Mindfulness for Pain Management in Patients With Cancer

NCT03351010 | Completed DMC

• 1 other identifier: 12/2561
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Using pharmacologic agents are often effective to treat patients with cancer pain, but there are associated with serious side-effects and risks of dependence and addiction. The Thai Buddhism-based Mindfulness (TBbM) intervention created by a widely respected Buddhist monk focuses on testing a meditation technique to manage pain. If effective, millions of patients who suffer with cancer pain will benefit from use of a safe, culturally appropriate, non-pharmacologic approach to pain management.

Conditions

Cancer, Metastatic; Pain, Chronic

Keywords

Mindfulness, Cancer, Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain Change Over Time

  Worst pain scores are measured by Brief Pain Inventory. The Brief Pain Inventory-Short Form asks about pain in general, pain location, pain intensity (worst, least, average, and present), and is scored on a numerical rating scale of 0 (no pain) to 10 (pain as bad as one can imagine.

  Baseline, 4 weeks and 8 weeks

Secondary Outcomes (5)

• Pain

  Baseline and 8 weeks

• Anxiety and depression

  Baseline and 8 weeks

• Mindfulness

  Baseline and 8 weeks

• Locus of control

  Baseline and 8 weeks

• Quality of life

  Baseline and 8 weeks

Study Arms (2)

Mindfulness

EXPERIMENTAL

Receiving education program and mindfulness training

Behavioral: Mindfulness training program; Device: Cancer pain educational program

Control

ACTIVE COMPARATOR

Receiving education program

Device: Cancer pain educational program

Interventions

Mindfulness training program BEHAVIORAL

The mindfulness training program is a self-awareness mindfulness training program by performing the 15-position hand movement series

Mindfulness

Cancer pain educational program DEVICE

A cancer pain education program by using Videos and personalized face-to-face techniques

Control; Mindfulness

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible patients will:
• have any cancer type or stage,
• be 18-60 years of age,
• have a worst pain score \> 4 in the past 7 days,
• be able to read and write the Thai language,
• have a Karnofsky Performance status \> 70%, and
• be willing to travel to the temple.

You may not qualify if:

• Patients will be diagnosed psychiatric illness
• Patients will have the comorbidities (e.g., arthritis, bone metastasis, deformity, certain neurological conditions such as Brachial plexus nerve compression)

Sponsors & Collaborators

• University of Michigan: lead
• Ministry of Health, Thailand: collaborator

Study Sites (1)

Sawanpracharak Hospital

Maung, Nakhonsawan, 60000, Thailand

Location

Related Publications (1)

• Fish JA, Ettridge K, Sharplin GR, Hancock B, Knott VE. Mindfulness-based cancer stress management: impact of a mindfulness-based programme on psychological distress and quality of life. Eur J Cancer Care (Engl). 2014 May;23(3):413-21. doi: 10.1111/ecc.12136. Epub 2013 Oct 10.

  PMID: 24118428 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis; Chronic Pain; Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Eligible patients will 1) have any cancer type or stage, 2) be 18-60 years of age, 3) have a worst pain score \> 4 in the past 7 days, 4) be able to read and write the Thai language, 5) have a Karnofsky Performance status \> 70%, and be willing to travel to the temple. Exclusion criteria will be any diagnosed psychiatric illness that would prevent the patient from giving informed consent or from participating fully in the study. Patients with comorbidities (e.g., arthritis, bone metastasis, deformity, certain neurologic conditions such as biracial plexus nerve compression) that would impair the ability to perform the hand and arm movements also are ineligible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Instructor

Model Details: Using a randomized controlled trial design, the investigators will test theTBbM intervention to improve pain in Thai outpatients (N=160) with cancer who are receiving cancer care at Sawanpracharak Hospital, Thailand. The control group (n = 80) will receive usual care and participate in a one-hour video educational program about cancer pain. The intervention group (n = 80) will receive usual care, participate in a one-hour video educational program about cancer pain, and receive an 8-week TBbM intervention.

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 22, 2017
• Study Start: May 23, 2018
• Primary Completion: February 6, 2019
• Study Completion: March 31, 2019
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 8 weeks
• Access Criteria: Eligible patients will 1) have any cancer type or stage, 2) be 18-60 years of age, 3) have a worst pain score \> 4 in the past 7 days, 4) be able to read and write the Thai language, 5) have a Karnofsky Performance status \> 70%, and be willing to travel to the temple.

Locations

TH (1)