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

Cancer Clinical Trial

— MBCT  

Official title:

A Study of Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress (MBCT-D) in Advanced Cancer Patients Using Neurophysiological Data

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05768256
• Other study ID #: CHAMC 2022-12-050
• Secondary ID: NRF-2021R1I1A1A0
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

1. Interview to gather basic information: demographic information, (if applicable) psychiatric symptoms and treatment-related information are collected.

2. 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.

3. Blood collection: 6ml of blood is collected twice before and after treatment.

4. 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Distress, Emotional
• Neoplasms, Second Primary
• Psychiatric or Mood Diseases or Conditions
• Psychological Distress
• Therapy-Associated Cancer

Intervention

Behavioral:
• Mindfulness-Based Cognitive-behavioral Therapy for Distress
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.

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center	Seongnam-si	Kyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline, 2nd week, 4th week, 8th week
Primary	Gray matter volume change	Measure the gray matter volume using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.	at baseline, 8th week
Primary	Gray matter thickness change	Measure the gray matter thickness using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.	at baseline, 8th week
Primary	White matter microstructure change	Measure the white matter microstructure using diffusion tensor imaging (DTI) of three-dimensional brain Magnetic Resonance Imaging data.	at baseline, 8th week
Primary	Brain functional connectivity change	Measure the functional connectivity using functional magnetic resonance imaging (fMRI) of three-dimensional brain Magnetic Resonance Imaging data.	at baseline, 8th week
Primary	DNA methylation levels change	Measure the DNA methylation levels using blood collection.	at baseline, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	Anxiety level change	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
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week
Secondary	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.	at baseline, 2nd week, 4th week, 8th week