Non-Small Cell Lung CancerNCT06224504
Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione
A study testing routine health education, psychological nursing and MBSR therapy in people with Non-Small Cell Lung Cancer, run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control group received conventional psychological… Read more about this study
- Who is it for?
- Ages 44 to 65 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- routine health education, psychological nursing and MBSR therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 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 44 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with non-small cell lung cancer
- patients aged between 20 and 74 years, without gender limitation
- a score of 4-14 on the Short Symptom Rating Scale (BSRS-5)
- a clinical prognosis of at least 6 months
- clear consciousness, good functional ability, and unrestricted language communication
- written informed consent provided by the patient
Who cannot join
- patients with severe physical illnesses or symptoms that impede learning and are considered life-threatening
- patients with a BSRS-5 assessment score > 15 and suicidal ideation > 2
- patients unable to accurately describe their symptoms
- patients with limited cooperation ability
- patients who have previously undergone MBSR or other positive-thinking-focused psychotherapy methods
Trial locations and contacts
1 site in 1 country.
China1 site
Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients with Non-Small Cell Lung Cancer
Taiyuan, Shanxi, 030032
About this study
Official title: Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients With Non-Small Cell Lung Cancer
This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.
Read the detailed description
To assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC). A total of 60 lung cancer patients from a hospital in Shanxi Province were selected using convenience sampling and divided into an intervention group and a control group, with 30 patients in each group. The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. The two group were evaluated by the questionnaire three times. One day before the intervention, the first questionnaire was conducted, and the basic data of the two groups of patients were collected. The second questionnaire evaluation of anxiety, depression, sleep quality, and the Brief Symptom Rating Scale (BSRS-5) was conducted 6 weeks after the end of the intervention, and the third questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate the intervention effect of the two groups. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- routine health education, psychological nursing, MBSR therapy, exercise therapy
- Keywords
- Lung cancer, Mindfulness-Based Stress Reduction, Exercise intervention, Anxiety, Depression
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine health educationBehavioural
guided the diet of patients, and introduced the knowledge of the disease in detail
psychological nursingBehavioural
hen the patient has negative emotions, patiently listen to the patient's expression, and timely provide language comfort and guidance to the negative psychological emotions
MBSR therapyBehavioural
Conducted in small groups once a week for 8 weeks, with each session lasting approximately 1-1.5 hours, encompassed mindfulness-based breathing exercises, dietary interventions, and body scans
exercise therapyBehavioural
Participants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day
| Study group | Role | What they receive |
|---|---|---|
| the intervention group | Experimental | routine health education ， psychological nursing， MBSR therapy ， exercise therapy Receives: Behavioral: routine health education; Behavioral: psychological nursing; Behavioral: MBSR therapy; Behavioral: exercise therapy |
| the control group | Active comparator | routine health education ， psychological nursing Receives: Behavioral: routine health education; Behavioral: psychological nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAS score
Self-Rating Anxiety Scale (SAS)
Measured: one day before the intervention
SAS score
Self-Rating Anxiety Scale (SAS)
Measured: at 6 weeks after the intervention
SAS score
Self-Rating Anxiety Scale (SAS)
Measured: at 8 weeks after the intervention
SDS score
Self-Rating Depression Scale (SDS)
Measured: one day before the intervention
SDS score
Self-Rating Depression Scale (SDS)
Measured: at 6 weeks after the intervention
SDS score
Self-Rating Depression Scale (SDS)
Measured: at 8 weeks after the intervention
BSRS-5 score
the five-item Brief Symptom Rating Scale (BSRS-5)
Measured: one day before the intervention
BSRS-5 score
the five-item Brief Symptom Rating Scale (BSRS-5)
Measured: at 6 weeks after the intervention
BSRS-5 score
the five-item Brief Symptom Rating Scale (BSRS-5)
Measured: at 8 weeks after the intervention
PSQI score
Pittsburgh Sleep Quality Index (PSQI)
Measured: one day before the intervention
PSQI score
Pittsburgh Sleep Quality Index (PSQI)
Measured: at 6 weeks after the intervention
PSQI score
Pittsburgh Sleep Quality Index (PSQI)
Measured: at 8 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanling Li, Shanxi Bethune Hospital
- Investigators
- Wanling Li, Principal investigator, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224504
- Sponsor's protocol ID
- SBH-001
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06224504
- Acronym / sponsor ID
- SBH-001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Lung cancer, Mindfulness-Based Stress Reduction, Exercise intervention, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 25 Jan 2024 (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.
