Sexual Dysfunction Screening for Pediatric Cancer Survivors
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
Disqualifiers: Non-English, No cancer therapy, Cognitive impairment, others
No Placebo Group
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.
12345Is 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.
12346How 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.
12345Eligibility 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.
+3 more
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.
+3 more
Trial 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Childrens Hospital ColoradoAurora, CO
University of Colorado HospitalAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
National Institutes of Health (NIH)Collaborator
National Cancer Institute (NCI)Collaborator
References
Evaluation of the v2.0 Brief Profiles for Sexual Function and Satisfaction PROMIS in Adolescent and Young Adult Childhood Cancer Survivors. [2021]Purpose: Sexual dysfunction (SD) is a common, but often unrecognized potential late effect among childhood cancer survivors (CCS). Unfortunately, both patients and providers report low levels of routine screening and identify multiple barriers, including lack of knowledge, discomfort, and limited time. This is particularly true among CCS who are adolescent or young adult aged (AYA-CCS). One potential way to increase screening, detection, and treatment for SD among AYA-CCS is to employ patient-reported outcomes measures. While adult screening tools exist, no SD screening tool has been evaluated specifically among this younger population. Methods: This qualitative study used Think-Aloud and cognitive interviewing methods to obtain feedback from AYA-CCS on acceptability, usefulness, and validity of the Patient-Reported Outcomes Measurement Information System® (PROMIS®) v2.0 Brief Profiles for Sexual Function and Satisfaction (SexFS Brief) in CCS now 15-24 years of age. Results: The SexFS Brief demonstrated acceptability, response process and content validity, and usefulness among AYA-CCS. There were no detectable differences by age or gender. This study did not reveal any necessary modification to the SexFS Brief for this population. Conclusion: The PROMIS SexFS Brief is an acceptable and useful tool, with demonstrated response process and content validity, and may facilitate improved screening and diagnosis of SD among AYA-CCS. Furthermore, this tool was viewed favorably by AYA-CCS as a way to reduce barriers such as discomfort and lack of knowledge on the part of patients. Further evaluation of its effectiveness and acceptability in a clinical setting is warranted.
Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer. [2021]We describe the development and validation of the Patient-Reported Outcomes Measurement Information System(®) Sexual Function and Satisfaction (PROMIS(®) SexFS; National Institutes of Health) measures, version 1.0, for cancer populations.
Development and Initial Validation of the PROMIS(®) Sexual Function and Satisfaction Measures Version 2.0. [2019]The Patient-Reported Outcomes Measurement Information System (PROMIS)(®) Sexual Function and Satisfaction measure (SexFS) version 1.0 was developed with cancer populations. There is a need to expand the SexFS and provide evidence of its validity in diverse populations.
Using cognitive interviews to evaluate items for measuring sexual functioning across cancer populations: improvements and remaining challenges. [2021]One goal of the Patient-Reported Outcomes Measurement Information System (PROMIS) is to develop a measure of sexual functioning that broadens the definition of sexual activity and incorporates items that reflect constructs identified as important by patients with cancer. We describe how cognitive interviews improved the quality of the items and discuss remaining challenges to assessing sexual functioning in research with cancer populations.
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]An area of concern affecting the quality of life of childhood cancer survivors (CCS) is that of sexual dysfunction (SD), which may be a result of both physical and psychosexual challenges associated with cancer and its treatment. This is especially pertinent as CCS are known to experience diminished quality of life compared to peers. Relevant to SD, cancer and its associated treatment are associated with negative effects on body image and romantic relationships, as well as overall physical and mental health. Although CCS have been shown to have SD at higher rates than the general population, this is often under-recognized and CCS commonly report that it is not addressed by their health care providers. To guide future research and improve clinical screening and treatment practices for SD, we performed a narrative review of this understudied topic to summarize existing knowledge of the incidence, risk factors, pathophysiology, and rates of screening for SD in CCS. We also outline current gaps in knowledge and directions for future research.
Patient-Reported Sexual Function Among Young Adult Cancer Survivors. [2023]Purpose: Reproductive health and sexual function are important to survivors of Adolescent and Young adult (AYA) cancers. We evaluated the prevalence of sexual dysfunction and factors associated with dysfunction using the Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function (SexFS) measure in AYAs (15-39 years old at diagnosis) enrolled in a cancer survivorship cohort. Materials and Methods: Using a cross-sectional survey of a tertiary medical center-based cancer survivorship cohort, we determined the mean PROMIS SexFS v1.0 T-scores and prevalence of scores that were indicative of dysfunction (>1/2 standard deviation [SD] below reference population mean). Multivariable generalized linear regression was performed to identify factors associated with lower scores. Results: We identified 284 AYA cancer survivors, most of whom were women (70%). The mean age at survey was 36.0 years (SD = 7.9). Overall, 31% of females and 19% of men had clinically significantly lower scores than the general U.S. population in the domain of interest, and 13% of women and 6% of men had abnormal scores for satisfaction. Twenty-six percent of male AYAs reported erectile dysfunction. The rate of sexual inactivity in the last 30 days was 27%. Low levels of physical activity were associated with lower PROMIS scores for interest in sexual activity in both men and women, and for global satisfaction with sex life in women only. Conclusions: Our results suggest that low interest in sexual activity is common among survivors of AYA cancers. Low levels of physical activity may be associated with lower levels of interest in and satisfaction with sexual activity in this population.