A digital psychosocial intervention for sexual health after pelvic cancer: A randomized controlled trial
Sexual health problems and reduced sexual wellbeing following treatment for pelvic cancers (prostate, gynaecological, colorectal, and urinary bladder cancer).
Participants will be randomly assigned to either the intervention or control group with a 1:1 ratio. Stratified randomization will be used; the number of stratification variables will be kept to different cancer types included (colorectal, prostate, gynecological and bladder cancer). A blocked randomization list with four participants per block (1 list per strata) will be generated online using the platform Sealed Envelope Ltd. (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by an external researcher. The platform also generates a unique randomization code. Intervention group: An 8‑week digital rehabilitation program delivered on the 1177 "Stöd och behandling" platform. It includes 7 weekly modules with psychoeducation, behavioural exercises, communication and intimacy training, pelvic floor exercises, and gender‑specific content. Each module takes ~60 minutes to complete. Control group: A shorter digital psychoeducational program containing 4 modules delivered every two weeks over 8 weeks. Content overlaps with the intervention but excludes interactive exercises and skills‑based activities. Methodology: Participants complete assessments at baseline, 2 months, and 6 months. The intervention and control programs are accessed remotely. Adherence is tracked via module usage. Concomitant care is allowed.
1. Treated for one of the following pelvic cancer diagnoses: colorectal, prostate, gynaecological or urinary bladder cancer with either surgery, radiation therapy and chemotherapy or a combination of these treatments. 2. Verbally and verified affected sexual health or function with the questionnaire PROMIS Scale v2.0 – Sexual Function Screener. 3. Possess adequate eHealth literacy assessed with the questionnaire eHEALS at baseline. 4. Possess adequate knowledge of the Swedish language. This will be assessed by adequately filling out the screening questionnaires and responses in a brief assessment interview at inclusion. 5. Verbally reported ambition and time to actively work with the rehabilitation intervention for improvements in sexual health. This will be assessed after a brief walkthrough of the intervention regarding the general premise and approximate time needed to complete (around 60 minutes per module/week).
1. In, or is planned for, active treatment for cancer with chemotherapy, radiation or surgery is planned. 2. Active cancer treatment start during the trial period is a reason for exclusion.