Early Interventional Treatment for Cancer Pain

Pilot Study of Early Referral to Interventional Pain Management for Patients With Advanced Malignancies

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.

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

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 is feasibility and acceptability. Feasibility and acceptability will be measured by the proportion of patients that undergo an interventional pain consultation within 4 weeks: >80%

Primary outcome is feasibility and acceptability. Feasibility and acceptability will be measured by the proportion of patients referred and evaluated by an anesthesia pain specialist, at least 50% will agree and ultimately receive at least one interventional pain procedure

Primary outcome is feasibility and acceptability. Feasibility and acceptability will be measured by the proportion of patients satisfied with their interventional pain management care, at least 80% of patients will be satisfied with their care defined as rating it a 4 or 5 on a 5-point Likert scale.

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 90 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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.