Survivorship Care for Women Living With Ovarian Cancer: (POSTCARE-O)
Sponsored by Baylor College of Medicine
About this study
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 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 treatmen…
Where this study is enrolling (3)
- I'm interested
Dan L Duncan Comprehensive Cancer Center at the O'Quinn Medical Tower at Baylor St. Luke's Medical Center
Houston, Texas
- I'm interested
Harris Health Smith Clinic
Houston, Texas
- I'm interested
UT Southwestern Parkland Health and Hospital System
Dallas, Texas
Who can participate
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
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Trial data sourced from ClinicalTrials.gov.