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

Not Applicable

Completed

• Conditions: Palliative Care; Recurrent Ovarian Cancer; Platinum-resistant Ovarian Cancer
• Interventions: Other: Structured Palliative Care; Other: Usual Care

• Registration Number: NCT02090582
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Study Start: 2014-04
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

• Platinum-resistant ovarian cancer or recurrent ovarian cancer
• Ability to read and respond to questions in English

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured Palliative Care	Structured Palliative Care	-
Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States