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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05524610
Status
Recruiting
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Conditions

  • Pediatric Cancer
  • Survivorship

Eligibility Criteria

Sex
ALL
Age
15 Years - 24 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 14, 2023
Status verified
May 2026
Primary completion
Mar 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
205 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Pre-Implementation of Routine Sexual Function Screening (Baseline)
    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.
  • Experimental: Post-Implementation of Routine Sexual Function Screening
    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.

Primary Outcome Measure

Comparison of sexual function communication before and after intervention implementation [ Time Frame: 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Childrens Hospital ColoradoAuroraColorado80045
Barbara Shepperd
[email protected]
7207776819
University of Colorado HospitalAuroraColorado80045
Barbara Shepperd
[email protected]
7207770188
Jenna Demedis (PRINCIPAL_INVESTIGATOR)

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By research site
Childrens Hospital Colorado· Aurora, COUniversity of Colorado Hospital· Aurora, CO

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