Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies
NCT ID: NCT02578888
Last Updated: 2019-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2015-04-30
2019-04-30
Brief Summary
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Detailed Description
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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 .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Palliative Therapy
EORTCQLQ-30 and FAMCARE questionnaire every 6 weeks for 3 visits.
Palliative Therapy
Palliative Therapy
Palliative Therapy + idiographic
Ancillary studies
Palliative Therapy+ idiographic
EORTC QLQ-30, and FAMCARE questionnaire every 6 weeks for 3 visits plus patients undergo idiographic assessment.
Palliative Therapy
Palliative Therapy
Palliative Therapy + idiographic
Ancillary studies
Interventions
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Palliative Therapy
Palliative Therapy
Palliative Therapy + idiographic
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \< 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Albert Einstein College of Medicine
OTHER
Responsible Party
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Nicole Nevadunsky
Principal Investigator
Principal Investigators
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Nicole Nevadunsky
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Albert Einstein College of Medicine
The Bronx, New York, United States
Countries
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Other Identifiers
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NCI-2015-00729
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-4421
Identifier Type: OTHER
Identifier Source: secondary_id
2014-4421
Identifier Type: -
Identifier Source: org_study_id
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