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

INTERVENTION: 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 group from the general population. The childhood cancer survivors will be identified via the National Swedish Childhood Cancer Registry, and survivors who are young adults (19‐40 years of age, approximately 4500 individuals) will be invited to complete a survey. The survey will include questions regarding sexual problems, fertility‐related distress, anxiety and depression, body image, and health‐related quality of life. The same survey has been sent to an age‐matched comparison group from the general population (approximately 2000 individuals). Childhood cancer survivors who report high levels of sexual problems and/or fertility‐related distress will thereafter be invited to the second part of the Fex‐Can Childhood project. Fex‐Can Childhood RCT: The Fex‐Can Intervention is a web‐based self‐help intervention that comprises two programs targeting sexual dysfunction and fertility‐related distress respectively; 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 feasibility with satisfying results. Both the Fex‐Can Sex and the Fex‐Can Fertility programs are structured in six modules to be delivered over a period of 12 weeks. The programs consist of texts, video vignettes with young adult survivors of childhood cancer discussing the topics covered, exercises, and an online‐moderated discussion forum. Randomization will be conducted to either the intervention group or to a wait‐list control‐condition with an allocation ratio of 1:1. Participants will be allocated in blocks stratified by sex and diagnosis and randomization will be made separately for the two versions of the intervention (Fex‐Can Sex and CONDITION: 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 PRIMARY OUTCOME: ; 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 OUTCOME: ; 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; 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