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Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress in Advanced Cancer Patients (MBCT)

Primary Purpose

Cancer Pain, Cancer, Distress, Emotional

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive-behavioral Therapy for Distress
Sponsored by
CHA University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHA Bundang Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Advanced cancer patients

Arm Description

Outcomes

Primary Outcome Measures

Distress level change
Measure the distress levels using the Distress Thermometer. The Distress Thermometer ranged from 0 to 10. Higher scores indicate more severe distress.
Gray matter volume change
Measure the gray matter volume using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
Gray matter thickness change
Measure the gray matter thickness using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
White matter microstructure change
Measure the white matter microstructure using diffusion tensor imaging (DTI) of three-dimensional brain Magnetic Resonance Imaging data.
Brain functional connectivity change
Measure the functional connectivity using functional magnetic resonance imaging (fMRI) of three-dimensional brain Magnetic Resonance Imaging data.
DNA methylation levels change
Measure the DNA methylation levels using blood collection.

Secondary Outcome Measures

Depression level change
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.
Depression level change
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.
Depression level change
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.
Anxiety level change
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.
Anxiety level change
Measure the anxiety levels using the Beck Anxiety Inventory. Scale ranged from 0 to 63, with higher scores indicating more anxiety.
Mindfulness level change
Measure the mindfulness levels using the Toronto Mindfulness Scale. The Toronto Mindfulness Scale ranged from 13 to 65, with higher scores indicating more mindfulness.
Self-compassion level change
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.
Demoralization level change
Measure the mindfulness levels using the Demoralization Scale-II. The Demoralization Scale-II ranged from 0 to 32, with higher scores indicating more demoralization.
Thought-action fusion level change
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.
Health-related quality of life level change
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.
Physical-related quality of life level change
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.
Psychological-related quality of life level change
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.
Social-related quality of life level change
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.
Environmental-related quality of life level change
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.
Resilience level change
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.

Full Information

First Posted
February 7, 2023
Last Updated
April 3, 2023
Sponsor
CHA University
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1. Study Identification

Unique Protocol Identification Number
NCT05768256
Brief Title
Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress in Advanced Cancer Patients
Acronym
MBCT
Official Title
A Study of Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress (MBCT-D) in Advanced Cancer Patients Using Neurophysiological Data
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
'Distress' refers to emotional distress, including psychological distress, in cancer patients. This study aims to explore whether mindfulness-based cognitive-behavioral therapy for cancer patients is effective in relieving distress and to discover neurophysiological factors that contribute to relieving distress. Mindfulness meditation, which is the core of mindfulness-based cognitive behavioral therapy, can develop cognitive flexibility through 'awareness of what is happening now'. In this study, a mindfulness-based cognitive behavioral therapy program is implemented for patients with advanced cancer, and clinical characteristics and conditions including distress level are observed through questionnaires and interviews. In addition, genetic data and brain imaging data are collected through blood sampling and brain magnetic resonance imaging. The ultimate goal of this study is to prove the therapeutic efficacy of a mindfulness-based cognitive behavioral therapy program for distress of patients with advanced cancer through an in-depth and multifaceted integrated approach, and to understand the related neurophysiological mechanisms.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain, Cancer, Distress, Emotional, Therapy-Associated Cancer, Psychiatric or Mood Diseases or Conditions, Psychological Distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced cancer patients
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive-behavioral Therapy for Distress
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distress level change
Description
Measure the distress levels using the Distress Thermometer. The Distress Thermometer ranged from 0 to 10. Higher scores indicate more severe distress.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Gray matter volume change
Description
Measure the gray matter volume using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
Time Frame
at baseline, 8th week
Title
Gray matter thickness change
Description
Measure the gray matter thickness using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
Time Frame
at baseline, 8th week
Title
White matter microstructure change
Description
Measure the white matter microstructure using diffusion tensor imaging (DTI) of three-dimensional brain Magnetic Resonance Imaging data.
Time Frame
at baseline, 8th week
Title
Brain functional connectivity change
Description
Measure the functional connectivity using functional magnetic resonance imaging (fMRI) of three-dimensional brain Magnetic Resonance Imaging data.
Time Frame
at baseline, 8th week
Title
DNA methylation levels change
Description
Measure the DNA methylation levels using blood collection.
Time Frame
at baseline, 8th week
Secondary Outcome Measure Information:
Title
Depression level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Depression level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Depression level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Anxiety level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Anxiety level change
Description
Measure the anxiety levels using the Beck Anxiety Inventory. Scale ranged from 0 to 63, with higher scores indicating more anxiety.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Mindfulness level change
Description
Measure the mindfulness levels using the Toronto Mindfulness Scale. The Toronto Mindfulness Scale ranged from 13 to 65, with higher scores indicating more mindfulness.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Self-compassion level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Demoralization level change
Description
Measure the mindfulness levels using the Demoralization Scale-II. The Demoralization Scale-II ranged from 0 to 32, with higher scores indicating more demoralization.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Thought-action fusion level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Health-related quality of life level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Physical-related quality of life level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Psychological-related quality of life level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Social-related quality of life level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Environmental-related quality of life level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week
Title
Resilience level change
Description
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.
Time Frame
at baseline, 2nd week, 4th week, 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHA Bundang Medical Center
City
Seongnam-si
State/Province
Kyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23265707
Citation
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.
Results Reference
background
PubMed Identifier
20427148
Citation
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.
Results Reference
background

Learn more about this trial

Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress in Advanced Cancer Patients

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