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Mindfulness for Pain Management in Patients With Cancer

Primary Purpose

Cancer, Metastatic, Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Mindfulness training program
Cancer pain educational program
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer, Metastatic focused on measuring Mindfulness, Cancer, Pain Management

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sawanpracharak Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness

Control

Arm Description

Receiving education program and mindfulness training

Receiving education program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2017
Last Updated
March 5, 2021
Sponsor
University of Michigan
Collaborators
Ministry of Health, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT03351010
Brief Title
Mindfulness for Pain Management in Patients With Cancer
Official Title
Thai Buddhism-based Mindfulness for Pain Management in Thai Outpatients With Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Ministry of Health, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Metastatic, Pain, Chronic
Keywords
Mindfulness, Cancer, Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Receiving education program and mindfulness training
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Receiving education program
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training program
Intervention Description
The mindfulness training program is a self-awareness mindfulness training program by performing the 15-position hand movement series
Intervention Type
Device
Intervention Name(s)
Cancer pain educational program
Intervention Description
A cancer pain education program by using Videos and personalized face-to-face techniques
Primary Outcome Measure Information:
Title
Pain Change Over Time
Description
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.
Time Frame
Baseline, 4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
Pain
Description
Pain interference and average pain scores are measured by the Brief Pain Inventory
Time Frame
Baseline and 8 weeks
Title
Anxiety and depression
Description
Anxiety and depression scores are measured by the Hospital Anxiety and Depression Scale
Time Frame
Baseline and 8 weeks
Title
Mindfulness
Description
Mindfulness scores are measured by the Mindfulness Assessment Scale
Time Frame
Baseline and 8 weeks
Title
Locus of control
Description
Personal control scores are measured by the Beliefs in Pain Control Questionnaire
Time Frame
Baseline and 8 weeks
Title
Quality of life
Description
Quality of life scores are measured by the Functional Assessment of Cancer Therapy-General-Thai Version
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Sawanpracharak Hospital
City
Maung
State/Province
Nakhonsawan
ZIP/Postal Code
60000
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.umich.edu
Citations:
PubMed Identifier
24118428
Citation
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.
Results Reference
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Mindfulness for Pain Management in Patients With Cancer

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