Sexual Function Screening in Childhood Cancer Survivors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04066218 |
Recruitment Status :
Completed
First Posted : August 26, 2019
Last Update Posted : June 30, 2022
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Condition or disease | Intervention/treatment |
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Childhood Cancer Survivorship Sexual Dysfunction | Other: Interviews |
Study Type : | Observational |
Actual Enrollment : | 24 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Assessing Patient Preferences and a Clinical Tool for Evaluating for Sexual Function in Adolescent and Young Adult Survivors of Childhood Cancer |
Actual Study Start Date : | September 16, 2019 |
Actual Primary Completion Date : | April 7, 2020 |
Actual Study Completion Date : | June 1, 2022 |
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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Other: Interviews
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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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Other: Interviews
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- 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 ]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.
- 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 ]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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Ages Eligible for Study: | 15 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066218
United States, Colorado | |
Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 | |
Colorado School of Public Health, University of Colorado Denver | |
Aurora, Colorado, United States, 80045 |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT04066218 |
Other Study ID Numbers: |
19-1111.cc P30CA046934 ( U.S. NIH Grant/Contract ) |
First Posted: | August 26, 2019 Key Record Dates |
Last Update Posted: | June 30, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |