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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02090582
Recruitment Status : Active, not recruiting
First Posted : March 18, 2014
Last Update Posted : July 24, 2017
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Platinum-resistant Ovarian Cancer Recurrent Ovarian Cancer Palliative Care Other: Structured Palliative Care Other: Usual Care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence
Actual Study Start Date : April 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Structured Palliative Care Other: Structured Palliative Care
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.

Usual Care Other: Usual 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.

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Every 12 weeks for a maximum of 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02090582

United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Paula S Lee, MD Duke University

Responsible Party: Duke University Identifier: NCT02090582     History of Changes
Other Study ID Numbers: Pro00052239
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders