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
3 other identifiers
interventional
95
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedSeptember 17, 2019
September 1, 2019
1.1 years
October 13, 2015
September 13, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
We administered a patient satisfaction scale
up to 3 years
Study Arms (2)
Palliative Therapy
ACTIVE COMPARATOREORTCQLQ-30 and FAMCARE questionnaire every 6 weeks for 3 visits.
Palliative Therapy+ idiographic
EXPERIMENTALEORTC QLQ-30, and FAMCARE questionnaire every 6 weeks for 3 visits plus patients undergo idiographic assessment.
Interventions
Palliative Therapy
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Nevadunsky
Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 19, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
April 1, 2019
Last Updated
September 17, 2019
Record last verified: 2019-09