Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies

September 13, 2019 updated by: Nicole Nevadunsky, Albert Einstein College of Medicine

Early Palliative Medicine Intervention Using Idiographic Assessment for Women With High Risk Gynecologic Malignancies

This randomized clinical trial studies a palliative care program in improving the quality of life of patients with high-risk gynecologic malignancies that is original or first tumor in the body (primary) or has come back (recurrent). Palliative care is care given to patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a palliative care program may help doctors learn more about patients quality of life, use of healthcare services, and the relief of pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Validate a model of proactive palliative medicine referral. II. Quantify the impact of palliative care aggressive care at the end-of-life (PCARE) versus PCARE + idiographic assessment on quality of care and patient satisfaction.

III. Utilizing CMO data Investigators will create a cost model for patients randomized to PCARE versus patients refusing randomization.

IV. Determine the impact of a proactive model of palliative care consultation at the time of diagnosis on family/caregivers.

OUTLINE: Patients are randomized 1 of 2 arms.

GROUP I (usual PCARE): Patients complete European Organization for Research and Treatment of Cancer quality of life-30 (EORTCQLQ-30) and Family Satisfaction with Advanced Cancer Care (FAMCARE) questionnaire every 6 weeks for 3 visits.

GROUP II: (usual PCARE + idiographic assessment): Patients complete EORTC QLQ-30, and FAMCARE questionnaire as in Group I and undergo idiographic assessment. Beginning within 4 weeks of their visit with the gynecologic oncologist, patients are referred to outpatient palliative medicine consultation.

After completion of study, patients are followed up periodically .

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with of primary or recurrent diagnosis of ovarian, uterine, peritoneal, cervical or vulvar cancer with any of the following:

    • < 30 % projected 5 year survival based on histopathological stage
    • Non-pelvic recurrent malignancy
    • Persistent or progressive disease despite primary treatment with surgery, chemotherapy or
    • Palliative performance scale < 60
  • Enrollment within 6 weeks of tumor board review

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Palliative Therapy
EORTCQLQ-30 and FAMCARE questionnaire every 6 weeks for 3 visits.
Other: Palliative Therapy
Palliative Therapy
Other Names:
  • Symptom Management
  • Palliative Care
Other: Palliative Therapy + idiographic
Ancillary studies
Other Names:
  • Quality of Life Assessment
EXPERIMENTAL: Palliative Therapy+ idiographic
EORTC QLQ-30, and FAMCARE questionnaire every 6 weeks for 3 visits plus patients undergo idiographic assessment.
Other: Palliative Therapy
Palliative Therapy
Other Names:
  • Symptom Management
  • Palliative Care
Other: Palliative Therapy + idiographic
Ancillary studies
Other Names:
  • Quality of Life Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure increased utilization (move from 18% to over 50%) of palliative medicine and increased proportion of patients receiving services more then 30 days before death as compared to historical controls.
Time Frame: Baseline
To validate a model of proactive palliative medicine referral; We recorded that proactive referral will result in a clinically relevant increase of utilization of palliative medicine services (>70% of eligible women will have at least 1 consultation) and facilitate proxy assignment and improve pain/symptom control. There will be increased utilization of palliative care.
Baseline
Measured by differential in aggresive care at end-of-life from direct hospital costs in the last 6 months of life between patients that are randomized and refuse randomization.
Time Frame: Up to 3 years
We measured ACE and decreased direct hospital cost of care in the last 6 months of life between patients randomized and refusing randomization.
Up to 3 years
Evaluate costs related to procedures, laboratories, radiographic studies, intensive care admission, and blood transfusion to create a model of potential cost savings as generalized to patients with non-gynecologic cancers within the CMO.
Time Frame: Up to 3 years
We utilized CMO data to create a cost model for patients randomized to PCARE versus patients refusing randomization. Costs related to potentially "preventable spends" will be obtained from the CMO database for eligible patients.
Up to 3 years
FAMCARE Survey will be administered, a 20 item scale measuring the degree to which family members are satisfied with the healthcare providers' behaviors. Comparison of family member scores between 2 arms, as well as at face value will be evaluated.
Time Frame: up to 3 years
We administered a patient satisfaction scale
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (ESTIMATE)

October 19, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-4421 (OTHER: Albert Einstein College of Medicine)
  • P30CA013330 (U.S. NIH Grant/Contract)
  • NCI-2015-00729 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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