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Sexual Function Screening in Childhood Cancer Survivors

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 : Active, not recruiting
First Posted : August 26, 2019
Last Update Posted : April 23, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date August 21, 2019
First Posted Date August 26, 2019
Last Update Posted Date April 23, 2021
Actual Study Start Date September 16, 2019
Actual Primary Completion Date April 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 21, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sexual Function Screening in Childhood Cancer Survivors
Official Title Assessing Patient Preferences and a Clinical Tool for Evaluating for Sexual Function in Adolescent and Young Adult Survivors of Childhood Cancer
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Childhood Cancer
  • Survivorship
  • Sexual Dysfunction
Intervention Other: Interviews
  • Participation will serve as verbal consent.
  • Qualitative PRA will call participant to schedule either phone or in person interview. If via phone, the study PRA performing the interview, will remind them to find a private space to speak.
  • REDCap link will be sent for PROMIS SexFS Brief.
  • PRA will perform semistructured interview and guide Think-Aloud to complete the PROMIS SexFS Brief.
  • Participants will not submit responses to PROMIS SexFS Brief responses after completing the tool.
Study Groups/Cohorts
  • 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.
    Intervention: Other: Interviews
  • 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.
    Intervention: Other: Interviews
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 10, 2020)
24
Original Estimated Enrollment
 (submitted: August 21, 2019)
30
Estimated Study Completion Date June 1, 2022
Actual Primary Completion Date April 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Ability to read and understand the postcard consent.
  2. Stated willingness to comply with all study procedures and be available for the duration of the study.
  3. Age 15-24 at time of enrollment
  4. History of cancer diagnosis, diagnosed at <18 years old
  5. Off therapy (chemotherapy, surgery, radiation) for a minimum of 2 years
  6. Sufficient cognitive functioning such that participants are able to complete study measures, as determined by their physician and research personnel.

Exclusion Criteria:

  1. Developmental or intellectual disability, as determined by the patient's physician
  2. Received neither chemotherapy nor radiation therapy
  3. Non-English speaking
  4. Non-English reading
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04066218
Other Study ID Numbers 19-1111.cc
P30CA046934 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators National Cancer Institute (NCI)
Investigators Not Provided
PRS Account University of Colorado, Denver
Verification Date April 2021