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: 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
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 intervention adaptation. The protocol will be amended as needed to include any relevant updates to the screening approach. Some components may vary per site.
Childrens Hospital Colorado
Aurora, Colorado, United States
RECRUITINGUniversity of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGComparison 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.
Time frame: 5 years
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.
Time frame: 5 years
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. .
Time frame: 5 years
Reach - proportion of eligible patients who completed sexual function screening
Record abstraction evaluating the 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
Comparison of sociodemographic characteristics between eligible patients who did versus did not receive sexual function screening.
Time frame: 5 years
Adoption of the screening tool by medical stakeholders (self-reported results review)
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Enrollment
205
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
Time frame: 5 years
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
Time frame: 5 years
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)
Time frame: 5 years
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)
Time frame: 5 years
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)
Time frame: 5 years
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)
Time frame: 5 years
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)
Time frame: 5 years
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)
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years