Clinical trial NCT05768256: Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress in Advanced Cancer Patients
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
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Pain
Cancer
Distress, Emotional
Therapy-Associated Cancer
Psychiatric or Mood Diseases or Conditions
Psychological Distress
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Distress level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Gray matter volume change
timeFrame: at baseline, 8th week
measure: Gray matter thickness change
timeFrame: at baseline, 8th week
measure: White matter microstructure change
timeFrame: at baseline, 8th week
measure: Brain functional connectivity change
timeFrame: at baseline, 8th week
measure: DNA methylation levels change
timeFrame: at baseline, 8th week
Secondary outcomes:
measure: Depression level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Depression level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Depression level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Anxiety level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Anxiety level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Mindfulness level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Self-compassion level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Demoralization level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Thought-action fusion level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Health-related quality of life level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Physical-related quality of life level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Psychological-related quality of life level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Social-related quality of life level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Environmental-related quality of life level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
measure: Resilience level change
timeFrame: at baseline, 2nd week, 4th week, 8th week
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Kyeonggi-do
Study officials:
References:
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.
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.