Mindfulness for Pain Management in Patients With Cancer

Thai Buddhism-based Mindfulness for Pain Management in Thai Outpatients With Cancer: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic; Cancer, Metastatic
• Intervention / Treatment: Behavioral: Mindfulness training program; Device: Cancer pain educational program

Detailed Description

Cancer is leading cause of death in Thailand. One hundred and twenty-eight men and 83 women per 100,000 had a common consequence both of malignancy and its treatment. Pain is experienced by 62% of Thai patients with cancer. Cancer pain is a major health problem because it causes both physical and psychological suffering for millions of individuals. Although pharmacological/analgesic treatment is effective, adverse side effects are common. Internationally, mindfulness is being used as an effective non-pharmacological treatment for psychological problems including distress, anxiety, stress, depression, and to improve quality of life in patients with cancer. However, the effect of mindfulness on pain as the primary outcome has not been sufficiently investigated. A few randomized controlled trials provide evidence that mindfulness interventions influence pain intensity in patients with cancer pain, but culturally targeted interventions have not been tested. Therefore, the purpose of this research is to test the effect of the Thai Buddhism-based Mindfulness (TBbM) program for pain management in Thai outpatients. 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. Investigators will accomplish the overall objective by pursuing the following three specific aims: 1) to compare the effect of the TBbM intervention to that of usual care on worst pain severity (primary outcome) as measured by the Brief Pain Inventory Thai Version (BPI-T); 2) to compare the effect of the TBbM intervention to that of usual care on secondary outcomes (i.e., pain interference, average pain, anxiety and depression, mindfulness, locus of control, and QoL) as measured by the BPI-T, the Hospital Anxiety and Depression Scale Thai Version (HADS-T), the Mindfulness Assessment Scale Thai Version (MAS-T), the Beliefs in Pain Control Questionnaire Thai Version (BPCQ-T) and the Functional Assessment of Cancer Therapy-General-Thai Version (FACT-G-T); and 3) to explore the mediating effects of TBbM-induced changes in cognitive (locus of control) and psychological factors (anxiety and depression) on worst pain severity. The investigators posit that the TBbM intervention will be more effective than usual care in reducing pain (primary outcome) and improving pain interference, anxiety, depression, mindfulness, locus of control, and QoL (secondary outcomes). T-tests, analysis of covariance (ANOVA), and path analysis approaches will be used to evaluate TBbM outcomes.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Nakhonsawan
    • Maung, Nakhonsawan, Thailand, 60000
      • Sawanpracharak Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; Receiving education program and mindfulness training	Behavioral: Mindfulness training program; The mindfulness training program is a self-awareness mindfulness training program by performing the 15-position hand movement series; Device: Cancer pain educational program; A cancer pain education program by using Videos and personalized face-to-face techniques
Active Comparator: Control; Receiving education program	Device: Cancer pain educational program; A cancer pain education program by using Videos and personalized face-to-face techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain interference and average pain scores are measured by the Brief Pain Inventory	Baseline and 8 weeks
Anxiety and depression	Anxiety and depression scores are measured by the Hospital Anxiety and Depression Scale	Baseline and 8 weeks
Mindfulness	Mindfulness scores are measured by the Mindfulness Assessment Scale	Baseline and 8 weeks
Locus of control	Personal control scores are measured by the Beliefs in Pain Control Questionnaire	Baseline and 8 weeks
Quality of life	Quality of life scores are measured by the Functional Assessment of Cancer Therapy-General-Thai Version	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Ministry of Health, Thailand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): February 6, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Mindfulness, Cancer, Pain Management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 12/2561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual data of the participants that we will collect are cancer data, treatment data, and a time period of mindfulness practice
• IPD Sharing Time Frame: 8 weeks
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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