A Randomized Study to Evaluate the Effect of Outpatient Symptom Management on Symptom Burden in Advanced Stage or Recurrent Gynecologic Oncology Patients Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Change in Patient-Reported Symptom Burden as Determined by the National Comprehensive Cancer Network Distress Screening Tool
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Specialized Symptom Management and Supportive Care (Behavioral)
结局指标
主要结局
Change in Patient-Reported Symptom Burden as Determined by the National Comprehensive Cancer Network Distress Screening Tool
时间窗: 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.
Change in Patient-Reported Symptom Burden as Determined by the Edmonton Symptom Assessment System
时间窗: 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.
次要结局
- Change in Patient-Reported Distress(3 months after study start, 6 months after study start, and 9 months after study start)
- Baseline Symptom Burden and Palliative Care Needs(Baseline)
- Change in Symptom Burden(6 months after study start and 9 months after study start)
- Overall Survival Rate(Upon study completion, an average of 1 year)
- Change in Patient Adherence to Symptom Management Program(6 months after study start and 9 months after study start)
- Barriers to Symptom Management and Supportive Care(9 months after study start)
研究者
Katherine Harris
Gynecologic Oncology Fellow
University of Michigan