Quality of Life Clinical Trial
— POSTCARE-OOfficial title:
POSTCARE-O: Survivorship Care for Women Living With Ovarian Cancer
NCT number | NCT05752448 |
Other study ID # | H-52939 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2023 |
Est. completion date | April 15, 2027 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 15, 2027 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Parkland Health and Hospital System | Dallas | Texas |
United States | Dan L Duncan Comprehensive Cancer Center at the O'Quinn Medical Tower at Baylor St. Luke's Medical Center | Houston | Texas |
United States | Harris Health Smith Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Cancer Prevention Research Institute of Texas, The University of Texas Health Science Center, Houston, University of Texas at Austin, University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life by FACT-O | 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 | Quality of Life by FACT-O | 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 | |
Secondary | Recurrence Fear | 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 | |
Secondary | Depressive Symptom Burden | Depression measured by the Patient Health Questionnaire - 9 . Range 0-27; higher score indicates greater depressive symptom burden. | 12 and 24 weeks | |
Secondary | Symptom Burden | Symptom Burden measured by The M.D. Anderson Symptom Inventory. Range is 1-130; higher score indicates greater symptom burden | 12 and 24 weeks |
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