OCRA Distress & Unmet Needs

Identifying And Addressing Distress And Unmet Needs Of Gynecologic Cancer Caregivers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Other: Surveys

Detailed Description

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:

1. To measure distress and define the NMDOH needs of caregivers of patients with gynecologic cancers
2. To address unmet needs of gynecologic cancer caregivers through a semi-automated system to navigate caregivers to NMDOH and caregiving resources
3. To evaluate changes over time in caregivers' unmet needs and distress following receipt of a semi-automated, targeted caregiver resource navigation (CRN) system, and to explore associations between changes in caregiver needs/distress and patients' cancer-related outcomes and distress.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail Smith Zamorano, MD; Phone Number: 713-792-9938; Email: aszamorano@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • UT MD Anderson
      • Contact: Abigail Smith Zamorano, MD; Phone Number: 713-792-9938; Email: aszamorano@mdanderson.org
      • Principal Investigator: Abigail Smith Zamorano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

This study will include participants from two categories:

Patients:

1. Must be at least 18 years old
2. Must read and speak English or Spanish
3. Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator.
4. Patient presenting for initial or recurrence chemotherapy treatment for management of a gynecologic malignancy (cancer of the ovary, uterus, cervix, vulva, vagina, peritoneum, or fallopian tube)
5. No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement

Caregivers:

1. Must be at least 18 years old
2. Must read and speak English or Spanish
3. Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator.
4. Must be an identified caregiver of an enrolled patient
5. No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Other: Surveys; 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.
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.	Other: Surveys; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Ovarian Cancer Research Alliance (OCRA)
• Investigators: Principal Investigator: Abigail Smith Zamorano, MD, UT MD Anderson

Publications and helpful links

Helpful Links

• UT MD Anderson Website

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 2026-0036; NCI-2026-02643 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No