This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.
Detailed description
To assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC). A total of 60 lung cancer patients from a hospital in Shanxi Province were selected using convenience sampling and divided into an intervention group and a control group, with 30 patients in each group. The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. The two group were evaluated by the questionnaire three times. One day before the intervention, the first questionnaire was conducted, and the basic data of the two groups of patients were collected. The second questionnaire evaluation of anxiety, depression, sleep quality, and the Brief Symptom Rating Scale (BSRS-5) was conducted 6 weeks after the end of the intervention, and the third questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate the intervention effect of the two groups. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Behavioral: routine health education, Behavioral: psychological nursing, Behavioral: MBSR therapy, Behavioral: exercise therapyroutine health education ， psychological nursing， MBSR therapy ， exercise therapy |
| the control group | Active comparator | Behavioral: routine health education, Behavioral: psychological nursingroutine health education ， psychological nursing |
Who may qualify
- Ages
- 44 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients diagnosed with non-small cell lung cancer
- patients aged between 20 and 74 years, without gender limitation
- a score of 4-14 on the Short Symptom Rating Scale (BSRS-5)
- a clinical prognosis of at least 6 months
- clear consciousness, good functional ability, and unrestricted language communication
Key exclusion criteria (5 listed)
- patients with severe physical illnesses or symptoms that impede learning and are considered life-threatening
- patients with a BSRS-5 assessment score > 15 and suicidal ideation > 2
- patients unable to accurately describe their symptoms
- patients with limited cooperation ability
- patients who have previously undergone MBSR or other positive-thinking-focused psychotherapy methods
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 |
|---|---|---|
| routine health educationguided the diet of patients, and introduced the knowledge of the disease in detail | Behavioural | the control group, the intervention group |
| psychological nursinghen the patient has negative emotions, patiently listen to the patient's expression, and timely provide language comfort and guidance to the negative psychological emotions | Behavioural | the control group, the intervention group |
| MBSR therapyConducted in small groups once a week for 8 weeks, with each session lasting approximately 1-1.5 hours, encompassed mindfulness-based breathing exercises, dietary interventions, and body scans | Behavioural | the intervention group |
| exercise therapyParticipants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day | Behavioural | the intervention group |
Primary outcome
SAS score
Time frame: one day before the intervention
Self-Rating Anxiety Scale (SAS)
SAS score
Time frame: at 6 weeks after the intervention
Self-Rating Anxiety Scale (SAS)
SAS score
Time frame: at 8 weeks after the intervention
Self-Rating Anxiety Scale (SAS)
SDS score
Time frame: one day before the intervention
Self-Rating Depression Scale (SDS)
SDS score
Time frame: at 6 weeks after the intervention
Self-Rating Depression Scale (SDS)
SDS score
Time frame: at 8 weeks after the intervention
Self-Rating Depression Scale (SDS)
BSRS-5 score
Time frame: one day before the intervention
the five-item Brief Symptom Rating Scale (BSRS-5)
BSRS-5 score
Time frame: at 6 weeks after the intervention
the five-item Brief Symptom Rating Scale (BSRS-5)
BSRS-5 score
Time frame: at 8 weeks after the intervention
the five-item Brief Symptom Rating Scale (BSRS-5)
PSQI score
Time frame: one day before the intervention
Pittsburgh Sleep Quality Index (PSQI)
PSQI score
Time frame: at 6 weeks after the intervention
Pittsburgh Sleep Quality Index (PSQI)
PSQI score
Time frame: at 8 weeks after the intervention
Pittsburgh Sleep Quality Index (PSQI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1/2
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Ovarian Cancer, Non-small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Advanced or Metastatic Non-small Cell Lung Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Active, not recruitingPhase 3
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)
Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation
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.
Wanling Li principal investigator
Shanxi Bethune Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine health education, psychological nursing and MBSR therapy in people with Non-Small Cell Lung Cancer, run by Shanxi Bethune Hospital at 1 site in China.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jan 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SAS score (time frame: one day before the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2024.