Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients With Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06224504
• Other study ID #: SBH-001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: Shanxi Bethune Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 44 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Behavioral:
• routine health education
guided the diet of patients, and introduced the knowledge of the disease in detail
• psychological nursing
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 therapy
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 therapy
Participants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day

Locations

Country	Name	City	State
China	Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients with Non-Small Cell Lung Cancer	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanxi Bethune Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAS score	Self-Rating Anxiety Scale (SAS)	one day before the intervention
Primary	SAS score	Self-Rating Anxiety Scale (SAS)	at 6 weeks after the intervention
Primary	SAS score	Self-Rating Anxiety Scale (SAS)	at 8 weeks after the intervention
Primary	SDS score	Self-Rating Depression Scale (SDS)	one day before the intervention
Primary	SDS score	Self-Rating Depression Scale (SDS)	at 6 weeks after the intervention
Primary	SDS score	Self-Rating Depression Scale (SDS)	at 8 weeks after the intervention
Primary	BSRS-5 score	the five-item Brief Symptom Rating Scale (BSRS-5)	one day before the intervention
Primary	BSRS-5 score	the five-item Brief Symptom Rating Scale (BSRS-5)	at 6 weeks after the intervention
Primary	BSRS-5 score	the five-item Brief Symptom Rating Scale (BSRS-5)	at 8 weeks after the intervention
Primary	PSQI score	Pittsburgh Sleep Quality Index (PSQI)	one day before the intervention
Primary	PSQI score	Pittsburgh Sleep Quality Index (PSQI)	at 6 weeks after the intervention
Primary	PSQI score	Pittsburgh Sleep Quality Index (PSQI)	at 8 weeks after the intervention