Cancer, MetastaticNCT03351010
Mindfulness for Pain Management in Patients With Cancer
A study testing Mindfulness training program and Cancer pain educational program in people with Cancer, Metastatic and Pain, Chronic, run by University of Michigan at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cancer, Metastatic, Pain, Chronic
- What is being tested?
- Mindfulness training program and Cancer pain educational program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteThailand
- Study dates
- 23 May 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Metastatic, Pain, Chronic
- Being tested
- Mindfulness training program, Cancer pain educational program
- Keywords
- Mindfulness, Cancer, Pain Management
- Medical subject headings
- Neoplasm Metastasis, Chronic Pain, Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness training programBehavioural
The mindfulness training program is a self-awareness mindfulness training program by performing the 15-position hand movement series
Cancer pain educational programDevice
A cancer pain education program by using Videos and personalized face-to-face techniques
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Receiving education program and mindfulness training Receives: Behavioral: Mindfulness training program; Device: Cancer pain educational program |
| Control | Active comparator | Receiving education program Receives: Device: Cancer pain educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Change Over Time
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.
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (5)
Pain
Pain interference and average pain scores are measured by the Brief Pain Inventory
Measured: Baseline and 8 weeks
Anxiety and depression
Anxiety and depression scores are measured by the Hospital Anxiety and Depression Scale
Measured: Baseline and 8 weeks
Mindfulness
Mindfulness scores are measured by the Mindfulness Assessment Scale
Measured: Baseline and 8 weeks
Locus of control
Personal control scores are measured by the Beliefs in Pain Control Questionnaire
Measured: Baseline and 8 weeks
Quality of life
Quality of life scores are measured by the Functional Assessment of Cancer Therapy-General-Thai Version
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start23 May 2018
- Primary completion6 Feb 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, MetastaticStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Responsible party
- Principal investigator, Srisuda Ngamkham, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351010
- Sponsor's protocol ID
- 12/2561
- Status last verified
- Mar 2021
- First submitted
- 16 Nov 2017
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual data of the participants that we will collect are cancer data, treatment data, and a time period of mindfulness practice
Publications
Fish JA, Ettridge K, Sharplin GR, Hancock B, Knott VE. Mindfulness-based cancer stress management: impact of a mindfulness-based programme on psychological distress and quality of life. Eur J Cancer Care (Engl). 2014 May;23(3):413-21. doi: 10.1111/ecc.12136. Epub 2013 Oct 10.
PubMed 24118428
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thai Buddhism-based Mindfulness for Pain Management in Thai Outpatients With Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT03351010
- Acronym / sponsor ID
- 12/2561
- Conditions
- Cancer, Metastatic, Pain, Chronic
- Keywords
- Mindfulness, Cancer, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- 23 May 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness training program, Device: Cancer pain educational programReceiving education program and mindfulness training |
| Control | Active comparator | Device: Cancer pain educational programReceiving education program |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness training programThe mindfulness training program is a self-awareness mindfulness training program by performing the 15-position hand movement series | Behavioural | Mindfulness |
| Cancer pain educational programA cancer pain education program by using Videos and personalized face-to-face techniques | Device | Control, Mindfulness |
Primary outcome
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.
5 secondary outcomes
Pain
Time frame: Baseline and 8 weeks
Anxiety and depression
Time frame: Baseline and 8 weeks
Mindfulness
Time frame: Baseline and 8 weeks
Locus of control
Time frame: Baseline and 8 weeks
Quality of life
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Results publication: PubMed 24118428Fish JA, Ettridge K, Sharplin GR, Hancock B, Knott VE. Mindfulness-based cancer stress management: impact of a mindfulness-based programme on psychological distress and quality of life. Eur J Cancer Care (Engl). 2014 May;23(3):413-21. doi: 10.1111/ecc.12136. Epub 2013 Oct 10.
- Individual participant dataSharing planned: Yes. The individual data of the participants that we will collect are cancer data, treatment data, and a time period of mindfulness practice
Related trials for Cancer, Metastatic
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training program and Cancer pain educational program in people with Cancer, Metastatic and Pain, Chronic, run by University of Michigan at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Change Over Time (time frame: Baseline, 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03351010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.