Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05524610

Conditions

Pediatric Cancer

Survivorship

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Interventions

Sexual Function Screening Approach

Study Details

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

Study ID

NCT05524610

Start date

Feb 14, 2023

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

205 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Sexual Function Screening Approach

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

Childrens Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Jenna Demedis

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Cancer Survivor
  • Cancer Patient
  • Young Adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-06.