Clinical trial NCT02786524: Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy
Official title: A Randomized Study to Evaluate the Effect of Outpatient Symptom Management on Symptom Burden in Advanced Stage or Recurrent Gynecologic Oncology Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Ovarian Neoplasms
Gynecologic Neoplasms
Fallopian Tube Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Peritoneal Neoplasms
Keywords: Palliative Care
Triage
Symptom Evaluation
Chemotherapy
Patient Distress
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Change in Patient-Reported Symptom Burden as Determined by the Edmonton Symptom Assessment System
timeFrame: Baseline and 3 months after study start
measure: Change in Patient-Reported Symptom Burden as Determined by the National Comprehensive Cancer Network Distress Screening Tool
timeFrame: Baseline and 3 months after study start
Secondary outcomes:
measure: Baseline Symptom Burden and Palliative Care Needs
timeFrame: Baseline
measure: Change in Patient-Reported Distress
timeFrame: 3 months after study start, 6 months after study start, and 9 months after study start
measure: Change in Symptom Burden
timeFrame: 6 months after study start and 9 months after study start
measure: Change in Patient Adherence to Symptom Management Program
timeFrame: 6 months after study start and 9 months after study start
measure: Barriers to Symptom Management and Supportive Care
timeFrame: 9 months after study start
measure: Overall Survival Rate
timeFrame: Upon study completion, an average of 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Katherine Harris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Carolyn M Johnston, MD
role: PRINCIPAL_INVESTIGATOR
References: