Sexual Function Screening in Childhood Cancer Survivors

NCT ID: NCT04066218

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2022-06-01

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.

Conditions

Childhood Cancer; Survivorship; Sexual Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Interviews

Intervention Type: OTHER

• 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.

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.

Interviews

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Colorado School of Public Health, University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-1111.cc

Identifier Type: -

Identifier Source: org_study_id