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Completed

NCT Number: NCT03351010

Mindfulness for Pain Management in Patients With Cancer

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sawanpracharak Hospital

Maung, Nakhonsawan, 60000, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness training program

Behavioral

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

Cancer pain educational program

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain

    Time frame: Baseline and 8 weeks

    Pain interference and average pain scores are measured by the Brief Pain Inventory

  2. Anxiety and depression

    Time frame: Baseline and 8 weeks

    Anxiety and depression scores are measured by the Hospital Anxiety and Depression Scale

  3. Mindfulness

    Time frame: Baseline and 8 weeks

    Mindfulness scores are measured by the Mindfulness Assessment Scale

  4. Locus of control

    Time frame: Baseline and 8 weeks

    Personal control scores are measured by the Beliefs in Pain Control Questionnaire

  5. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Ministry of Health, Thailand

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2017
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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