Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

March 19, 2019 updated by: Katherine Harris, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: 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

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
Time Frame: Baseline and 3 months after study start
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
Time Frame: Baseline and 3 months after study start
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
Time Frame: Baseline
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
Time Frame: 3 months after study start, 6 months after study start, and 9 months after study start
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
Time Frame: 6 months after study start and 9 months after study start
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
Time Frame: 6 months after study start and 9 months after study start
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
Time Frame: 9 months after study start
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
Time Frame: Upon study completion, an average of 1 year
Overall survival will be compared between the two study arms.
Upon study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Katherine Harris, MD, University of Michigan
  • Principal Investigator: Carolyn M Johnston, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00089412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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