Early Interventional Treatment for Cancer Pain

Cancer Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05366413
• Other study ID #: 21-758
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 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

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Other:
• Early Referral
Directing a patient for a pain specialist consult earlier than standardly occurs.
• Pain Management Strategies
Specialized plan with procedures to ease pain

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Consultation Participation Rate	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%	4 Weeks up to 4 months
Primary	Pain Care Participation Rate	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	4 Weeks up to 4 months
Primary	Satisfaction Ratings	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.	4 Weeks up to 4 months