Clinical trial · Interventional
Development and Evaluation of a Screening Approach for Sexual Dysfunction in AYA Patients With and Surviving Childhood Cancer
Stakeholder-Engaged Development and Evaluation of a Screening Approach for Sexual Dysfunction in Adolescent and Young Adult Patients With and Surviving Childhood Cancer
NCT05524610CI-TRIAL-00110525recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prior research determined adolescent and young adult-aged childhood cancer survivor (AYA-CCS) and medical provider acceptability of the SexFS Brief in a controlled research setting. Development of an acceptable, effective, and feasible screening approach will result in improved recognition of SD in AYA patients with and surviving childhood cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sexual Function Screening Approach | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Pre-Implementation of Routine Sexual Function Screening (Baseline)
- description
- This arm will include patients with and surviving cancer who are seen during the Pre-Implementation study period. It will include patients diagnosed prior to age 18 years and 15-24 years old at the time of study. Patients will be approached by research personnel at the end of each visit for participation in a survey. The pre-implementation survey will assess sexual function communication and patient satisfaction. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected.
- type
- EXPERIMENTAL
- label
- Post-Implementation of Routine Sexual Function Screening
- description
- This arm will include patients with and surviving cancer who are seen during the Post-Implementation study period, once the routine sexual function screening intervention has been implemented. It will include patients diagnosed prior to age 18 years and 15-24 years old at the time of study. Patients will be approached by research personnel at the end of each visit for participation in a survey. The post-implementation survey will assess sexual function communication and patient satisfaction, as well as measures of acceptability, feasibility, and appropriateness of the intervention. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 24 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.