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

Pediatric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524610
• Other study ID #: 22-0709.ccc
• Secondary ID: K08CA263192
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Barbara Shepperd
• Phone: 7207776819
• Email: barbara.shepperd[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 205
• Est. completion date: June 30, 2027
• Est. primary completion date: March 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Cancer
• Survivorship

Intervention

Behavioral:
• Sexual Function Screening Approach
The screening approach will consist of: 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. 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.

Locations

Country	Name	City	State
United States	Childrens Hospital Colorado	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Referral patterns for sexual function concerns	Comparison the referral patterns before and after implementation of the sexual function screening approach (exploratory)	5 years
Other	Incidence of documented sexual function concerns	Comparison the documentation about sexual function concerns before and after implementation of the sexual function screening approach (exploratory)	5 years
Other	Adoption, as measured by proportion of results that are viewed (objective measure)	Proportion of answered sexual function screening surveys that show evidence of having been viewed (i.e. electronic health record (EHR) clicks)	5 years
Other	Reach - Reason for missed screening	For patients who do not receive screening within 1 month of it being due, reach will be explored via a single multiple choice question to the medical team inquiring into the reasoning for missed screening	5 years
Other	Adaptations to the sexual function screening approach	Qualitative description of documented adaptations to the screening approach as they occur throughout the study.	5 years
Primary	Comparison of sexual function communication before and after intervention implementation	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.	5 years
Secondary	Comparison of patient satisfaction before and after intervention implementation	Comparison of pre- and post-intervention rating of patient satisfaction with sexual function communication. Subjects will report via survey after their healthcare visit. This will be rated on a 10-point scale with 10 being very satisfied and 0 being not at all satisfied.	5 years
Secondary	Comparison of healthcare needs being met before and after intervention implementation	Comparison of pre- and post-intervention percentage of patients with self-identified sexual function needs reporting that this need was met. Subjects will report (yes or no) via survey after their healthcare visit. .	5 years
Secondary	Reach - proportion of eligible patients who completed sexual function screening	Record abstraction evaluating the proportion of eligible patients who completed sexual function screening	5 years
Secondary	Representativeness - sociodemographic characteristics of patients who received and did not receive screening	Comparison of sociodemographic characteristics between eligible patients who did versus did not receive sexual function screening.	5 years
Secondary	Adoption of the screening tool by medical stakeholders (self-reported results review)	Medical stakeholder survey score of a 5-point scale (1=never, 5=every time) on a survey at the conclusion of the study, asking how often they reviewed sexual function screening results with relevant patients	5 years
Secondary	Adoption of the screening tool by medical stakeholders (self-reported results discussion)	Medical stakeholder survey score of a 5-point scale (1=never, 5=every time) on a survey at the conclusion of the study, asking how often they discussed results with patients	5 years
Secondary	Patient-reported acceptability of the sexual function screening approach	Patients will complete a study-specific acceptability survey consisting of several questions on a 5-point scale (0=low acceptability, 5=high acceptability)	5 years
Secondary	Provider-reported acceptability of the sexual function screening approach	Providers will complete the Acceptability of Intervention Measure (AIM), adapted for this study, which consists of several questions on a 5-point scale (0=low acceptability, 5=high acceptability)	5 years
Secondary	Patient-reported appropriateness of the sexual function screening approach	Patients will complete a study-specific appropriateness survey consisting of several questions on a 5-point scale (0=low acceptability, 5=high acceptability)	5 years
Secondary	Provider-reported appropriateness of the sexual function screening approach	Providers will complete the Intervention Appropriateness Measure (IAM), adapted for this study, which consists of several questions on a 5-point scale (0=low appropriateness, 5=high appropriateness)	5 years
Secondary	Patient-reported feasibility of the sexual function screening approach	Patients will complete a study-specific feasibility survey consisting of several questions on a 5-point scale (0=low feasibility, 5=high feasibility)	5 years
Secondary	Provider-reported feasibility of the sexual function screening approach	Providers will complete the Feasibility of Intervention Measure (FIM), adapted for this study, which consists of several questions on a 5-point scale (0=low feasibility, 5=high feasibility)	5 years
Secondary	Evaluate implementation of the standardized screening approach by fidelity (patient-reported)	Patients will respond regarding whether or not they experienced key components (Fidelity Checklist) of the intervention.	5 years
Secondary	Evaluate implementation of the standardized screening approach by fidelity (direct observation)	The study team will evaluate whether key components of the intervention (Fidelity Checklist) are completed via direct observation in 10% of patients across sites.	5 years
Secondary	Contextual factors influencing implementation success	Qualitative description of themes, barriers and facilitators to implementation will be determined via interviews with medical providers after completion of patient enrollment.	5 years