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
University of Colorado, Denver
205 participants
Feb 14, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be aged 15-24 years old at the time of enrollment
- 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)
- 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.
- Cancer must have been diagnosed before the age of 18 years
- 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 Criteria8
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to read and speak English
- Patients who did not receive cancer-directed therapy
- Insufficient cognitive functioning to complete study measures, as determined by patient's
- Participation in intervention development
- Patient is at end of life or on hospice, as determined by primary oncologist
- Patients who did not undergo sexual function screening within 1 month of being due will be excluded from implementation outcomes measurement
- Patient is at end of life or on hospice, as determined by primary oncologist
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Interventions
The screening approach will consist of: 1. Standardized use of the PROMIS SexFS Brief in a clinic setting. This tool assesses sexual interest/desire, arousal, discomfort/pain, climax, and satisfaction, among other SD concerns and has comparable sex-specific versions. It has been validated in adult cancer populations. 2. An implementation package to aid in successful implementation. The implementation package will be finalized in the non-trial portion of this study, which will include iterative intervention adaptation. The protocol will be amended as needed to include any relevant updates to the screening approach. Some components may vary per site.
Locations(2)
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NCT05524610