Early Interventional Treatment for Cancer Pain

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Pain management strategies	Early Referral	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.
Pain management strategies	Pain Management Strategies	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.

Primary Outcome Measures

Name	Time	Method
Feasibility - Pain Consultation	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	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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (2): Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States