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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-02643 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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| Name | Class |
|---|---|
| Ovarian Cancer Research Alliance (OCRA) | UNKNOWN |
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This study is a prospective longitudinal cohort study with an embedded intervention. It follows participants with gynecologic malignancies and their informal caregivers over a 6-month period to assess caregiver distress, NMDOH, and patient outcomes.
Primary Objectives:
Caregivers of patients with gynecologic cancers are at risk for significant distress, which is further impacted by NMDOH. Although caregiver distress affects patient outcomes, it is not routinely measured or addressed in the clinical setting, and little is known about disparities in caregivers' distress and burden in a diverse gynecologic cancer population.
We, therefore, propose the following objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Caregiver | Experimental | This arm includes participants with gynecologic malignancies who identify and enroll with a caregiver. Both participants and caregivers will complete baseline, 3-month, and 6-month assessments. Caregiver distress and NMDOH needs will be evaluated at baseline, and results will be used to guide the provision of Community Resource Navigation (CRN). |
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| Patient Without a Caregivers | Experimental | This arm includes patients with gynecologic malignancies who do not identify or enroll with a caregiver. These participants will complete the same assessment timepoints (baseline, 3 months, and 6 months). Data from this group will serve as a comparison to evaluate differences in outcomes relative to patients with caregivers, including the impact of caregiver presence, distress levels, and NMDOH burden. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys | Other | Study surveys will be administered primarily in REDCap, or with the help of a coordinator (i.e. mailing surveys, over the phone, or with a tablet during clinic visits) if assistance is needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Adverse Events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year |
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Inclusion Criteria:
This study will include participants from two categories:
Patients:
Caregivers:
The study will include patients with no caregiver, and only one caregiver may enroll per patient.
Exclusion Criteria:
Patients:
1. Unwilling or unable to proceed beyond the consent statement step Caregivers
1. Unwilling or unable to proceed beyond the consent statement step
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abigail Smith Zamorano, MD | Contact | 713-792-9938 | aszamorano@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Abigail Smith Zamorano, MD | UT MD Anderson | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| UT MD Anderson Website | View source |
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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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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |