Early Interventional Treatment for Cancer Pain

NCT05366413 | Completed Results

• 1 other identifier: 21-758
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer Pain

Keywords

Cancer Pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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; Other: Pain Management Strategies

Interventions

Early Referral OTHER

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

Intervention Arm

Pain Management Strategies OTHER

Specialized plan with procedures to ease pain

Intervention Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Medtronic: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andrea Enzinger, MD
• Organization: Dana-Farber Cancer Institute

andrea_enzinger@dfci.harvard.edu

617-582-7335

Study Officials

• Andrea Enzinger, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: June 2, 2022
• Primary Completion: February 26, 2024
• Study Completion: October 26, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)