OCRA Distress & Unmet Needs

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07591623
Status
Not Yet Recruiting

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Conditions

  • Gynecologic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Patient-Caregiver
    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).
  • Experimental: Patient Without a Caregivers
    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.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Abigail Smith Zamorano, MD
[email protected]
713-792-9938
Abigail Smith Zamorano, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UT MD Anderson· Houston, TX

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