Survivorship Care for Women Living With Ovarian Cancer: (POSTCARE-O) (POSTCARE-O)

March 30, 2026 updated by: Elizabeth A Kvale, Baylor College of Medicine

POSTCARE-O: Survivorship Care for Women Living With Ovarian Cancer

This study will enroll 120 women living with ovarian cancer following completion of initial treatment. Our objective is to test an intervention designed to provide support during the survivorship transition for this population, who live with a high degree of morbidity related to the illness and its treatment as well as a high risk of recurrence. Study participants will be randomly assigned to receive survivorship care using the POSTCare-O process or usual care. The primary outcome is quality of life at 12 weeks after intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design We will conduct a 2-arm randomized controlled trial to evaluate the impact of a telehealth delivered survivorship transition care process. Ovarian cancer survivors (120) will be randomly allocated to receive survivorship care either using the POSTCare Process or standard of care. Study design and reporting will be in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist. We will use quantitative and qualitative methodologies in a concurrent triangulation mixed methods design utilizing qualitative data to augment our interpretation of quantitative data. Outcomes will be collected at baseline, 12 weeks and 24 weeks, with the primary outcome being quality of life assessment at 12 weeks.

Sample Size We will enroll 120 women completing primary treatment for Stage 2-4 ovarian cancer from 3 urban gynecologic oncology clinics located in the Southern United States. Participants will have received some combination of surgery, chemotherapy, radiation therapy, and biologics. Continued maintenance therapy is not an exclusion factor. Aim 1 proposes to implement a randomized controlled trial (RCT) devised to compare QOL measures among ovarian cancer patient randomized to receive usual care versus the POSTCare survivorship care transition program. The Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QOL survey will be collected at baseline as well as 12 and 24 weeks after the initial course of adjuvant chemotherapy. The primary endpoint will be the 12-week survey. We expect to observe a mean 12-week FACT-O score of 116 with standard deviation of 20 for women receiving usual care. The sample size of N=120 patients provides at least 80% power to detect a 7% increase in the mean FACT-O score for women randomized to the POSTCare survivorship care intervention. This is sufficient to ascertain a minimally important difference of 8 points.

Recruitment and Setting We will recruit participants from Gynecologic Oncology practices at 3 clinic settings in Texas: One safety net practice located in Dallas, one safety net practice located in Houston, and one faculty group practice located in Houston. Cumulatively the sites serve approximately 120 eligible patients per year and ensure a diverse population can be recruited during the 24-month recruitment period. 120 women will be recruited. Sixty participants will be randomly assigned to the intervention group and receive care using the POSTCare Process and 60 will be randomly assigned to the control group. It is anticipated that our study sample will reflect the ethnic and racial diversity of our clinical settings.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nimrah Saleem, MPH
  • Phone Number: 713-798-2272
  • Email: nsaleem@bcm.edu

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Not yet recruiting
        • UT Southwestern Parkland Health and Hospital System
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Dan L Duncan Comprehensive Cancer Center at the O'Quinn Medical Tower at Baylor St. Luke's Medical Center
        • Contact:
      • Houston, Texas, United States, 77054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage 2-4 ovarian cancer
  • Treated with some combination of surgery, chemotherapy, biologics, maintenance therapy
  • Within 6 months of completion of initial treatment (continued maintenance therapy okay)
  • Able to provide consent in English or Spanish

Exclusion Criteria:

  • Admission to hospice at the completion of treatment for ovary cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Group received care Using POSTCare process
Behavioral: POSTCare Survivorship transition process
Survivorship coaching intervention
No Intervention: Usual Care
Group received usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life by FACT-O
Time Frame: 12 Weeks
Quality of life measured by Functional Assessment of Cancer Therapy - Ovarian instrument composite scorecomprised of physical, emotional, functional, social, and disease specific subscales. Scoring range 0 - 152; a higher score indicates better quality of life.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life by FACT-O
Time Frame: 24 weeks
Quality of life measured by Functional Assessment of Cancer Therapy - Ovarian instrument composite scorecomprised of physical, emotional, functional, social, and disease specific subscales. Scoring range 0 - 152; a higher score indicates better quality of life.
24 weeks
Recurrence Fear
Time Frame: 12 and 24 weeks
Fear of Cancer Recurrence measured by Fear of Cancer Recurrence Inventory Short Form. Range 0-36; higher score indicates higher fear of cancer recurrence.
12 and 24 weeks
Depressive Symptom Burden
Time Frame: 12 and 24 weeks
Depression measured by the Patient Health Questionnaire - 9 . Range 0-27; higher score indicates greater depressive symptom burden.
12 and 24 weeks
Symptom Burden
Time Frame: 12 and 24 weeks
Symptom Burden measured by The M.D. Anderson Symptom Inventory. Range is 1-130; higher score indicates greater symptom burden
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

The University of Texas Health Science Center, Houston
University of Texas Southwestern Medical Center
Cancer Prevention Research Institute of Texas
University of Texas at Austin

Investigators

  • Principal Investigator: Elizabeth Kvale, MD,MPH, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-52939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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