OCRA Distress & Unmet Needs

NCT07591623 | Not Yet Recruiting DMC

• 2 other identifiers: 2026-0036NCI-2026-02643
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

Other: Surveys

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.

Other: Surveys

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.

Patient Without a Caregivers; Patient-Caregiver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study will include participants from two categories:
• Patients:
• Must be at least 18 years old
• Must read and speak English or Spanish
• 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.
• 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)
• No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement
• Caregivers:
• Must be at least 18 years old
• Must read and speak English or Spanish
• 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.
• Must be an identified caregiver of an enrolled patient
• 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.

You may not qualify if:

• Patients:
• \. Unwilling or unable to proceed beyond the consent statement step Caregivers
• \. Unwilling or unable to proceed beyond the consent statement step

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Ovarian Cancer Research Alliance (OCRA): collaborator

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Abigail Smith Zamorano, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Smith Zamorano, MD

CONTACT

713-792-9938; aszamorano@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (1)