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Internet-delivered treatment for fertility distress and sex problems following cancer

An internet-delivered psychoeducational intervention (Fex-Can 2.0) targeting fertility-related distress and sexual dysfunction in young adults diagnosed with cancer: a randomized controlled trial with an internal pilot phase

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18040643
Enrollment
252
Registered
2024-12-12
Start date
2025-11-14
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Young adults diagnosed with cancer who experience fertility-related distress and/or sexual dysfunction Mental and Behavioural Disorders

Interventions

Participants will be randomly allocated using a computer-generated randomization sequence concealed from the researchers to one of the following groups: 1. Intervention group receiving access to the

Sponsors

Uppsala University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 39 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with cancer within the past 5 years 2. Aged 18-39 years at study entry 3. Experiencing significant fertility-related distress and/or sexual problems 4. Prepared to spend at least 30 minutes per week on the intervention website

Exclusion criteria

Exclusion criteria: 1. Inability to communicate in Swedish 2. Suicidality or a significant psychiatric condition

Design outcomes

Primary

MeasureTime frame
1. Self-reported fertility-related distress is measured with the Reproductive Concerns After Cancer scale (RCAC), assessed at baseline, directly after the end of the 12 week intervention, and 12 weeks after end of the intervention. 2. Sexual function and satisfaction is measured by the Patient Reported Outcomes Measurement Information System Sexual Function and Satisfaction (PROMIS SexFS) Brief Sexual Profile, assessed at baseline, directly after the end of the 12 week intervention, and 12 weeks after end of the intervention.

Secondary

MeasureTime frame
1. Degree of bother regarding sexual functioning and use of therapeutic aids for sexual activity is assessed with additional items from the PROMIS SexFS measure. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 2. Body image is assessed with the Body Image Scale (BIS). Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 3. Health-related quality of life is assessed using the EORTC Quality of Life Core Questionnaire (EORTC QLQ-C30). Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 4. Symptoms of anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS). Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 5. Self-efficacy related to fertility is assessed with a study-specific questionnaire. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 6. Self-efficacy related to sex life is assessed with a study-specific questionnaire. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 7. Fertility-related knowledge is assessed with a study-specific questionnaire. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 8. Sex-related knowledge is assessed with a study-specific questionnaire. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 9. Satisfaction with basic psychological needs will be assessed as a mediator, using the Need Satisfaction and Frustration Scale (NSFS), adapted to needs regarding fertility and sexuality, respectively. Assessed at baseline, at mid-intervention (week 6), di

Countries

Sweden

Contacts

Public ContactJohanna Rose
fexcan@uu.se+46 (0)18-471 66 01

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026