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NCT Number: NCT02786524

Effect of Outpatient Symptom Management on 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specialized Symptom Management and Supportive Care

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. Overall Survival Rate

    Time frame: Upon study completion, an average of 1 year

    Overall survival will be compared between the two study arms.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2016
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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