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Clinical Trials/NCT04066218
NCT04066218
Completed
N/A

Assessing Patient Preferences and a Clinical Tool for Evaluating for Sexual Function in Adolescent and Young Adult Survivors of Childhood Cancer

University of Colorado, Denver2 sites in 1 country24 target enrollmentSeptember 16, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Cancer
Sponsor
University of Colorado, Denver
Enrollment
24
Locations
2
Primary Endpoint
Describe AYA CCS perspectives on implementation of screening for sexual dysfunction, including preferred modality, setting and timing for evaluating sexual dysfunction.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2019
End Date
June 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Assess AYA CCS perceptions of the PROMIS SexFS Brief, an existing adult clinical screening tool for sexual dysfunction, in a qualitative pilot study.(1 year)

Study Sites (2)

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