Comprehensive Care for AYA: Needs Assessment Survey

NCT07196241 | Recruiting DMC

• 2 other identifiers: IRB00136539ONC-CCS-2505
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to assess gaps in education about exercise, sexual health, fertility, survivorship, financial issues, interpersonal relationships, and clinical trial participation among adolescents and young adults with cancer. Participants will be asked to complete a series of questionnaires.

Conditions

Cancer; Young Adult Cancer; Adolescent Cancer

Keywords

Adolescent; Young Adult; Cancer; AYA; Questionnaire; Needs assessment

Outcome Measures

Primary Outcomes (2)

• Deficits in Education

  The general information survey collects data on participants surrounding education on health-related topics, gender, and sexual orientation, as well as perceived needs for resources, support areas, programs and activities. The general information survey contains 12 items. There is no formal statistical analysis to be performed only summary statistics on completed survey items for observation thus there is no scoring needed or range of scores. Results will be observed using descriptive statistics. Due to the categorical nature of all variables, results will be reported in frequencies and percentages.

  At study enrollment

• Preferred Format for Education

  The General Information Survey collects data on participants surrounding education on health-related topics, gender, and sexual orientation, as well as perceived needs for resources, support areas, programs and activities. The general information survey contains 12 items. There is no formal statistical analysis to be performed only summary statistics on completed survey items for observation thus there is no scoring needed or range of scores. Results will be observed using descriptive statistics. Due to the categorical nature of all variables, results will be reported in frequencies and percentages.

  At study enrollment

Other Outcomes (2)

• Deficit in Education by Covariates

  At study enrollment

• Focus Group Interest

  At study enrollment

Study Arms (1)

Adolescents and Young Adults with cancer

Participants diagnosed with cancer between the ages of 15-39 who have received or are receiving cancer-directed treatment at one of the participating centers per self-report.

Other: Survey using a questionnaire.

Interventions

Survey using a questionnaire. OTHER

Questionnaires regarding cancer treatment and follow-up care, fertility preservation, clinical trial participation, general information (education on health- related topics, gender, and sexual orientation, perceived needs for resources, support areas, programs and activities.), emotional health and interpersonal relationships, financial burden and mental health status.

Adolescents and Young Adults with cancer

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants diagnosed with cancer between the ages of 15 and 39 and who received or are receiving treatment for their cancer at one of the centers participating in this research study.

You may qualify if:

• Individuals diagnosed with cancer between the ages of 15-39 per self-report. Participants may be enrolled at any age provided diagnosis was between ages 15-39.
• Individuals who have received or are receiving cancer-directed treatment (chemotherapy, immunotherapy, surgery and/or radiation) at one of the participating centers per self-report.

You may not qualify if:

• Severe emotional distress or anxiety that would limit compliance with study requirements per self-report.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Wake Forest Baptist: collaborator

Study Sites (2)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Anne Wofford, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Wofford, MD

CONTACT

336-716-3684; anne.wofford@advocatehealth.org

Study Design

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

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)