Ovarian Cancer Clinical Trial

Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

Summary

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.

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Full Description

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.

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Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

107

Study ID:

NCT02786524

Recruitment Status:

Completed

Sponsor:

University of Michigan

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There is 1 Location for this study

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University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States

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Study is for people with:

Ovarian Cancer

Estimated Enrollment:

107

Study ID:

NCT02786524

Recruitment Status:

Completed

Sponsor:


University of Michigan

How clear is this clinincal trial information?

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