Platinum-resistant Ovarian Cancer, Recurrent Ovarian Cancer, Palliative Care
Conditions
Brief summary
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
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.
Interventions
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.
OTHERUsual Care
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (Functional Assessment of Cancer Therapy for Ovarian Cancer and Functional Assessment of Chronic Illness Therapy for Palliative Care) | Every 12 weeks for a maximum of 5 years | 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. |
Countries
United States
Outcome results
None listed