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Trial record 4 of 8 for:    palliative | Recruiting Studies | Cervical Cancer

Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy

This study is currently recruiting participants.
Verified June 2017 by Katherine Harris, University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT02786524
First Posted: June 1, 2016
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Katherine Harris, University of Michigan
  Purpose
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.

Condition Intervention
Uterine Cervical Neoplasms Ovarian Neoplasms Gynecologic Neoplasms Fallopian Tube Neoplasms Vulvar Neoplasms Vaginal Neoplasms Peritoneal Neoplasms Behavioral: Specialized Symptom Management and Supportive Care

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

Resource links provided by NLM:


Further study details as provided by Katherine Harris, University of Michigan:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • Overall Survival Rate [ Time Frame: Upon study completion, an average of 1 year ]
    Overall survival will be compared between the two study arms.


Estimated Enrollment: 180
Study Start Date: February 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786524


Contacts
Contact: Sarah M Block 734-998-0531 smblock@med.umich.edu
Contact: Julie A Tumbarello 734-936-8339 jtumbare@med.umich.edu

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sarah M Block    734-998-0531    smblock@med.umich.edu   
Contact: Julie A Tumbarello    734-936-8339    jtumbare@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Katherine Harris, MD University of Michigan
Principal Investigator: Carolyn M Johnston, MD University of Michigan
  More Information

Responsible Party: Katherine Harris, Gynecologic Oncology Fellow, University of Michigan
ClinicalTrials.gov Identifier: NCT02786524     History of Changes
Other Study ID Numbers: HUM00089412
First Submitted: May 10, 2016
First Posted: June 1, 2016
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Katherine Harris, University of Michigan:
Palliative Care
Triage
Symptom Evaluation
Chemotherapy
Patient Distress

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Vulvar Neoplasms
Vaginal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Vulvar Diseases
Vaginal Diseases