Sexual Function Screening in Childhood Cancer Survivors

NCT04066218 | Completed

• 2 other identifiers: 19-1111.ccP30CA046934
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Childhood Cancer; Survivorship; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Describe AYA CCS perspectives on implementation of screening for sexual dysfunction, including preferred modality, setting and timing for evaluating sexual dysfunction.

  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.

  1 year

Secondary Outcomes (1)

• 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 Arms (2)

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.

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.

Other: Interviews

Interventions

Interviews 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 15-19; age 20-24

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Developmental or intellectual disability, as determined by the patient's physician
• Received neither chemotherapy nor radiation therapy
• Non-English speaking
• Non-English reading

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Colorado School of Public Health, University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Neoplasms; Sexual Dysfunction, Physiological

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: September 16, 2019
• Primary Completion: April 7, 2020
• Study Completion: June 1, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)