City Research Online

A web-based psycho-educational intervention (Fex-Can) targeting sexual dysfunction and fertility-related distress in young adults with cancer: study protocol of a randomized controlled trial.

Lampic, C., Ljungman, L., Micaux Obol, C., Eriksson, L. E. ORCID: 0000-0001-5121-5325 and Wettergren, L. (2019). A web-based psycho-educational intervention (Fex-Can) targeting sexual dysfunction and fertility-related distress in young adults with cancer: study protocol of a randomized controlled trial.. BMC Cancer, 19, 344.. doi: 10.1186/s12885-019-5518-3

Abstract

BACKGROUND: 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. 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.

METHODS: The 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.
DISCUSSION: If 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.

Publication Type: Article
Additional Information: © The Author(s). 2019Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Departments: School of Health Sciences > Nursing
URI: http://openaccess.city.ac.uk/id/eprint/22115
[img]
Preview
Text - Published Version
Available under License Creative Commons Attribution.

Download (1MB) | Preview

Export

Downloads

Downloads per month over past year

View more statistics

Actions (login required)

Admin Login Admin Login