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

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02578888

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Palliative Therapy Other: Palliative Therapy + idiographic	N/A

Detailed Description

PRIMARY OBJECTIVES:

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

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

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: Palliative Care Symptom Management 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: Palliative Care Symptom Management Other: Palliative Therapy + idiographic Ancillary studies Other Names: Quality of Life Assessment

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:

Palliative Care

Symptom Management

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:

Palliative Care

Symptom Management

Other: Palliative Therapy + idiographic

Ancillary studies

Other Names:

Quality of Life Assessment

Outcome Measures

Primary Outcome Measures

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. [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.
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. [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.
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. [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.
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. [up to 3 years]
We administered a patient satisfaction scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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