Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07591623

OCRA Distress & Unmet Needs

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT MD Anderson

Houston, Texas, 77030, United States

Location contact

Abigail Smith Zamorano, MD

CONTACT

[email protected]

713-792-9938

Abigail Smith Zamorano, MD

PRINCIPAL_INVESTIGATOR

About this study

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:

  • To measure distress and define the NMDOH needs of caregivers of patients with gynecologic cancers
  • To address unmet needs of gynecologic cancer caregivers through a semi-automated system to navigate caregivers to NMDOH and caregiving resources
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Unwilling or unable to proceed beyond the consent statement step Caregivers
  • Unwilling or unable to proceed beyond the consent statement step

Treatment and study plan

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.

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Smith Zamorano, MD

CONTACT

[email protected]

713-792-9938

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Ovarian Cancer Research Alliance (OCRA)

Registry information

Official study title

Identifying And Addressing Distress And Unmet Needs Of Gynecologic Cancer Caregivers

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.