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

Official title

Stakeholder-Engaged Development and Evaluation of a Screening Approach for Sexual Dysfunction in Adolescent and Young Adult Patients With and Surviving Childhood Cancer

Overview

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. A subset of patients will also undergo qualitative interviews after consent to this additional study procedure. After effectiveness data collection is complete, implementation outcomes will also be assessed via surveys and interviews with consenting provider stakeholders.

Interventions

• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (12)

• Comparison of patient satisfaction before and after intervention implementation [Time frame: 5 years]
• Comparison of healthcare needs being met before and after intervention implementation [Time frame: 5 years]
• Reach - proportion of eligible patients who completed sexual function screening [Time frame: 5 years]
• Representativeness - sociodemographic characteristics of patients who received and did not receive screening [Time frame: 5 years]
• Adoption of the screening tool by medical stakeholders (self-reported results review) [Time frame: 5 years]
• Adoption of the screening tool by medical stakeholders (self-reported results discussion) [Time frame: 5 years]
• Patient-reported acceptability of the sexual function screening approach [Time frame: 5 years]
• Provider-reported acceptability of the sexual function screening approach [Time frame: 5 years]
• Patient-reported appropriateness of the sexual function screening approach [Time frame: 5 years]
• Provider-reported appropriateness of the sexual function screening approach [Time frame: 5 years]
• Patient-reported feasibility of the sexual function screening approach [Time frame: 5 years]
• Provider-reported feasibility of the sexual function screening approach [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Childrens Hospital Colorado — Aurora
• University of Colorado Hospital — Aurora

Identifiers

NCT: NCT05524610 · 22-0709.ccc · K08CA263192

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