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.

Study Overview

• Status: Completed
• Conditions: Cancer Pain
• Intervention / Treatment: Other: Early Referral; Other: Pain Management Strategies

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Early Referral; Directing a patient for a pain specialist consult earlier than standardly occurs.; Other: Pain Management Strategies; Specialized plan with procedures to ease pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Pain Consultation	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.	4 Weeks
Feasibility - Interventional Pain Procedure Rate	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.	4 Months
Acceptability - Satisfaction Ratings	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.	4 Months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Medtronic
• Investigators: Principal Investigator: Andrea Enzinger, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): October 26, 2024

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Cancer Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: 21-758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No