Screening for sexual dysfunction in young cancer survivors
Stakeholder-Engaged Development and Evaluation of a Screening Approach for Sexual Dysfunction in Adolescent and Young Adult Patients With and Surviving Childhood Cancer
This study is trying out a new way to check for sexual problems in young cancer survivors aged 15-24 to help doctors better understand and support their needs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 205 (estimated) |
| Ages | 15 Years to 24 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05524610 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and implement a standardized screening approach for sexual dysfunction in adolescent and young adult (AYA) patients aged 15-24 who are survivors of childhood cancer. The approach will utilize the Patient Reported Outcome Measurement Information System (PROMIS) for Sexual Function and Satisfaction (SexFS) Brief, integrating feedback from both patients and medical providers. The study will pilot test this screening method across multiple clinics to improve the recognition and management of sexual dysfunction in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 15-24 who are currently receiving care or have survived childhood cancer.
Not a fit: Patients who are not within the age range of 15-24 or who have not been diagnosed with cancer before the age of 18 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of sexual dysfunction in young cancer survivors, enhancing their quality of life.
How similar studies have performed: While there have been studies addressing sexual dysfunction in cancer survivors, this specific approach to screening in AYA patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be aged 15-24 years old at the time of enrollment 4. Patients with or surviving of cancer (must be found in the International Classification of Diseases for Oncology (ICD-O) and have a behavior code ≥2) 5. Must have received cancer-directed therapy with at least one of the following: * Chemotherapy: any anticancer drug to treat the cancer diagnosis including immunotherapy * Radiotherapy: any radiotherapy to treat the cancer diagnosis * Surgery: any surgery to remove cancer including partial or total resections. Biopsies are not considered surgery. 6. Cancer must have been diagnosed before the age of 18 years 7. Patient must have an appointment at one of four clinical sites: CHCO HOPE Survivorship Program, CHCO Oncology Clinic, CHCO Neuro-Oncology Clinic, Seattle Children's Hospital Survivorship Program Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this study: 1. Unable to read and speak English 2. Patients who did not receive cancer-directed therapy 3. Insufficient cognitive functioning to complete study measures, as determined by patient's 4. Participation in intervention development 5. Patient is at end of life or on hospice, as determined by primary oncologist 6. Patients who did not undergo sexual function screening within 1 month of being due will be excluded from implementation outcomes measurement 7. Patient is at end of life or on hospice, as determined by primary oncologist
Where this trial is running
Aurora, Colorado and 1 other locations
- Childrens Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Jenna Demedis — University of Colorado, Denver
- Study coordinator: Barbara Shepperd
- Email: barbara.shepperd@childrenscolorado.org
- Phone: 7207776819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.