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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA218398 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
PRIMARY OBJECTIVES:
Secondary Objective
OUTLINE: This is an observational study.
Participants complete surveys on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Participants will complete self-report questionnaires via Redcap. The questionnaires should take less than 30 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys/Questionnaires | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Refining of Item Pools - Development of Four Item Banks | Upon completion of data analysis and study team review, investigators will have four unidimensional and locally independent, calibrated item banks: three for AYAs (body image, fertility, and financial burden) and one for caregivers (financial burden). In order to successfully calibrate an item bank, an n=500 is required per bank. In order to examine differential item functioning (DIF), a minimum n=200 per group is recommended. Our proposed sample sizes and specific subgroup accrual targets will be needed to calibrate multiple new item banks (body image, fertility, financial burden), evaluate DIF for various categories (age, gender, race, education) within our sample subgroups (AYAs with and without cancer), and to conduct confirmatory factor analysis (CFAs) on the item banks. In addition, the AYA sample the general population will serve as our reference to establish the mean and standard deviation for body image and fertility. | Up to study completion, up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Development Based on Item Bank Data | After the body image, fertility, and financial burden item banks have been calibrated from the primary outcome, short forms will be assembled by selecting the most informative (i.e., high measurement precision with little measurement error) and discriminating items (i.e., item response therapy (IRT) slopes that describe how well an item discriminates among individuals at different points along the measurement continuum) from each of the calibrated item banks. The convergent validity of the new PROMIS item banks and short forms will be examined using bivariate Pearson correlations with comparable constructs. |
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AYAs with a cancer history (AYA-C)
Inclusion Criteria:
Exclusion Criteria:
AYAs General Population (AYA-GP)
Inclusion Criteria:
Caregivers of AYAs with cancer (AYA-Cg)
Inclusion Criteria:
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Adolescent young adults with and without cancer and caregivers of adolescent young adults with cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Bunch | Contact | 3367165180 | sbunch@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Salsman | Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Up to study completion, up to approximately 2 years |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |