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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Sexual Function Screening Approach

    Behavioral

    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.

Treatment groups

205 Participants
are divided into 2 treatment groups
Group A: Pre-Implementation of Routine Sexual Function Screening (Baseline)No intervention 0 interventions
Group B: Post-Implementation of Routine Sexual Function ScreeningExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

Referral patterns for sexual function concerns

Comparison the referral patterns before and after implementation of the sexual function screening approach (exploratory)

Time frame
5 years
2

Incidence of documented sexual function concerns

Comparison the documentation about sexual function concerns before and after implementation of the sexual function screening approach (exploratory)

Time frame
5 years
3

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)

Time frame
5 years
4

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

Time frame
5 years

Sponsors and contacts

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University of Colorado, Denver

Lead sponsor

National Cancer Institute (NCI)

Collaborator