Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05524610

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pediatric Cancer Neoplasms Survivorship

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital Colorado, Aurora, Colorado, United States

Loading trial locations.

About this study

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. A subset of patients will also undergo qualitative interviews after consent to this additional study procedure. After effectiveness data collection is complete, implementation outcomes will also be assessed via surveys and interviews with consenting provider stakeholders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • 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)
  • 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.
  • Cancer must have been diagnosed before the age of 18 years
  • 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:

  • 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
  • Patient is at end of life or on hospice, as determined by primary oncologist
  • Patients who did not undergo sexual function screening within 1 month of being due will be excluded from implementation outcomes measurement
  • Patient is at end of life or on hospice, as determined by primary oncologist

Treatment and study plan

Sexual Function Screening Approach

Behavioral

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.

Other names: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) Sexual Function and Satisfaction (SexFS) Brief v2.0 tool

Primary outcomes

  1. Comparison of sexual function communication before and after intervention implementation

    Time frame: 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 outcomes

  1. Comparison of patient satisfaction before and after intervention implementation

    Time frame: 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.

  2. Comparison of healthcare needs being met before and after intervention implementation

    Time frame: 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. .

  3. Reach - proportion of eligible patients who completed sexual function screening

    Time frame: 5 years

    Record abstraction evaluating the proportion of eligible patients who completed sexual function screening

  4. Representativeness - sociodemographic characteristics of patients who received and did not receive screening

    Time frame: 5 years

    Comparison of sociodemographic characteristics between eligible patients who did versus did not receive sexual function screening.

  5. Adoption of the screening tool by medical stakeholders (self-reported results review)

    Time frame: 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

  6. Adoption of the screening tool by medical stakeholders (self-reported results discussion)

    Time frame: 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

  7. Patient-reported acceptability of the sexual function screening approach

    Time frame: 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). A subset of patients will also undergo qualitative interviews to further explore this outcome.

  8. Provider-reported acceptability of the sexual function screening approach

    Time frame: 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)

  9. Patient-reported appropriateness of the sexual function screening approach

    Time frame: 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). A subset of patients will also undergo qualitative interviews to further explore this outcome.

  10. Provider-reported appropriateness of the sexual function screening approach

    Time frame: 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)

  11. Patient-reported feasibility of the sexual function screening approach

    Time frame: 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). A subset of patients will also undergo qualitative interviews to further explore this outcome.

  12. Provider-reported feasibility of the sexual function screening approach

    Time frame: 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)

  13. Evaluate implementation of the standardized screening approach by fidelity (patient-reported)

    Time frame: 5 years

    Patients will respond regarding whether or not they experienced key components (Fidelity Checklist) of the intervention.

  14. Evaluate implementation of the standardized screening approach by fidelity (direct observation)

    Time frame: 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.

  15. Contextual factors influencing implementation success

    Time frame: 5 years

    Qualitative description of themes, barriers and facilitators to implementation will be determined via interviews with medical providers after completion of patient enrollment.

Other outcomes

  1. Referral patterns for sexual function concerns

    Time frame: 5 years

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

  2. Incidence of documented sexual function concerns

    Time frame: 5 years

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

  3. Adoption, as measured by proportion of results that are viewed (objective measure)

    Time frame: 5 years

    Proportion of answered sexual function screening surveys that show evidence of having been viewed (i.e. electronic health record (EHR) clicks)

  4. Reach - Reason for missed screening

    Time frame: 5 years

    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. Adaptations to the sexual function screening approach

    Time frame: 5 years

    Qualitative description of documented adaptations to the screening approach as they occur throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Shepperd

CONTACT

[email protected]

7207776819

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Stakeholder-Engaged Development and Evaluation of a Screening Approach for Sexual Dysfunction in Adolescent and Young Adult Patients With and Surviving Childhood Cancer

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.