Development and Evaluation of a Screening Approach for Sexual Dysfunction in AYA Patients With and Surviving Childhood Cancer
- Conditions
- SurvivorshipPediatric Cancer
- Interventions
- Behavioral: Sexual Function Screening Approach
- Registration Number
- NCT05524610
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 205
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Post-Implementation of Routine Sexual Function Screening Sexual Function Screening Approach 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.
- Primary Outcome Measures
Name Time Method Comparison of sexual function communication before and after intervention implementation 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 Outcome Measures
Name Time Method Comparison of patient satisfaction before and after intervention implementation 5 years 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.
Adoption of the screening tool by medical stakeholders (self-reported results review) 5 years 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
Patient-reported feasibility of the sexual function screening approach 5 years Patients will complete a study-specific feasibility survey consisting of several questions on a 5-point scale (0=low feasibility, 5=high feasibility)
Provider-reported feasibility of the sexual function screening approach 5 years 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)
Evaluate implementation of the standardized screening approach by fidelity (patient-reported) 5 years Patients will respond regarding whether or not they experienced key components (Fidelity Checklist) of the intervention.
Comparison of healthcare needs being met before and after intervention implementation 5 years 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. .
Reach - proportion of eligible patients who completed sexual function screening 5 years Record abstraction evaluating the proportion of eligible patients who completed sexual function screening
Representativeness - sociodemographic characteristics of patients who received and did not receive screening 5 years Comparison of sociodemographic characteristics between eligible patients who did versus did not receive sexual function screening.
Adoption of the screening tool by medical stakeholders (self-reported results discussion) 5 years 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
Patient-reported acceptability of the sexual function screening approach 5 years Patients will complete a study-specific acceptability survey consisting of several questions on a 5-point scale (0=low acceptability, 5=high acceptability)
Provider-reported acceptability of the sexual function screening approach 5 years 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)
Patient-reported appropriateness of the sexual function screening approach 5 years Patients will complete a study-specific appropriateness survey consisting of several questions on a 5-point scale (0=low acceptability, 5=high acceptability)
Provider-reported appropriateness of the sexual function screening approach 5 years 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)
Evaluate implementation of the standardized screening approach by fidelity (direct observation) 5 years The study team will evaluate whether key components of the intervention (Fidelity Checklist) are completed via direct observation in 10% of patients across sites.
Contextual factors influencing implementation success 5 years Qualitative description of themes, barriers and facilitators to implementation will be determined via interviews with medical providers after completion of patient enrollment.
Trial Locations
- Locations (2)
Childrens Hospital Colorado
🇺🇸Aurora, Colorado, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States