- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05768256
Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress in Advanced Cancer Patients (MBCT)
A Study of Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress (MBCT-D) in Advanced Cancer Patients Using Neurophysiological Data
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The number of subjects participating in this study is up to 40 advanced cancer patients. The research subject is responsible for the medical expenses incurred in the usual standard medical procedures, and the researcher is responsible for the examination expenses (brain magnetic resonance imaging, blood sampling) performed by participating in other studies.
This study runs until Feb 01, 2024. After enrolling in the study, patients with advanced cancer participate in mindfulness-based behavioral therapy once a week for eight weeks. All research subjects participating in this study will have an interview to collect basic information, fill out a questionnaire for index evaluation, blood collection, and brain magnetic resonance imaging. Participants participating in this study will receive specific evaluations as follows.
- Interview to gather basic information: demographic information, (if applicable) psychiatric symptoms and treatment-related information are collected.
- Filling out questionnaires for psychological evaluation and behavioral data collection: 4 times [Baseline, 2 weeks later, 4 weeks later, 8 weeks later (Post-treatment)], Psychiatry Fill out a questionnaire to comprehensively evaluate your symptoms and psychological state.
- Blood collection: 6ml of blood is collected twice before and after treatment.
- Brain Magnetic Resonance Imaging: Make an appointment and visit the examination room in the hospital to perform a total of 2 times before and after treatment.
Clinical symptom and progress data are collected if patients have previously been treated at this hospital, and medical information that occurs after study registration is collected every one month during the study participation period.
Distress Indicators
- 2022 NCCN Guidelines for Distress Management's Korean version of Distress Thermometer (DT) and Problem List (PL)
- Perceived Stress Scale-4 (PSS-4) Indicators of depression and anxiety characteristics
- Brief Edinburgh Depression Scale (BEDS)
- Beck Depression Inventory-ll (BDI-ll)
- Beck Anxiety Inventory (BAI)
- Hospital Anxiety and Depression Scale (HADS) Mindfulness Characteristics and Symptom Related Indicators
- Toronto Mindfulness Scale (TMS)
- Self-Compassion Scale-Short Form (SCS-SF)
- Demoralization Scale-II (DS-II-Kr)
- Thought-Action Fusion Scale (TAFS) Quality of life and resilience indicators
- Functional Assessment Cancer Therapy-General (FACT-G)
- WHO Quality of Life-BREF (WHOQOL-BREF)
- The Brief Resilience Scale (BRS) Epigenetic data
- DNA methylation analysis flow DNA preparation → uracil change of non-methylated cytosine using bisulfate → amplification using PCR → methylation detection by methylation specific PCR
- Selection of candidate genes - Experience in prior research on OXTR and FKBP5gene → Application to same gene methylation studies Brain imaging data
- Acquisition of magnetic resonance imaging (MRI) - structural imaging (T1), functional imaging (fMRI), diffusion tensor imaging (DTI)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hwang
- Phone Number: +82 010-5587-7874
- Email: hyg7874@chauniv.ac.kr
Study Locations
-
-
Kyeonggi-do
-
Seongnam-si, Kyeonggi-do, Korea, Republic of, 13496
- CHA Bundang Medical Center
-
Contact:
- Hwang
- Phone Number: 82+ 010-5587-7874
- Email: hyg7874@chauniv.ac.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A person diagnosed with gastric cancer, colon cancer, lung cancer, liver cancer, breast cancer, cervical cancer, prostate cancer, or other cancers from a doctor, and a advanced cancer patient with a cancer stage of 2 to 4
- Those who wish to participate in the Mindfulness-Based Cognitive Behavioral Treatment for distress (MBCT-D) program
Exclusion Criteria:
- A person with a history of neurological disease, head trauma accompanied by loss of consciousness, brain metastasis of cancer, and mental retardation (IQ<70).
- Pregnant and lactating
- If the symptoms are severe or the reality testing ability and judgment are considered to be significantly deteriorated through a mental health examination by a psychiatrist
- A person who is determined to be at risk of serious suicide or violent behavior in the mental state test
- A foreigner (a non-Korean person)
- A person who is illiterate in Korean
- A left-handed person
- A person who has previously experienced mindfulness-based cognitive behavioral therapy
- A person who the researcher determines that it is inappropriate to participate in clinical research for other reasons
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Advanced cancer patients
|
Mindfulness-based cognitive-behavioral therapy, MBCT, is a modified form of cognitive-behavioral therapy that incorporates mindfulness practices that include present moment awareness, meditation, and breathing exercises.
Advanced cancer patients will participate in the study until the end of the study (Feb 2024).
After registering for the study, the study subjects receive mindfulness-based cognitive behavioral therapy once a week for eight weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distress level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the distress levels using the Distress Thermometer.
The Distress Thermometer ranged from 0 to 10. Higher scores indicate more severe distress.
|
at baseline, 2nd week, 4th week, 8th week
|
Gray matter volume change
Time Frame: at baseline, 8th week
|
Measure the gray matter volume using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
|
at baseline, 8th week
|
Gray matter thickness change
Time Frame: at baseline, 8th week
|
Measure the gray matter thickness using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
|
at baseline, 8th week
|
White matter microstructure change
Time Frame: at baseline, 8th week
|
Measure the white matter microstructure using diffusion tensor imaging (DTI) of three-dimensional brain Magnetic Resonance Imaging data.
|
at baseline, 8th week
|
Brain functional connectivity change
Time Frame: at baseline, 8th week
|
Measure the functional connectivity using functional magnetic resonance imaging (fMRI) of three-dimensional brain Magnetic Resonance Imaging data.
|
at baseline, 8th week
|
DNA methylation levels change
Time Frame: at baseline, 8th week
|
Measure the DNA methylation levels using blood collection.
|
at baseline, 8th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the depressive levels using the Brief Edinburgh Depression Scale.
