Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06897137

Conditions

Malignant Solid Neoplasm

Hematopoietic Neoplasms

Lymphatic System Neoplasm

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

Interventions

Surveys/Questionnaires

Study Details

Brief summary:

This study evaluates how adolescent and young adults with cancer in the U.S. and their loved ones respond to questions that will later be used with people who may have cancer and other chronic health conditions

Conditions

Malignant Solid Neoplasm

Hematopoietic Neoplasms

Lymphatic System Neoplasm

Study ID

NCT06897137

Start date

Apr 26, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

AYAs with a cancer history (AYA-C)

Inclusion Criteria:

  • Young adults between the ages of 15 to 39 years;
  • First diagnosed with cancer during 15 to 39 years of age;
  • Able to read and understand English;
  • Live in the United States;
  • Have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 10 years post-treatment.

Exclusion Criteria:

  • Diagnosed with basal cell skin cancer; or
  • Are currently receiving hospice care.

AYAs General Population (AYA-GP)

Inclusion Criteria:

  • Young adults between the ages of 15 to 39 years;
  • Able to read and understand English; and
  • Live in the United States.

Caregivers of AYAs with cancer (AYA-Cg)

Inclusion Criteria:

  • 18 years of age or older;
  • Able to read and understand English;
  • Live in the United States;
  • Have a child/ward/partner for whom they have provided care, AND
  • Their child/ward/partner is 15 to 25 years of age and meets the other eligibility criteria as an AYA participant with a cancer history (described above).

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Participants will complete self-report questionnaires via Redcap. The questionnaires should take less than 30 minutes

Interventions

Surveys/Questionnaires

Participants will complete self-report questionnaires via Redcap. The questionnaires should take less than 30 minutes and will include the following options based on their relevance to each sample: 1) sociodemographic (including the comorbidity index) and clinical information, 2) newly developed item pools for body image, fertility, and financial burden, 3) legacy measures for body image, fertility, and financial burden, 4) the PROMIS AYA Health Status Profile, and 5) the PROMIS Global.

Primary outcome measure

  • Refining of Item Pools - Development of Four Item Banks [ Time Frame: Up to study completion, up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Stephanie Bunch

3367165180sbunch@wakehealth.edu

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Stephanie Bunch

336-716-5180sbunch@wakehealth.edu

Principal Investigator:

John M Salsman, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-30.