Mindfulness for Pain Management in Patients With Cancer
Condition: Cancer, Metastatic; Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): Mindfulness training program; Cancer pain educational program
Intervention type(s): Behavioral; Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Single (Participant)
Primary purpose: Treatment
Keywords: Mindfulness, Cancer, Pain Management