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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02090582
First received: March 4, 2014
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention
Platinum-resistant Ovarian Cancer
Recurrent Ovarian Cancer
Palliative Care
Other: Structured Palliative Care
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Every 12 weeks for a maximum of 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02090582

Contacts
Contact: Paula S Lee, MD 9196686793 paula.s.lee@duke.edu
Contact: Jessie A Ehrisman, BA 9196849065 jessie.ehrisman@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Paula S Lee, MD    919-668-6793    paula.s.lee@duke.edu   
Contact: Jessie A Ehrisman, BA    9196849065    jessie.ehrisman@duke.edu   
Principal Investigator: Paula S Lee, MD         
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02090582     History of Changes
Other Study ID Numbers: Pro00052239
Study First Received: March 4, 2014
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014