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
Conditions
Interventions
In the first study the researchers will investigate sexual problems and fertility-related distress in a large group of childhood cancer survivors and compare the results with an age-matched comparison
The Fex-Can Sex and the Fex-Can Fertility. The intervention has been developed together with young adult survivors of cancer as research partners. The intervention has been evaluated as to its feasibi
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fex-Can Childhood RCT: 1. Sexual function, measured with the Patient-Reported Outcomes Measurement Information System? Sexual Function and Satisfaction Measure version 2.0 (SexFS version 2.0), directly after the end of the intervention (primary endpoint), at 3 months after the end of the intervention (short-term follow-up), and at 6 months after end of the intervention (long-term follow-up). 2. Fertility-related distress, assessed with the Reproductive Concerns After Cancer scale (RCAC), directly after the end of the intervention (primary endpoint), at 3 months after the end of the intervention (short-term follow-up), and at 6 months after the end of the intervention (long-term follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fex-Can Childhood RCT: Measured directly after the end of the intervention (primary endpoint), at 3 months after the end of the intervention (short-term follow-up), and at 6 months after the end of the intervention (long-term follow-up): 1. Body image assessed with the Body Image Scale (BIS) 2. Anxiety and depression assessed with the Hospital Anxiety and Depression scale (HADS) 3. Health-related quality of life measured with the EORTC QLQ-C30 (version 3.0) 4. Self-efficacy related to sexual function and fertility assessed with study-specific questions measuring confidence in one’s own ability to handle situations, thoughts and emotions related to sexuality (6 items) and to the threat of infertility (6 items) 5. Perceived level of knowledge about general and cancer-related fertility issues examined by a study-specific questionnaire with 10 items | — |
Countries
Sweden
Outcome results
None listed