-related quality of life, fertility- and sex-related knowledge, and self-efficacy, will also be assessed.
What is the theoretical basis for Fex-Can 2.0?
The Fex-Can 2.0 intervention is guided by Self-Determination Theory (SDT). SDT posits that humans have three basic psychological needs: competence (feeling effective), autonomy (sense of control), and relatedness (need to connect with others). The intervention's content and delivery are designed to support these needs, aiming to enhance participants' autonomous motivation to engage with the program and, consequently, experience greater impact on their fertility-related distress and/or sexual dysfunction.
What is the purpose of the internal pilot phase in the study?
The study includes an internal pilot phase involving the first 70 enrolled participants. The purpose of this phase is to assess the feasibility and acceptability of the Fex-Can 2.0 intervention and the study procedures before proceeding with the full-scale RCT. This includes evaluating recruitment rates, data collection processes, participant dropout and adherence rates, and participants' experiences with the intervention through semi-structured interviews. This allows for potential amendments to the study design or intervention if needed, based on pre-specified progression criteria.
How does Fex-Can 2.0 differ from standard care?
Standard care in Sweden, according to national guidelines, recommends that healthcare professionals inform patients about the potential impact of cancer and treatment on sexual and reproductive health and assess their rehabilitation needs. However, previous research indicates that not all patients receive this information or targeted support. The Fex-Can 2.0 intervention provides a structured, internet-delivered program with specific psychoeducational and behavior-change content tailored to address fertility-related distress and sexual dysfunction, which may not be consistently provided in standard care. The study compares the outcomes of the intervention group receiving Fex-Can 2.0 to a control group receiving standard care.