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Clinical Trials/NCT05524610
NCT05524610
Recruiting
Not Applicable

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, Denver2 sites in 1 country205 target enrollmentFebruary 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Cancer
Sponsor
University of Colorado, Denver
Enrollment
205
Locations
2
Primary Endpoint
Comparison of sexual function communication before and after intervention implementation
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Detailed Description

Detailed Description: To adhere to National Comprehensive Cancer Network (NCCN) Adolescent and young adult (AYA) and Survivorship Guidelines, the Investigator will be developing and implementing a standardized screening approach for sexual function using the Patient Reported Outcome Measurement Information System (PROMIS) for Sexual Function and Satisfaction (SexFS) Brief. The overarching goal of this proposal is to develop and pilot test a patient-centered approach to assessing AYA patients with and surviving childhood cancer (age 15-24) for SD. Prior to the clinical trial, Aim 1 of this study will integrate patient and provider feedback to refine an approach to standardized sexual function screening. Once Aim 1 has been completed, the study protocol will be amended to update intervention details prior to proceeding with implementation across all clinics as routine clinical care. Aims 2 and 3 involve a pilot type 1 hybrid effectiveness-implementation trial using a pre-post design. Prior to implementation of the intervention, data on sexual function screening and patient satisfaction will be collected through surveys and medical record review. Subsequently, the sexual function screening intervention will be implemented clinic-wide as standard of care for patients age 15-24 years with or surviving childhood cancer. Following implementation of the screening approach, post-implementation data (effectiveness and implementation outcomes) will be collecting via survey and EHR review in consenting patients. After effectiveness data collection is complete, implementation outcomes will also be assessed via surveys and interviews with consenting provider stakeholders.

Registry
clinicaltrials.gov
Start Date
February 14, 2023
End Date
June 30, 2027
Last Updated
10 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Comparison of sexual function communication before and after intervention implementation

Time Frame: 5 years

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.

Secondary Outcomes

  • Comparison of patient satisfaction before and after intervention implementation(5 years)
  • Adoption of the screening tool by medical stakeholders (self-reported results review)(5 years)
  • Patient-reported feasibility of the sexual function screening approach(5 years)
  • Provider-reported feasibility of the sexual function screening approach(5 years)
  • Evaluate implementation of the standardized screening approach by fidelity (patient-reported)(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 discussion)(5 years)
  • Patient-reported acceptability of the sexual function screening approach(5 years)
  • Provider-reported acceptability of the sexual function screening approach(5 years)
  • Patient-reported appropriateness of the sexual function screening approach(5 years)
  • Provider-reported appropriateness of the sexual function screening approach(5 years)
  • Evaluate implementation of the standardized screening approach by fidelity (direct observation)(5 years)
  • Contextual factors influencing implementation success(5 years)

Study Sites (2)

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