Clinical trial NCT05752448: Survivorship Care for Women Living With Ovarian Cancer: (POSTCARE-O)
Official title: POSTCARE-O: Survivorship Care for Women Living With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Neoplasm
Depressive Symptoms
Quality of Life
Keywords: Ovarian Cancer
Survivorship
Cancer Survivor
Depression
Palliative Care
Quality of Life
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
name: The University of Texas Health Science Center, Houston
name: University of Texas Southwestern Medical Center
name: University of Texas at Austin
First posted: 2023-03-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial double blinded
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Quality of Life by FACT-O
timeFrame: 12 Weeks
Secondary outcomes:
measure: Quality of Life by FACT-O
timeFrame: 24 weeks
measure: Recurrence Fear
timeFrame: 12 and 24 weeks
measure: Depressive Symptom Burden
timeFrame: 12 and 24 weeks
measure: Symptom Burden
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Parkland Health and Hospital System
state: Texas
city: Houston
country: United States
facility: Dan L Duncan Comprehensive Cancer Center at the O'Quinn Medical Tower at Baylor St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Harris Health Smith Clinic
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Elizabeth Kvale, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: