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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured Palliative Care
Usual Care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Platinum-resistant Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Structured Palliative Care

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2014
Last Updated
May 11, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02090582
Brief Title
H.O.P.E: Helping Ovarian Cancer Patients Cope
Official Title
Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum-resistant Ovarian Cancer, Recurrent Ovarian Cancer, Palliative Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured Palliative Care
Arm Type
Other
Arm Title
Usual Care
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Structured Palliative Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life (Functional Assessment of Cancer Therapy for Ovarian Cancer and Functional Assessment of Chronic Illness Therapy for Palliative Care)
Description
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.
Time Frame
Every 12 weeks for a maximum of 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula S Lee, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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

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