H.O.P.E: Helping Ovarian Cancer Patients Cope

Study Overview
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Brief Summary
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The purpose of this study is to test the effect of the gynecologic oncologists with palliative care specialist collaboration (GO-PC) intervention on patient quality of life.

Detailed Description
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Eligible patients include women diagnosed with platinum-resistant ovarian cancer or recurrent ovarian cancer cancer. All patient participants will complete two quality of life (QOL) questionnaires and a cost-diary documenting their health care experience at time of consent and every 12 weeks thereafter. Consenting care givers will also be asked to complete two questionnaires to asses the impact of structured palliative care on them every 12 weeks. Patients will be assigned to two arms randomly: 1) usual care or 2) structured palliative care. The primary endpoint is quality of life. A two-sided Chi-square test will be used to compare the proportion of patients who have improved quality of life after treatment between control arm and intervention arm. The average value of multiple scores after treatment will be used to compare with the baseline score before treatment for each question in the standard questionnaire.

Official Title
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Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence

Conditions
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Recurrent Ovarian Cancer, Palliative Care, Platinum-resistant Ovarian Cancer

Intervention / Treatment
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* Other: Structured Palliative Care
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Platinum-resistant ovarian cancer or recurrent ovarian cancer Ability to read and respond to questions in English Exclusion Criteria: Platinum-sensitive recurrent ovarian cancer without a significant clinical event Existence of co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Structured Palliative Care<br> | Other: Structured Palliative Care<br>* Structured palliative care approach, defined as the gynecologic oncology team performing comprehensive symptom assessment with the Quality Data Collection Tool Palliative Care (QDACT-PC) and providing interventions based on National Comprehensive Cancer Network (NCCN) guidelines. Symptom scores above the acceptable threshold in the QDACT-PC tool that occur after two consecutive visits will automatically trigger palliative care consultation.<br>|
| Other: Usual Care<br> | Other: Usual Care<br>* Usual care described as current practice by the gynecologic oncology team with referral to PC specialist at provider discretion or at the request of the patient or their families.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (Functional Assessment of Cancer Therapy for Ovarian Cancer and Functional Assessment of Chronic Illness Therapy for Palliative Care) | A combined FACT-O and FACIT-PAL (version 4)16 will be administered at baseline and 12 week intervals on all subjects. The FACT Measurement System is a validated group of questions that measure health-related QOL in cancer patients. Both questionnaires have identical questions for physical well-being, functional well-being, emotional well-being, and social well-being. The additional subscales of the FACT-O and FACIT-PAL will be combined to provide a comprehensive quality of life assessment specific to ovarian cancer and palliative care. | Every 12 weeks for a maximum of 5 years |