Mindfulness for Pain Management in Patients With Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2019-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cancer, Metastatic Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Mindfulness

Receiving education program and mindfulness training

Group Type EXPERIMENTAL

Mindfulness training program

Intervention Type BEHAVIORAL

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

Cancer pain educational program

Intervention Type DEVICE

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

Control

Receiving education program

Group Type ACTIVE_COMPARATOR

Cancer pain educational program

Intervention Type DEVICE

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

Interventions

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Mindfulness training program

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

Intervention Type BEHAVIORAL

Cancer pain educational program

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No