- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02578888
Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies
Early Palliative Medicine Intervention Using Idiographic Assessment for Women With High Risk Gynecologic Malignancies
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein College Of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Palliative Therapy
Other Names:
Ancillary studies
Other Names:
|
EXPERIMENTAL: Palliative Therapy+ idiographic
EORTC QLQ-30, and FAMCARE questionnaire every 6 weeks for 3 visits plus patients undergo idiographic assessment.
|
Palliative Therapy
Other Names:
Ancillary studies
Other Names:
|
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
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Abdominal Neoplasms
- Vulvar Diseases
- Carcinoma
- Recurrence
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Vulvar Neoplasms
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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