- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03351010
Mindfulness for Pain Management in Patients With Cancer
March 5, 2021 updated by: Srisuda Ngamkham, University of Michigan
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nakhonsawan
-
Maung, Nakhonsawan, Thailand, 60000
- Sawanpracharak hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness
Receiving education program and mindfulness training
|
The mindfulness training program is a self-awareness mindfulness training program by performing the 15-position hand movement series
A cancer pain education program by using Videos and personalized face-to-face techniques
|
Active Comparator: Control
Receiving education 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
Time Frame: Baseline, 4 weeks and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
Pain interference and average pain scores are measured by the Brief Pain Inventory
|
Baseline and 8 weeks
|
Anxiety and depression
Time Frame: Baseline and 8 weeks
|
Anxiety and depression scores are measured by the Hospital Anxiety and Depression Scale
|
Baseline and 8 weeks
|
Mindfulness
Time Frame: Baseline and 8 weeks
|
Mindfulness scores are measured by the Mindfulness Assessment Scale
|
Baseline and 8 weeks
|
Locus of control
Time Frame: Baseline and 8 weeks
|
Personal control scores are measured by the Beliefs in Pain Control Questionnaire
|
Baseline and 8 weeks
|
Quality of life
Time Frame: Baseline and 8 weeks
|
Quality of life scores are measured by the Functional Assessment of Cancer Therapy-General-Thai Version
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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