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Sexual Dysfunction Screening for Pediatric Cancer Survivors

N/A

Recruiting

Led By Jenna Demedis

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial found that the SexFS Brief, a tool to help identify sexual dysfunction in young cancer survivors, was acceptable to both patients and providers.

Who is the study for?

This trial is for young individuals aged 15-24 who have had or are currently dealing with childhood cancer, diagnosed before age 18. They must be able to consent, follow the study plan, and visit one of four specific clinics. Excluded are those unable to read/speak English, without cancer-directed therapy like chemo or surgery, cognitively impaired as judged by a clinician, at end-of-life care or already in hospice.

What is being tested?

The trial is testing a new way to screen for sexual dysfunction (SD) in adolescent and young adult-aged survivors of childhood cancer. It aims to find an effective method that's easy to use and helps doctors recognize SD issues better in these patients.

What are the potential side effects?

Since this trial involves a screening approach rather than medication or invasive procedures, there aren't typical side effects associated with drugs or surgeries. However, discussing sensitive topics like sexual function may cause emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of sexual function communication before and after intervention implementation

Secondary study objectives

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

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

Comparison of healthcare needs being met before and after intervention implementation

+12 more

Other study objectives

Adaptations to the sexual function screening approach

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

Incidence of documented sexual function concerns

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Post-Implementation of Routine Sexual Function ScreeningExperimental Treatment1 Intervention

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.

Group II: Pre-Implementation of Routine Sexual Function Screening (Baseline)Active Control1 Intervention

This arm will include patients with and surviving cancer who are seen during the Pre-Implementation study period. 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 pre-implementation survey will assess sexual function communication and patient satisfaction. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected.

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