OCRA Distress & Unmet Needs

Official title

Identifying And Addressing Distress And Unmet Needs Of Gynecologic Cancer Caregivers

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• UT MD Anderson — Houston

Identifiers

NCT: NCT07591623 · 2026-0036 · NCI-2026-02643

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