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

Palliative Care Clinical Trial

Official title:

Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090582
• Other study ID #: Pro00052239
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Palliative Care
• Platinum-resistant Ovarian Cancer
• Recurrent Ovarian Cancer

Intervention

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
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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every 12 weeks for a maximum of 5 years