- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04066218
Sexual Function Screening in Childhood Cancer Survivors
June 29, 2022 updated by: University of Colorado, Denver
Assessing Patient Preferences and a Clinical Tool for Evaluating for Sexual Function in Adolescent and Young Adult Survivors of Childhood Cancer
This is a qualitative research study involving semistructured interviews and Think-Aloud methodology during completion of a clinical screening tool.
All participants will undergo the same semistructured interviews.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The proposed research will explore patient-centered approaches to evaluating younger Adolescent/young adult Childhood cancer survivors for sexual dysfunction, including strategies for implementation and usability of thePatient-Reported Outcomes Measurement Information® v2.0 Brief Profile for Sexual Function and Satisfaction Brief, an existing adult screening tool.
This study will include interviews with 24 patients age 15-24 who were diagnosed with cancer prior to age 18, and treated with chemotherapy, radiation and/or surgery and are now at least two years off therapy.
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Aurora, Colorado, United States, 80045
- Colorado School of Public Health, University of Colorado Denver
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Sample size
- Max number of participants that can be enrolled is 30
- Max number of participants that can be interviewed is 24
- Gender Male and Female
- Age Range 15-24
- Demographic group English-speaking
- General health status Pediatric cancer survivors (diagnosed at <18 years of age and now at least 2 years off therapy)
- Geographic location Children's Hospital Colorado and University of Colorado Hospital
Description
Inclusion Criteria:
- Ability to read and understand the postcard consent.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Age 15-24 at time of enrollment
- History of cancer diagnosis, diagnosed at <18 years old
- Off therapy (chemotherapy, surgery, radiation) for a minimum of 2 years
- Sufficient cognitive functioning such that participants are able to complete study measures, as determined by their physician and research personnel.
Exclusion Criteria:
- Developmental or intellectual disability, as determined by the patient's physician
- Received neither chemotherapy nor radiation therapy
- Non-English speaking
- Non-English reading
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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age 15-19
The investigators plan to complete 24 interviews with 12 in the age 15-19 cohort.The investigators will also ensure that at least 8 people from each sex are included in this study.
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age 20-24
The investigators plan to complete 24 interviews with 12 in the age 20-24 cohort.
The investigators will also ensure that at least 8 people from each sex are included in this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describe AYA CCS perspectives on implementation of screening for sexual dysfunction, including preferred modality, setting and timing for evaluating sexual dysfunction.
Time Frame: 1 year
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Qualitative interviews will be conducted by phone by a trained qualitative research interviewer.
Interviews will be in-depth and semistructured, utilizing a combination of broad, open-ended questions and more specific probes.
The interview guide was developed with the help of Dr. Michael Fisher, PhD, who has expertise in qualitative research methodology.
The interviewer will take detailed field notes.
This portion of the interview will last approximately 25-35 minutes and will be digitally recorded and professionally transcribed.
After each interview, the interviewer will complete an Interview Summary Form, which will serve as a memoing tool and summarize initial themes or impressions that may be relevant to the research question.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess AYA CCS perceptions of the PROMIS SexFS Brief, an existing adult clinical screening tool for sexual dysfunction, in a qualitative pilot study.
Time Frame: 1 year
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Participants will be asked to evaluate the PROMIS SexFS Brief, which will be emailed to them at the time of the interview via a unique/secure REDCap link.
Participants will be given a choice of which version of the tool they complete (male or female).
Participants will be asked to complete the PROMIS SexFS Brief via REDCap while completing Think-Aloud methodology.
Via Think-Aloud, participants will be asked to verbalize their thoughts as they proceed through the task, which asks participants to verbalize their thoughts, without probing or additional explanations, as they undertake a task such as completing a clinical screening questionnaire.
In accordance with recommendations for conducting Think-Aloud, participants will participate in a warm-up exercise unrelated to sexual dysfunction prior to completing Think-Aloud.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2019
Primary Completion (Actual)
April 7, 2020
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
August 21, 2019
First Submitted That Met QC Criteria
August 21, 2019
First Posted (Actual)
August 26, 2019
Study Record Updates
Last Update Posted (Actual)
June 30, 2022
Last Update Submitted That Met QC Criteria
June 29, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 19-1111.cc
- P30CA046934 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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