Mindfulness for Pain Management in Patients With Cancer

Not Applicable

Completed

• Conditions: Pain, Chronic; Cancer, Metastatic
• Interventions: Device: Cancer pain educational program; Behavioral: Mindfulness training program

• Registration Number: NCT03351010
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Study Start: 2018-05-23
• Primary Completion: 2019-02-06
• Study Completion: 2019-03-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Cancer pain educational program	Receiving education program
Mindfulness	Mindfulness training program	Receiving education program and mindfulness training
Mindfulness	Cancer pain educational program	Receiving education program and mindfulness training

Primary Outcome Measures

Name	Time	Method
Pain Change Over Time	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 Outcome Measures

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

Trial Locations

Locations (1)

Sawanpracharak Hospital; 🇹🇭 Maung, Nakhonsawan, Thailand