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.
Brief Title
Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies
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 .
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 .
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cervical Carcinoma
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Recurrent Cervical Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Uterine Corpus Carcinoma
Recurrent Vulvar Carcinoma
Uterine Corpus Cancer
Vulvar Carcinoma
Peritoneal Neoplasms
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT02578888
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2014-4421
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Early Palliative Medicine Intervention Using Idiographic Assessment for Women With High Risk Gynecologic Malignancies
Primary Outcomes
Outcome Description
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.
Outcome Measure
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.
Outcome Time Frame
Baseline
Outcome Description
We measured ACE and decreased direct hospital cost of care in the last 6 months of life between patients randomized and refusing randomization.
Outcome Measure
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.
Outcome Time Frame
Up to 3 years
Outcome Description
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.
Outcome Measure
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.
Outcome Time Frame
Up to 3 years
Outcome Description
We administered a patient satisfaction scale
Outcome Measure
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.
Outcome Time Frame
up to 3 years
Secondary Ids
Secondary Id
NCI-2015-00729
Secondary Id
2014-4421
Secondary Id
P30CA013330
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nicole Nevadunsky
Investigator Email
nnevadun@montefiore.org
Investigator Phone
718-405-8082