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

This study is currently recruiting participants.
Verified October 2015 by Nicole Nevadunsky, Albert Einstein College of Medicine of Yeshiva University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02578888
First Posted: October 19, 2015
Last Update Posted: October 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nicole Nevadunsky, Albert Einstein College of Medicine of Yeshiva University
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nicole Nevadunsky, Albert Einstein College of Medicine of Yeshiva University:

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. [ Time Frame: Baseline ]
    To validate a model of proactive palliative medicine referral; We hypothesize 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. [ Time Frame: Up to 3 years ]
    To quantify the impact of PCARE versus PCARE + idiographic assessment on quality of care and patient satisfaction. We theorize that early consultation will result in decreased 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. [ Time Frame: Up to 3 years ]
    Utilize 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. [ Time Frame: up to 3 years ]
    To determine the impact of a proactive model of palliative care consultation at the time of diagnosis on family/caregivers. We propose that early palliative medicine consultation will result in increased family/caregiver satisfaction.


Estimated Enrollment: 180
Study Start Date: April 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Quality of Life Assessment

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 .

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578888


Contacts
Contact: Eileen Burke, RN 718-405-8082 eburke@montefiore.org

Locations
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Nicole S. Nevadunsky    718-405-8082    nnevadun@montefiore.org   
Principal Investigator: Nicole S. Nevadunsky         
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nicole Nevadunsky Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Nicole Nevadunsky, Principal Investigator, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT02578888     History of Changes
Other Study ID Numbers: 2014-4421
NCI-2015-00729 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-4421 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2015
First Posted: October 19, 2015
Last Update Posted: October 19, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Peritoneal Neoplasms
Vulvar Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms
Abdominal Neoplasms
Digestive System Neoplasms
Carcinoma
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Digestive System Diseases
Peritoneal Diseases
Vulvar Diseases