Abstract
BackgroundThis study protocol describes the clinical trial of the Fex-Can intervention, a web-based self-help program targeting sexual dysfunction and fertility-related distress. The psycho-educational intervention has been developed in collaboration with young patients with cancer and shown to be feasible. The primary objective is to determine whether the Fex-Can intervention, provided in addition to standard care, is superior to standard care in terms of reduction of sexual dysfunction and fertility-related distress directly after end of the 12-week program. The trial also aims to determine whether the intervention has an effect on the secondary outcomes including health-related quality of life, anxiety, depression, body image, fertility knowledge, and self-efficacy related to sexuality and fertility.MethodsThe trial has an randomized clinical trial (RCT) design with two parallel arms. The active groups receive either the version of the Fex-Can intervention targeting sexual problems or the version targeting fertility-related distress. Control groups receive standard care. Primary outcomes will be sexual function assessed with the Patient-Reported Outcomes Measurement Information System® Sexual Function and Satisfaction measure version 2.0 (SexFS) and fertility-related distress assessed with the Reproductive Concerns After Cancer scale (RCAC). The effect of the intervention will be evaluated directly after end of the program. Primary and secondary outcomes will also be assessed at the short- (12 weeks after end of program) and long-term (20 and 44 months after end of program) follow-up. At least 64 completers will be needed in each arm (total n = 256) to achieve adequate statistical power in the analyses. In order to increase the understanding of how the intervention brings about a possible change, semi-structured interviews will additionally be conducted with a purposeful sample shortly after completion of the intervention.DiscussionIf the Fex-Can intervention proves to be efficacious the necessary steps will be taken to implement it in routine care for young adults diagnosed with cancer. Healthcare could thereby be provided with an easily accessible, cost-effective intervention to offer to young adults suffering from fertility-related distress or sexual problems.Trial registrationISRCTN36621459. Registered 25 January 2016.
Highlights
This study protocol describes the clinical trial of the Fertility and sexuality following cancer (Fex-Can) intervention, a web-based self-help program targeting sexual dysfunction and fertility-related distress
Numerous studies have reported sexual problems and fertility-related distress to be common among young adults following a cancer diagnosis [1, 9]
The Fex-Can intervention is a web-based self-help program targeting sexual problems and fertility-related distress in young adults diagnosed with cancer
Summary
This study protocol describes the clinical trial of the Fex-Can intervention, a web-based self-help program targeting sexual dysfunction and fertility-related distress. Several of the most common cancer treatments (radiation therapy, chemotherapy, endocrine treatment) may cause these problems directly or indirectly via physiological, psychological, and interpersonal factors [7]. These treatments may cause temporary or permanent infertility or subfertility [8]. A majority of young women with cancer report fertility-related distress at clinical levels, which is related to reduced quality of life and to long-term depressive symptoms [9]. Young people with cancer have themselves ranked both sexual problems and fertility concerns as among their core needs that are unmet by the healthcare today [10,11,12]
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