Sexual Dysfunction Screening for Pediatric Cancer Survivors

Recruiting at 1 trial location

Overseen By Barbara Shepperd

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Non-English, No cancer therapy, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

205 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors recognize sexual dysfunction in young people who had cancer during childhood. The study will test a new screening method for sexual health issues, aiming to make discussions about sexual function more common and comfortable in medical settings. Participants will help researchers assess the effectiveness and user-friendliness of this new screening approach, known as the Sexual Function Screening Approach. The trial seeks participants aged 15-24 who were diagnosed with cancer before age 18 and have undergone treatment such as chemotherapy, radiotherapy, or surgery. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance future healthcare experiences for young cancer survivors.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this sexual function screening approach is safe for pediatric cancer survivors?

Research has shown that the Sexual Function Screening Approach, particularly the PROMIS SexFS Brief, serves as a reliable and effective tool. It measures sexual function and satisfaction based on self-reports from adolescent and young adult cancer survivors. Studies have found it well-received and useful for identifying sexual dysfunction, a common issue among childhood cancer survivors.

No evidence indicates any negative effects or safety concerns with this screening method. This suggests it is a safe and straightforward way to assess sexual health issues in this group. Designed to gather information directly from patients about their experiences, the tool generally poses low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve the way healthcare providers address sexual dysfunction in young cancer survivors, a topic often overlooked in standard care. Unlike current practices that may not consistently include sexual health discussions, this trial implements routine sexual function screenings, making it a regular part of the care process. By integrating these screenings, the trial seeks to enhance communication between patients and healthcare providers, ultimately leading to better patient satisfaction and more comprehensive care. Additionally, the trial will explore how feasible and appropriate this approach is, potentially setting a new standard for addressing sexual health in pediatric cancer survivorship.

What evidence suggests that this sexual function screening approach is effective for pediatric cancer survivors?

Research shows that the Sexual Function Screening method, studied in this trial, helps identify sexual problems in young cancer survivors. Past studies have found the PROMIS SexFS Brief, a component of this method, to be both acceptable and reliable. This trial includes pre-implementation and post-implementation arms to assess the impact of routine sexual function screening. Early results suggest that this tool improves communication about sexual health between young survivors and their healthcare providers, potentially addressing sexual health problems sooner and more effectively. ^{1 5 6 7 8}

Who Is on the Research Team?

Jenna Demedis

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 15 and 24 years old.

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

I was diagnosed with cancer before 18 and received treatment like chemotherapy, radiotherapy, or surgery.

Exclusion Criteria

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

My cognitive abilities are sufficient to participate in study activities.

Timeline for a Trial Participant

Screening Development

Integration of patient and provider feedback to refine a standardized sexual function screening approach

Not specified

Pre-Implementation

Collection of baseline data on sexual function screening and patient satisfaction through surveys and medical record review

Not specified

End of each visit

Implementation

Clinic-wide implementation of the sexual function screening intervention as standard of care

Not specified

End of each visit

Post-Implementation

Collection of post-implementation data on effectiveness and implementation outcomes via survey and EHR review

Not specified

End of each visit

Follow-up

Participants are monitored for effectiveness and implementation outcomes after intervention

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Sexual Function Screening Approach

Trial Overview

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.

How Is the Trial Designed?

Group I: Post-Implementation of Routine Sexual Function Screening Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The development of the PROMIS Sexual Function and Satisfaction measure (SexFS) version 2.0 involved extensive input from clinical experts and diverse patient focus groups, resulting in a comprehensive tool with 11 scored scales and 6 nonscored item pools that assess various aspects of sexual function and satisfaction.

Preliminary evidence supports the validity of SexFS v2.0 across different genders and sexual activity statuses, making it a customizable and relevant measure for diverse populations, with improvements over the previous version in terms of applicability and psychometric evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Initial Validation of the PROMIS(®) Sexual Function and Satisfaction Measures Version 2.0. Weinfurt, KP., Lin, L., Bruner, DW., et al.[2019]

The PROMIS Sexual Function and Satisfaction (SexFS) measures were developed through extensive research, including focus groups with 819 cancer patients, ensuring that the tool is both reliable and valid for assessing sexual function and satisfaction in cancer populations.

This customizable measure includes 81 items across 11 domains, demonstrating strong content and face validity, as well as good test-retest reliability, making it a valuable resource for researchers studying sexual health in diverse patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer. Flynn, KE., Lin, L., Cyranowski, JM., et al.[2021]

Cognitive interviews with 39 cancer patients and survivors significantly improved the quality of items for a new measure of sexual functioning, ensuring they reflect the experiences and needs of patients.

The process highlighted challenges in consistently measuring sexual functioning, emphasizing the importance of broad definitions and patient feedback in developing effective assessment tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using cognitive interviews to evaluate items for measuring sexual functioning across cancer populations: improvements and remaining challenges. Fortune-Greeley, AK., Flynn, KE., Jeffery, DD., et al.[2021]

Childhood cancer survivors (CCS) experience sexual dysfunction (SD) at higher rates than the general population, which negatively impacts their quality of life, body image, and romantic relationships.

Despite the prevalence of SD among CCS, it is often under-recognized and inadequately addressed by healthcare providers, highlighting the need for improved clinical screening and treatment practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Dysfunction in Adolescent and Young Adult Survivors of Childhood Cancer: Presentation, Risk Factors, and Evaluation of an Underdiagnosed Late Effect: A Narrative Review. Sopfe, J., Gupta, A., Appiah, LC., et al.[2021]

In a study of 284 adolescent and young adult cancer survivors, 31% of women and 19% of men reported significant sexual dysfunction compared to the general population, highlighting the impact of cancer on sexual health.

Low physical activity levels were linked to decreased interest in sexual activity and satisfaction, suggesting that promoting physical activity may help improve sexual function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Sexual Function Among Young Adult Cancer Survivors. Fitz, VW., Anderson, C., Manuck, TA., et al.[2023]

The PROMIS v2.0 Brief Profiles for Sexual Function and Satisfaction (SexFS Brief) is an acceptable and valid tool for screening sexual dysfunction in adolescent and young adult childhood cancer survivors (AYA-CCS), based on qualitative feedback from participants aged 15-24.

Using the SexFS Brief may help reduce barriers to screening for sexual dysfunction, such as discomfort and lack of knowledge, thereby improving detection and treatment among AYA-CCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the v2.0 Brief Profiles for Sexual Function and Satisfaction PROMIS in Adolescent and Young Adult Childhood Cancer Survivors. Sopfe, J., Marsh, R., Ziniel, SI., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33136468/

Evaluation of the v2.0 Brief Profiles for Sexual Function and ...

Results: The SexFS Brief demonstrated acceptability, response process and content validity, and usefulness among AYA-CCS. There were no detectable differences ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11178009/

Testing effectiveness and implementation of a standardized ...

This study will measure the effectiveness of a standardized SD screening intervention and assess implementation outcomes and multilevel barriers and ...

3.

researchgate.net

researchgate.net/publication/346584758_Evaluation_of_the_v20_Brief_Profiles_for_Sexual_Function_and_Satisfaction_PROMIS_in_Adolescent_and_Young_Adult_Childhood_Cancer_Survivors

Evaluation of the v2.0 Brief Profiles for Sexual Function and ...

Purpose: Sexual dysfunction (SD) is a common, but often unrecognized potential late effect among childhood cancer survivors (CCS).

4.

semanticscholar.org

semanticscholar.org/paper/Evaluation-of-the-v2.0-Brief-Profiles-for-Sexual-in-Sopfe-Marsh/17e5394f97d975b206bc2658a3896bda9d7c4d49

Evaluation of the v2.0 Brief Profiles for Sexual Function and ...

The PROMIS SexFS Brief is an acceptable and useful tool, with demonstrated response process and content validity, and may facilitate improved screening and ...

5.

careacross.com

careacross.com/clinical-trials/trial/NCT05524610

Development and Evaluation of a Screening Approach for ...

Description: The screening approach will consist of: 1. Standardized use of the PROMIS SexFS Brief in a clinic setting. This tool assesses sexual interest/ ...

6.

withpower.com

withpower.com/trial/phase-survival-rate-survivorship-11-2022-b574f

Sexual Dysfunction Screening for Pediatric Cancer Survivors

The PROMIS SexFS Brief is unique because it is a patient-reported outcomes tool specifically evaluated for adolescent and young adult childhood cancer survivors ...

7.

healthmeasures.net

healthmeasures.net/images/PROMIS/manuals/PROMIS_Sexual_Function_and_Satisfaction_Measures_User_Manual_v1.0_and_v2.0.pdf

PROMIS Sexual Function and Satisfaction Manual

About Sexual Function and Satisfaction​​ The PROMIS SexFS v2. 0 measures a range of sexual activities, symptoms, functioning, and evaluation of ...

8.

researchgate.net

researchgate.net/publication/255170815_Development_of_the_NIH_PROMIS_R_Sexual_Function_and_Satisfaction_Measures_in_Patients_with_Cancer

Development of the NIH PROMIS ® Sexual Function and ...

Conclusions: The PROMIS SexFS offers researchers a reliable and valid set of tools to measure self-reported sexual function and satisfaction ...