Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress in Advanced Cancer Patients
- Conditions
- Distress, EmotionalCancer PainPsychiatric or Mood Diseases or ConditionsCancerTherapy-Associated CancerPsychological Distress
- Interventions
- Behavioral: Mindfulness-Based Cognitive-behavioral Therapy for Distress
- Registration Number
- NCT05768256
- Lead Sponsor
- CHA University
- 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.
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 & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 40
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Advanced cancer patients Mindfulness-Based Cognitive-behavioral Therapy for Distress -
- Primary Outcome Measures
Name Time Method Gray matter thickness change at baseline, 8th week Measure the gray matter thickness using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
White matter microstructure change at baseline, 8th week Measure the white matter microstructure using diffusion tensor imaging (DTI) of three-dimensional brain Magnetic Resonance Imaging data.
Gray matter volume change at baseline, 8th week Measure the gray matter volume using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
Distress level change 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.
Brain functional connectivity change at baseline, 8th week Measure the functional connectivity using functional magnetic resonance imaging (fMRI) of three-dimensional brain Magnetic Resonance Imaging data.
DNA methylation levels change at baseline, 8th week Measure the DNA methylation levels using blood collection.
- Secondary Outcome Measures
Name Time Method Demoralization level change 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.
Physical-related quality of life level change 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.
Psychological-related quality of life level change 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.
Self-compassion level change 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.
Thought-action fusion level change 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.
Social-related quality of life level change 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.
Depression level change 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.
Resilience level change 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.
Anxiety level change 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.
Health-related quality of life level change 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.
Mindfulness level change 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.
Environmental-related quality of life level change 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.
Trial Locations
- Locations (1)
CHA Bundang Medical Center
🇰🇷Seongnam-si, Kyeonggi-do, Korea, Republic of