Development and Evaluation of a Screening Approach for Sexual Dysfunction in AYA Patients With and Surviving Childhood Cancer

NCT05524610 | Recruiting DMC

• 2 other identifiers: 22-0709.cccK08CA263192
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pediatric Cancer; Survivorship

Keywords

Cancer Survivor; Cancer Patient; Young Adult

Outcome Measures

Primary Outcomes (1)

• Comparison of sexual function communication before and after intervention implementation

  Comparison of pre- and post- intervention percentage of patients reporting that his/her provider has communicated with them about sexual function Subjects will report (yes or no) via survey after their healthcare visit.

  5 years

Secondary Outcomes (15)

• Comparison of patient satisfaction before and after intervention implementation

  5 years

• Comparison of healthcare needs being met before and after intervention implementation

  5 years

• Reach - proportion of eligible patients who completed sexual function screening

  5 years

• Representativeness - sociodemographic characteristics of patients who received and did not receive screening

  5 years

• Adoption of the screening tool by medical stakeholders (self-reported results review)

  5 years

Other Outcomes (5)

• Referral patterns for sexual function concerns

  5 years

• Incidence of documented sexual function concerns

  5 years

• Adoption, as measured by proportion of results that are viewed (objective measure)

  5 years

Study Arms (2)

Pre-Implementation of Routine Sexual Function Screening (Baseline)

NO INTERVENTION

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.

Post-Implementation of Routine Sexual Function Screening

EXPERIMENTAL

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.

Behavioral: Sexual Function Screening Approach

Interventions

Sexual Function Screening Approach BEHAVIORAL

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.

Also known as: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) Sexual Function and Satisfaction (SexFS) Brief v2.0 tool

Post-Implementation of Routine Sexual Function Screening

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

National Institutes of Health (U.S.)

Intervention Hierarchy (Ancestors)

Academies and Institutes; Organizations; Health Care Economics and Organizations; United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government

Study Officials

• Jenna Demedis

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Shepperd

CONTACT

7207776819; barbara.shepperd@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 1, 2022
• Study Start: February 14, 2023
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)