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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of sexual function communication before and after intervention implementation
Secondary outcome measures
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 moreOther outcome measures
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 moreTrial 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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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,671 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,321 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,649 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 15 and 24 years old.My cognitive abilities are sufficient to participate in study activities.I was diagnosed with cancer before 18 and received treatment like chemotherapy, radiotherapy, or surgery.I have or had cancer that is aggressive or has spread.I have not undergone any treatment specifically for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Post-Implementation of Routine Sexual Function Screening
- Group 2: Pre-Implementation of Routine Sexual Function Screening (Baseline)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial have any vacancies for participants at present?
"As indicated by the clinicaltrials.gov database, this particular medical trial has ceased its recruitment phase as of August 29th 2022. Initially posted on December 1st 2022, this study is no longer open for new enrolment; however, there are 97 other studies actively seeking participants at present."
Answered by AI
Do the eligibility requirements of this experiment extend to those over 50 years old?
"Patients aged 15 and above, but below 24 years old are considered eligible for this medical study."
Answered by AI
Does my medical history qualify me to partake in this experiment?
"This clinical trial, which is welcoming 205 participants in total, requires that all applicants have pediatric cancer and are between the ages of 15 to 24."
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