Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy
|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.|
|ClinicalTrials.gov Identifier: NCT02786524|
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Neoplasms Ovarian Neoplasms Gynecologic Neoplasms Fallopian Tube Neoplasms Vulvar Neoplasms Vaginal Neoplasms Peritoneal Neoplasms||Behavioral: Specialized Symptom Management and Supportive Care||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786524
|Contact: Sarah M Blockfirstname.lastname@example.org|
|Contact: Julie A Tumbarelloemail@example.com|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Sarah M Block 734-998-0531 firstname.lastname@example.org|
|Contact: Julie A Tumbarello 734-936-8339 email@example.com|
|Principal Investigator:||Katherine Harris, MD||University of Michigan|
|Principal Investigator:||Carolyn M Johnston, MD||University of Michigan|