Survivorship Care for Women Living With Ovarian Cancer: (POSTCARE-O)

Study Overview
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Brief Summary
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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
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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.

Official Title
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POSTCARE-O: Survivorship Care for Women Living With Ovarian Cancer

Conditions
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Ovarian Neoplasm, Depressive Symptoms, Quality of Life

Intervention / Treatment
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* Behavioral: POSTCare Survivorship transition process


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial double blinded
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Group received care Using POSTCare process | Behavioral: POSTCare Survivorship transition process<br>* Survivorship coaching intervention<br>|
| No Intervention: Usual Care<br>Group received usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Ovarian Cancer, Survivorship, Cancer Survivor, Palliative Care, Quality of Life