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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Sexual Function Screening Approach, SexFS Brief, Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) Brief v2.0 for pediatric cancer survivors?

The PROMIS SexFS Brief v2.0 has been shown to be an acceptable and useful tool for screening sexual dysfunction in adolescent and young adult childhood cancer survivors, helping to reduce barriers like discomfort and lack of knowledge. It has demonstrated validity and may improve the detection and diagnosis of sexual dysfunction in this population. ^{1 2 3 4 5}

Is the Sexual Function Screening Approach safe for pediatric cancer survivors?

The Sexual Function Screening Approach, including the PROMIS Sexual Function and Satisfaction (SexFS) Brief, has been evaluated for acceptability and usefulness among adolescent and young adult childhood cancer survivors, with no safety concerns reported in the studies. ^{1 2 3 4 6}

How does the PROMIS SexFS Brief treatment differ from other treatments for sexual dysfunction in 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, helping to screen and diagnose sexual dysfunction by reducing barriers like discomfort and lack of knowledge. ^{1 2 3 4 5}

Research Team

Jenna Demedis

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Development and Initial Validation of the PROMIS(®) Sexual Function and Satisfaction Measures Version 2.0. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Using cognitive interviews to evaluate items for measuring sexual functioning across cancer populations: improvements and remaining challenges. [2021]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Sexual Function Among Young Adult Cancer Survivors. [2023]