H.O.P.E: Helping Ovarian Cancer Patients Cope
Conditions
Platinum-resistant Ovarian Cancer - Recurrent Ovarian Cancer - Palliative Care
Conditions: official terms
Ovarian Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Structured Palliative Care Type: Other
Name: Usual Care Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Paula S Lee, MD - 919-668-6793 - paula.s.lee@duke.edu
Start Date
April 2014
Sponsors
Duke University
Source
Duke University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page