Cancer PainMBCTNCT05768256
Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress in Advanced Cancer Patients
A study testing Mindfulness-Based Cognitive-behavioral Therapy for Distress in people with Cancer Pain and Cancer, run by CHA University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer Pain, Cancer, Distress, Emotional
- What is being tested?
- Mindfulness-Based Cognitive-behavioral Therapy for Distress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center
Seongnam-si, Kyeonggi-do, 13496
About this study
Official title: A Study of Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress (MBCT-D) in Advanced Cancer Patients Using Neurophysiological Data
'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.
Read the 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)
- Conditions
- Cancer Pain, Cancer, Distress, Emotional, Therapy-Associated Cancer, Psychiatric or Mood Diseases or Conditions, Psychological Distress
- Being tested
- Mindfulness-Based Cognitive-behavioral Therapy for Distress
- Medical subject headings
- Cancer Pain, Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive-behavioral Therapy for DistressBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced cancer patients | Experimental | Not described Receives: Behavioral: Mindfulness-Based Cognitive-behavioral Therapy for Distress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline, 8th week
DNA methylation levels change
Measure the DNA methylation levels using blood collection.
Measured: at baseline, 8th week
Secondary outcomes (15)
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
Anxiety level change
Measure the anxiety levels using the Beck Anxiety Inventory. Scale ranged from 0 to 63, with higher scores indicating more anxiety.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
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.
Measured: at baseline, 2nd week, 4th week, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start28 Mar 2023
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Il Park, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768256
- Sponsor's protocol ID
- CHAMC 2022-12-050
- Other IDs
- NRF-2021R1I1A1A01048880
- Acronym
- MBCT
- Status last verified
- Apr 2023
- First submitted
- 7 Feb 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23265707Kim 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.
PubMed 20427148
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Treatment Efficacy of Mindfulness-based Cognitive Therapy for Distress (MBCT-D) in Advanced Cancer Patients Using Neurophysiological Data
- ClinicalTrials.gov ID
- NCT05768256
- Acronym / sponsor ID
- MBCT / CHAMC 2022-12-050
- Conditions
- Cancer Pain, Cancer, Distress, Emotional, Therapy-Associated Cancer, Psychiatric or Mood Diseases or Conditions, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced cancer patients | Experimental | Behavioral: Mindfulness-Based Cognitive-behavioral Therapy for Distress |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive-behavioral Therapy for DistressMindfulness-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. | Behavioural | Advanced cancer patients |
Primary outcome
Distress level change
Time frame: 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.
Gray matter volume change
Time frame: at baseline, 8th week
Measure the gray matter volume using fast spoiled gradient-echo (FSPGR) of three-dimensional brain Magnetic Resonance Imaging data.
Gray matter thickness change
Time frame: 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
Time frame: at baseline, 8th week
Measure the white matter microstructure using diffusion tensor imaging (DTI) of three-dimensional brain Magnetic Resonance Imaging data.
Brain functional connectivity change
Time frame: 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
Time frame: at baseline, 8th week
Measure the DNA methylation levels using blood collection.
15 secondary outcomes
Depression level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Depression level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Depression level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Anxiety level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Anxiety level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Mindfulness level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Self-compassion level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Demoralization level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Thought-action fusion level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Health-related quality of life level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Physical-related quality of life level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Psychological-related quality of life level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Social-related quality of life level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Environmental-related quality of life level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Resilience level change
Time frame: at baseline, 2nd week, 4th week, 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Background: PubMed 23265707Wurtzen 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.
- Background: PubMed 20427148Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive-behavioral Therapy for Distress in people with Cancer Pain and Cancer, run by CHA University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress level change (time frame: at baseline, 2nd week, 4th week, 8th week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05768256, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.