The Brief Edinburgh Depression Scale ranged from 0 to 18, with higher scores indicating more depression.
|
at baseline, 2nd week, 4th week, 8th week
|
Depression level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the depressive levels using the Beck Depression Inventory-ll.
The Beck Depression Inventory-ll ranged from 0 to 63, with higher scores indicating more depression.
|
at baseline, 2nd week, 4th week, 8th week
|
Depression level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the depressive levels using the Hospital Anxiety and Depression Scale.
The Hospital Anxiety and Depression Scale ranged from 0 to 21, with higher scores indicating more depression.
|
at baseline, 2nd week, 4th week, 8th week
|
Anxiety level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the depressive levels using the Hospital Anxiety and Depression Scale.
The Hospital Anxiety and Depression Scale ranged from 0 to 21, with higher scores indicating more anxiety.
|
at baseline, 2nd week, 4th week, 8th week
|
Anxiety level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the anxiety levels using the Beck Anxiety Inventory.
Scale ranged from 0 to 63, with higher scores indicating more anxiety.
|
at baseline, 2nd week, 4th week, 8th week
|
Mindfulness level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the mindfulness levels using the Toronto Mindfulness Scale.
The Toronto Mindfulness Scale ranged from 13 to 65, with higher scores indicating more mindfulness.
|
at baseline, 2nd week, 4th week, 8th week
|
Self-compassion level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the mindfulness levels using the Self-Compassion Scale-Short Form.
The Self-Compassion Scale-Short Form ranged from 12 to 60, with higher scores indicating more self-compassion.
|
at baseline, 2nd week, 4th week, 8th week
|
Demoralization level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the mindfulness levels using the Demoralization Scale-II.
The Demoralization Scale-II ranged from 0 to 32, with higher scores indicating more demoralization.
|
at baseline, 2nd week, 4th week, 8th week
|
Thought-action fusion level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the mindfulness levels using the Thought-Action Fusion Scale.
The Thought-Action Fusion Scale ranged from 0 to 76, with higher scores indicating a greater thought-action fusion.
|
at baseline, 2nd week, 4th week, 8th week
|
Health-related quality of life level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the health-related quality of life levels using the Functional Assessment Cancer Therapy-General.
The Functional Assessment Cancer Therapy-General ranged from 0 to 108, with higher scores indicating more health-related quality of life.
|
at baseline, 2nd week, 4th week, 8th week
|
Physical-related quality of life level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the physical-related quality of life levels using the Physical domain of WHO Quality of Life-BREF.
The Physical domain of WHO Quality of Life-BREF ranged from 0 to 20, with higher scores indicating more physical-related quality of life.
|
at baseline, 2nd week, 4th week, 8th week
|
Psychological-related quality of life level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the psychological-related quality of life levels using the Psychological domain of WHO Quality of Life-BREF.
The Psychological domain of WHO Quality of life-BREF ranged from 0 to 20, with higher scores indicating more psychological-related quality of life.
|
at baseline, 2nd week, 4th week, 8th week
|
Social-related quality of life level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the social-related quality of life levels using the Social domain of WHO Quality of Life-BREF.
The Social domain of WHO Quality of life-BREF ranged from 0 to 20, with higher scores indicating more social-related quality of life.
|
at baseline, 2nd week, 4th week, 8th week
|
Environmental-related quality of life level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the environmental-related quality of life levels using the Environmental domain of WHO Quality of Life-BREF.
The Environmental domain of WHO Quality of Life-BREF ranged from 0 to 20, with higher scores indicating more environmental-related quality of life.
|
at baseline, 2nd week, 4th week, 8th week
|
Resilience level change
Time Frame: at baseline, 2nd week, 4th week, 8th week
|
Measure the resilience levels using the The Brief Resilience Scale.
The Brief Resilience Scale ranged from 6 to 30, with higher scores indicating more resilience.
|
at baseline, 2nd week, 4th week, 8th week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Wurtzen H, Dalton SO, Elsass P, Sumbundu AD, Steding-Jensen M, Karlsen RV, Andersen KK, Flyger HL, Pedersen AE, Johansen C. Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Eur J Cancer. 2013 Apr;49(6):1365-73. doi: 10.1016/j.ejca.2012.10.030. Epub 2012 Dec 19.
- Kim B, Lee SH, Kim YW, Choi TK, Yook K, Suh SY, Cho SJ, Yook KH. Effectiveness of a mindfulness-based cognitive therapy program as an adjunct to pharmacotherapy in patients with panic disorder. J Anxiety Disord. 2010 Aug;24(6):590-5. doi: 10.1016/j.janxdis.2010.03.019. Epub 2010 Apr 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHAMC 2022-12-050
- NRF-2021R1I1A1A01048880 (Other Grant/Funding Number: Ministry of Education)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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