Pilot Study of Early Referral to Interventional Pain Management for Patients With Advanced Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility - Pain Consultation
研究概览
简要总结
The purpose of the study is to evaluate how feasible and beneficial it is to refer patients with cancer pain to a doctor who specializes in pain management, including procedures to relieve pain, and whether this is helpful to patients with pain related to their cancer.
详细描述
This is a single arm pilot study evaluating a new system of referral and pain evaluation for patients with advanced solid tumors and moderate-to-severe pain who are not already on high-dose opioids to an anesthesia-trained interventional pain management specialist .
A variety of interventional treatments for pain have been proven effective for cancer patients. Often without early referral patients do not get evaluated for interventional procedures for their pain unless the pain is very severe, or they are admitted to the hospital. It is expect this intervention will work by providing effective pain treatments to patients sooner than they might normally be referred and will be evaluated by how many patients are candidates for interventional treatments for their pain, whether patients choose to receive these treatments, and whether patients find the pain specialist referral acceptable and helpful
The research study procedures include screening for eligibility, study interventions including evaluations and follow up visits, as well as surveys at the beginning, middle, and end of the study. Participants will be followed on the study for 4 months.
It is expected that about 30 people will take part in this research study.
Medtronic and is providing funding for this research study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a metastatic, or locally advanced unresectable malignancy
- •Anticipated prognosis of more than 6 months according to the primary oncologist
- •Age greater than 21 years
- •Persistent pain with an average pain rating of 4 or greater on an 11-point numeric rating scale (NRS) from 0-10 where 10 is considered the most severe.
- •Pain has persisted for at least 2 weeks
- •Pain is due to cancer or sequelae of cancer treatment
排除标准
- •Primary pain syndrome is sensory peripheral neuropathy
- •Patient is taking more than 200 morphine milligram equivalents (MMEs) per day on average, at the time of recruitment.
- •Currently cared for by interventional pain management specialist
- •Receipt of prior pain intervention (e.g. celiac neurolysis)
- •Bleeding diathesis, uncontrollable infection, or other contra-indications to pain interventions
- •History of opioid misuse disorder
- •Inability to speak English
- •Cognitive impairment or any other disorder that would impede study participation and survey completion
- •If patients are unable to complete the baseline survey, they will no longer be considered eligible for the study; this will serve as an indication of barriers to participation that would make them unable to comply with study procedures.
研究组 & 干预措施
Intervention Arm
Participants will receive early referral to an anesthesia-trained interventional pain management specialist evaluated for pain management strategies.
Participants will complete surveys every 2 months and will have the option of tracking their pain at home using a secure smartphone application.
Participants will be followed on the study for 4 months.
干预措施: Early Referral (Other)
Intervention Arm
Participants will receive early referral to an anesthesia-trained interventional pain management specialist evaluated for pain management strategies.
Participants will complete surveys every 2 months and will have the option of tracking their pain at home using a secure smartphone application.
Participants will be followed on the study for 4 months.
干预措施: Pain Management Strategies (Other)
结局指标
主要结局
Feasibility - Pain Consultation
时间窗: 4 Weeks
Feasibility will be measured by the percentage of patients that have an interventional pain consultation within 4 weeks, with a threshold for determining feasibility of at least 80% of participants.
Feasibility - Interventional Pain Procedure Rate
时间窗: 4 Months
Feasibility will be measured by the percentage of patients who ultimately receive at least one interventional pain procedure, with a threshold for determining feasibility of at least 50% of participants.
Acceptability - Satisfaction Ratings
时间窗: 4 Months
Acceptability will be measured by the percentage of patients satisfied with their interventional pain management care, with a threshold of at least 80% of patients rating the quality of care received at the interventional pain management clinic at a 7 or above on a 0-10 scale (adapted from HCAHPS; 0 being the worst clinic possible, 10 being the best clinic possible). For participants with missing data at 4-months, we imputed their responses at 2-months.
次要结局
未报告次要终点
研究者
Andrea Enzinger, MD
Principal Investigator
Dana-Farber Cancer Institute