Clinical trial NCT05524610: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Survivorship
Keywords: Cancer Survivor
Cancer Patient
Young Adult
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-09-01
Enrollment: 205
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of sexual function communication before and after intervention implementation
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of patient satisfaction before and after intervention implementation
timeFrame: 5 years
measure: Comparison of healthcare needs being met before and after intervention implementation
timeFrame: 5 years
measure: Reach - proportion of eligible patients who completed sexual function screening
timeFrame: 5 years
measure: Representativeness - sociodemographic characteristics of patients who received and did not receive screening
timeFrame: 5 years
measure: Adoption of the screening tool by medical stakeholders (self-reported results review)
timeFrame: 5 years
measure: Adoption of the screening tool by medical stakeholders (self-reported results discussion)
timeFrame: 5 years
measure: Patient-reported acceptability of the sexual function screening approach
timeFrame: 5 years
measure: Provider-reported acceptability of the sexual function screening approach
timeFrame: 5 years
measure: Patient-reported appropriateness of the sexual function screening approach
timeFrame: 5 years
measure: Provider-reported appropriateness of the sexual function screening approach
timeFrame: 5 years
measure: Patient-reported feasibility of the sexual function screening approach
timeFrame: 5 years
measure: Provider-reported feasibility of the sexual function screening approach
timeFrame: 5 years
measure: Evaluate implementation of the standardized screening approach by fidelity (patient-reported)
timeFrame: 5 years
measure: Evaluate implementation of the standardized screening approach by fidelity (direct observation)
timeFrame: 5 years
measure: Contextual factors influencing implementation success
timeFrame: 5 years
Other outcomes:
measure: Referral patterns for sexual function concerns
timeFrame: 5 years
measure: Incidence of documented sexual function concerns
timeFrame: 5 years
measure: Adoption, as measured by proportion of results that are viewed (objective measure)
timeFrame: 5 years
measure: Reach - Reason for missed screening
timeFrame: 5 years
measure: Adaptations to the sexual function screening approach
timeFrame: 5 years
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jenna Demedis
role: PRINCIPAL_INVESTIGATOR
References: