Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | April 2019 |
| Contact: | Eileen Burke, RN |
| Email: | eburke@montefiore.org |
| Phone: | 718-405-8082 |
Early Palliative Medicine Intervention Using Idiographic Assessment for Women With High Risk Gynecologic Malignancies
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.
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.
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 .
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
We found this trial at
1
site
1300 Morris Park Ave
Bronx, New York 10461
Bronx, New York 10461
(718) 430-2000
Principal Investigator: Nicole S. Nevadunsky
Phone: 718-405-8082
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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