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
- Conditions
- Sexual dysfunction and fertility-related distress in young adult (19-40 years of age) survivors of childhood cancer (diagnosis at 0-17 years of age, including all malignant diagnoses and brain tumors)Mental and Behavioural Disorders
- Registration Number
- ISRCTN33081791
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7360293/ (added 12/05/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35845087/ (added 19/07/2022) 2024 Results article in https://doi.org/10.1016/j.invent.2024.100739 (added 17/04/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 4756
The following inclusion criteria will be applied for the Fex-Can Childhood OS:
Cancer survivor group:
1. Individuals diagnosed with malignant disease at the age of 0-17 years and registered in the National Quality Registry for Childhood Cancer.
2. Age 19-40 at the time of enrollment in the study and registered as residents in Sweden.
Comparison group:
Age 19-40 at the time of enrollment (matching the age of the cancer group) and registered as residents in Sweden.
The following inclusion criteria will be applied for the Fex-Can RCT:
Participating in the Fex-Can Childhood OS study (cancer survivor group) and reporting a high level of sexual dysfunction and/or fertility-related distress defined as 0.5 SD from the population mean in any of the selected domains in the SexFS version 2.0 and/or a mean score of 4 or more in at least one dimension of the RCAC respectively.
The following exclusion criteria will be used for the Fex-Can Childhood OS/RCT:
1. Individuals who are unable to read/write in the Swedish language.
2. Participants who report poor health and/or substantial cognitive impairment that prevent completion of the survey/participation in the intervention.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method