Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

NCT ID: NCT02786524

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-15
• Study Completion Date: 2017-10-31

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.

Conditions

Uterine Cervical Neoplasms; Ovarian Neoplasms; Gynecologic Neoplasms; Fallopian Tube Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Peritoneal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Symptom Management and Supportive Care

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.

Group Type: EXPERIMENTAL

Specialized Symptom Management and Supportive Care

Intervention Type: BEHAVIORAL

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

Interventions

Specialized Symptom Management and Supportive Care

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Katherine Harris

Gynecologic Oncology Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Harris, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Carolyn M Johnston, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00089412

Identifier Type: -

Identifier Source: org_study_id