Survivorship Care for Women Living With Ovarian Cancer: (POSTCARE-O)
NCT ID: NCT05752448
Last Updated: 2024-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-10-01
2027-04-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention group
Group received care Using POSTCare process
POSTCare Survivorship transition process
Survivorship coaching intervention
Usual Care
Group received usual care
No interventions assigned to this group
Interventions
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POSTCare Survivorship transition process
Survivorship coaching intervention
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Cancer Prevention Research Institute of Texas
OTHER
The University of Texas Health Science Center, Houston
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Texas at Austin
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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Elizabeth A Kvale
Associate Professor of Medicine
Principal Investigators
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Elizabeth Kvale, MD,MPH
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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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, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Kvale E, Phillips F, Ghosh S, Lea J, Hoppenot C, Costales A, Sunde J, Badr H, Nwogu-Onyemkpa E, Saleem N, Ward R, Balasubramanian B. Survivorship Care for Women Living With Ovarian Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 9;13:e48069. doi: 10.2196/48069.
Other Identifiers
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H-52939
Identifier Type: -
Identifier Source: org_study_id
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