Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology
NCT ID: NCT06897137
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
3000 participants
OBSERVATIONAL
2026-01-31
2028-01-31
Brief Summary
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Detailed Description
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* To refine patient-reported outcome assessment tools of body image, fertility, and financial burden for PROMIS and evaluate assumptions for IRT consistent with PROMIS Scientific Standards (e.g., unidimensionality, local independence).
* To examine item-level properties to support computer adaptive testing and evaluate possible differential item functioning (DIF).
Secondary Objective
* To create short forms and examine convergent validity of the new body image, fertility, and financial burden short forms and item banks with corresponding legacy measures of those constructs.
OUTLINE: This is an observational study.
Participants complete surveys on study.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Observational
Participants will complete self-report questionnaires via Redcap. The questionnaires should take less than 30 minutes
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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)
* 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).
Exclusion Criteria
* Are currently receiving hospice care.
AYAs General Population (AYA-GP)
15 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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John Salsman
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Comprehensive Cancer Center
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Stephanie Bunch
Role: primary
Other Identifiers
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IRB00134827
Identifier Type: -
Identifier Source: org_study_id