Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

Study Overview
=================
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.

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

Conditions
-----------------
Uterine Cervical Neoplasms, Ovarian Neoplasms, Gynecologic Neoplasms, Fallopian Tube Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Peritoneal Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Specialized Symptom Management and Supportive Care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Patients randomized to this arm receive standard symptom management care by their primary gynecologic oncologist and complete the NCCN distress thermometer and ESAS-r at each visit, every 3-4 weeks. | |
| Experimental: Symptom Management and Supportive Care<br>Patients randomized to this arm are referred to a specialized symptom management and supportive care clinic and seen within two weeks. Patients will be seen in follow-up as recommended by the symptom management providers, and at each visit they will complete the ESAS-r and NCCN distress thermometer and return their responses either in person or by mail to the study team in a pre-addressed postage paid envelope. | Behavioral: Specialized Symptom Management and Supportive Care<br>* Based on Patients who score 5 or higher on the Baseline Patient Palliative Care Survey that will identify patients that will most benefit from specialty palliative care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Reported Symptom Burden as Determined by the Edmonton Symptom Assessment System | To determine if referral to a symptom management clinic improves the symptom burden quantified by the patients' Edmonton Symptom Assessment System (ESAS) scores. | Baseline and 3 months after study start | 
| Change in Patient-Reported Symptom Burden as Determined by the National Comprehensive Cancer Network Distress Screening Tool | To determine if referral to a symptom management clinic improves the symptom burden quantified by the patients' National Comprehensive Cancer Network (NCCN) Distress Screening Tool scores. | Baseline and 3 months after study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Symptom Burden and Palliative Care Needs | To determine the baseline symptom burden and palliative care needs upon enrollment of patients with advanced stage or recurrent gynecologic malignancies receiving chemotherapy. | Baseline | 
| Change in Patient-Reported Distress | Measure changes in patient-reported distress using the NCCN Distress Thermometer | 3 months after study start, 6 months after study start, and 9 months after study start | 
| Change in Symptom Burden | Evaluate changes in patients' symptom burden with the ESAS-r to evaluate the ongoing sustained effect of the intervention. | 6 months after study start and 9 months after study start | 
| Change in Patient Adherence to Symptom Management Program | To analyze patients in the symptom management arms with a 3-item questionnaire to determine what factors are associated with adherence to a symptom management program. | 6 months after study start and 9 months after study start | 
| Barriers to Symptom Management and Supportive Care | Analyze barriers that prevented patients from attending the Symptom Management and Supportive Care Clinic, as identified in a 3-item questionnaire. | 9 months after study start | 
| Overall Survival Rate | Overall survival will be compared between the two study arms. | Upon study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative Care, Triage, Symptom Evaluation, Chemotherapy, Patient Distress