Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy



Status:Completed
Conditions:Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Women's Studies, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:February 15, 2016
End Date:October 31, 2017

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A Randomized Study to Evaluate the Effect of Outpatient Symptom Management on Symptom Burden in Advanced Stage or Recurrent Gynecologic Oncology Patients Receiving Chemotherapy

To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic
improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy
patients compared with symptom management performed by the primary gynecologic oncologist.

Patients with gynecologic malignancies often have a high prevalence of symptoms throughout
their disease course including fatigue, pain, anxiety and depression. Palliative care is
defined by the World Health Organization (WHO) as "an approach that improves the quality of
life of 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."

The University of Michigan Symptom Management and Supportive Care Program works together with
patient's oncology team to manage cancer related and treatment related symptoms. They offer a
wide range of services including: pain and symptom management, medication management,
nutritional counseling, expedited access to psychiatric oncology, anesthesia pain service and
physical medicine and rehabilitation. Studies have demonstrated an improvement in quality of
life, symptom burden and patient/care giver satisfaction when palliative care is part of
routine oncologic care. Currently, in gynecologic oncology, palliative care is incorporated
on a case by case basis, instead of in a standardized approach. We hope this study will
provide a standardized tool to identify gynecologic oncology patients receiving chemotherapy
who would benefit from a referral to a symptom management clinic.

This study will provide a screening mechanism to identify advanced stage or recurrent
gynecologic oncology chemotherapy patients with palliative care needs and determine which
symptom management option provides the best improvement in symptom burden, that performed by
a specialty clinic staffed by providers formally trained in palliative care or that provided
by the patient's gynecologic oncologist. This study has the potential to change practice by
providing a triage tool that will identify patients that will most benefit from specialty
palliative care services and could result in improved quality of life for our patients.

Inclusion Criteria:

- Female

- 18 years of age or older

- Diagnosis of Stage III, IV, or recurrent gynecologic malignancy (Uterine, Ovarian,
Cervical, Vulvar, Vaginal, Fallopian Tube, Primary Peritoneal)

- Receiving active intravenous, intraperitoneal, or oral chemotherapy

- Patient at University of Michigan Gynecologic Oncology Clinic

Exclusion Criteria:

- Male

- Less than 18 years of age

- Patients without a diagnosis of a gynecologic malignancy

- Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time
of enrollment

- Patients receiving radiation therapy with chemo-sensitization.
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Phone: 734-998-0531
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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mi
from
Ann Arbor, MI
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