NCT05768256

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

February 7, 2023

Last Update Submit

April 3, 2023

Conditions

Cancer PainCancerDistress, EmotionalTherapy-Associated CancerPsychiatric or Mood Diseases or ConditionsPsychological Distress

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • DNA methylation levels change

    Measure the DNA methylation levels using blood collection.

    at baseline, 8th week

Secondary Outcomes (15)

  • Depression level change

    at baseline, 2nd week, 4th week, 8th week

  • Depression level change

    at baseline, 2nd week, 4th week, 8th week

  • Depression level change

    at baseline, 2nd week, 4th week, 8th week

  • Anxiety level change

    at baseline, 2nd week, 4th week, 8th week

  • Anxiety level change

    at baseline, 2nd week, 4th week, 8th week

  • +10 more secondary outcomes

Study Arms (1)

Advanced cancer patients

EXPERIMENTAL
Behavioral: Mindfulness-Based Cognitive-behavioral Therapy for Distress

Interventions

Mindfulness-Based Cognitive-behavioral Therapy for DistressBEHAVIORAL

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.

Advanced cancer patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Kyeonggi-do, 13496, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 23265707BACKGROUND

  • 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.

    PMID: 20427148BACKGROUND

MeSH Terms

Conditions

Cancer PainNeoplasmsNeoplasms, Second Primary

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2023

First Posted

March 14, 2023

Study Start

March 28, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

April 5, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)