Study protocol for the Fex-Can Childhood project An observational study and a randomized controlled trial focusing on sexual dysfunction and fertility-related distress in young adult survivors of childhood cancer

Show full item record



Permalink

http://hdl.handle.net/10138/319326

Citation

Ljungman , L , Anandavadivelan , P , Jahnukainen , K , Lampic , C & Wettergren , L 2020 , ' Study protocol for the Fex-Can Childhood project An observational study and a randomized controlled trial focusing on sexual dysfunction and fertility-related distress in young adult survivors of childhood cancer ' , Medicine (Baltimore) , vol. 99 , no. 28 , 19919 . https://doi.org/10.1097/MD.0000000000019919

Title: Study protocol for the Fex-Can Childhood project An observational study and a randomized controlled trial focusing on sexual dysfunction and fertility-related distress in young adult survivors of childhood cancer
Author: Ljungman, Lisa; Anandavadivelan, Poorna; Jahnukainen, Kirsi; Lampic, Claudia; Wettergren, Lena
Contributor: University of Helsinki, Children's Hospital
Date: 2020-07-10
Language: eng
Number of pages: 10
Belongs to series: Medicine (Baltimore)
ISSN: 0025-7974
URI: http://hdl.handle.net/10138/319326
Abstract: Background: This study protocol describes the Fex-Can Childhood project, comprising two studies: The Fex-Can Childhood observational study (OS) and the Fex-Can Childhood randomized controlled trial (RCT). The Fex-Can Childhood OS aims to determine the prevalence and predictors of sexual dysfunction and fertility-related distress in young adult childhood cancer survivors (aged 19-40) compared to an age matched comparison group; the Fex-Can Childhood RCT will evaluate the effect of a web-based psycho-educational intervention (Fex-Can intervention) on sexual dysfunction and fertility-related distress. Methods: The Fex-Can Childhood OS will have a population-based cross-sectional design. All individuals treated for childhood cancer in Sweden at the age of 0 to 17 years (current age 19-40) will be identified through the National Quality Registry for Childhood Cancer. Established self-reported instruments will be used to measure sexual function, fertility-related distress, body image, anxiety and depression, and health-related quality of life. Self-efficacy related to sexual function and fertility, and fertility-related knowledge, will be assessed by study-specific measures. Clinical variables will be collected from the registry. Results will be compared to an age-matched comparison group from the general population. Participants in the Fex-Can Childhood OS who report a high level of sexual dysfunction and/or fertility-related distress will be invited to participate in the RCT. The Fex-Can intervention comprises two programs: The Fex-Can Sex and the Fex-Can Fertility targeting sexual dysfunction and fertility-related distress, respectively. The control condition will be a wait-list. Sexual function and fertility-related distress will be the primary outcomes. The secondary outcomes include body image, anxiety and depression, health-related quality of life and self-efficacy related to sexual function and fertility. Post- and follow-up assessments will be conducted directly after end of intervention (primary end point), at 3 months and 6 months after end of intervention. Additionally, a process-evaluation including study-specific items and a qualitative interview will be conducted. Discussion: The Fex-Can Childhood project will advance knowledge in the areas of sexual function and fertility-related distress among young adult survivors of childhood cancer. If the Fex-Can intervention proves to be efficacious, steps will be taken to implement it in the follow-up care provided to this population.
Subject: childhood cancer
fertility-related distress
intervention
observational study
randomized controlled trial
sexual function
survivors
young adults
QUALITY-OF-LIFE
FEMALE SURVIVORS
REPRODUCTIVE CONCERNS
ROMANTIC RELATIONSHIPS
HOSPITAL ANXIETY
INFERTILITY
IMPACT
SCALE
INTERNET
HEALTH
3121 General medicine, internal medicine and other clinical medicine
3123 Gynaecology and paediatrics
Rights:


Files in this item

Total number of downloads: Loading...

Files Size Format View
_Study_protocol ... n_Childhood_project_.2.pdf 488.3Kb PDF View/Open

This item appears in the following Collection(s)

Show full item record