Clinical trial NCT06224504: Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione
Official title: Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Lung cancer
Mindfulness-Based Stress Reduction
Exercise intervention
Anxiety
Depression
Lead sponsor: Shanxi Bethune Hospital
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 44
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SAS score
timeFrame: one day before the intervention
measure: SAS score
timeFrame: at 6 weeks after the intervention
measure: SAS score
timeFrame: at 8 weeks after the intervention
measure: SDS score
timeFrame: one day before the intervention
measure: SDS score
timeFrame: at 6 weeks after the intervention
measure: SDS score
timeFrame: at 8 weeks after the intervention
measure: BSRS-5 score
timeFrame: one day before the intervention
measure: BSRS-5 score
timeFrame: at 6 weeks after the intervention
measure: BSRS-5 score
timeFrame: at 8 weeks after the intervention
measure: PSQI score
timeFrame: one day before the intervention
measure: PSQI score
timeFrame: at 6 weeks after the intervention
measure: PSQI score
timeFrame: at 8 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients with Non-Small Cell Lung Cancer
state: Shanxi
Study officials:
affiliation: Shanxi Bethune Hospital
name: Wanling Li
role: PRINCIPAL_INVESTIGATOR
References: