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Trial Title:
Survivorship Care for Women Living With Ovarian Cancer: (POSTCARE-O)
NCT ID:
NCT05752448
Condition:
Ovarian Neoplasm
Depressive Symptoms
Quality of Life
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Depression
Conditions: Keywords:
Ovarian Cancer
Survivorship
Cancer Survivor
Depression
Palliative Care
Quality of Life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial double blinded
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
Will mask all study personnel except care provider who will not be engaged with data
interpretation
Intervention:
Intervention type:
Behavioral
Intervention name:
POSTCare Survivorship transition process
Description:
Survivorship coaching intervention
Arm group label:
Intervention group
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Only females at birth have ovaries
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UT Southwestern Parkland Health and Hospital System
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Carolina Salmeron
Phone:
713-500-0147
Email:
Carolina.Salmeron@uth.tmc.edu
Facility:
Name:
Dan L Duncan Comprehensive Cancer Center at the O'Quinn Medical Tower at Baylor St. Luke's Medical Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lilian Moraes de Vasconcelos
Phone:
713-798-4785
Email:
Lilian.MoraesdeVasconcelos@bcm.edu
Facility:
Name:
Harris Health Smith Clinic
Address:
City:
Houston
Zip:
77054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lilian Moraes de Vasconcelos
Phone:
713-798-4785
Email:
Lilian.MoraesdeVasconcelos@bcm.edu
Start date:
October 1, 2023
Completion date:
April 15, 2027
Lead sponsor:
Agency:
Baylor College of Medicine
Agency class:
Other
Collaborator:
Agency:
Cancer Prevention Research Institute of Texas
Agency class:
Other
Collaborator:
Agency:
The University of Texas Health Science Center, Houston
Agency class:
Other
Collaborator:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Collaborator:
Agency:
University of Texas at Austin
Agency class:
Other
Source:
Baylor College of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05752448
