Early Interventional Treatment for Cancer Pain

NCT ID: NCT05366413

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2024-10-26

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

Conditions

Cancer Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early Referral

Intervention Type: OTHER

Directing a patient for a pain specialist consult earlier than standardly occurs.

Pain Management Strategies

Intervention Type: OTHER

Specialized plan with procedures to ease pain

Interventions

Early Referral

Directing a patient for a pain specialist consult earlier than standardly occurs.

Intervention Type: OTHER

Pain Management Strategies

Specialized plan with procedures to ease pain

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Andrea Enzinger, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Enzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-758

Identifier Type: -

Identifier Source: org_study_id