Mindfulness Training Improves Emotions Among Female Abdominal Cancer Patients
1 other identifier
interventional
60
1 country
1
Brief Summary
We first explored the effect of mindfulness training on depression in patients with abdominal cancer. Then the effects of cognitive emotion regulation and emotional state in the training effect were examined. Sixty patients with abdominal cancer were recruited from a hospital and divided into two groups: the mindfulness group (n=30) who received a four-week mindfulness training program, and the control group (n=30) who received only one mindfulness lecture. All participants were assessed using the Mindful Attention Awareness Scale, Cognitive Emotion Regulation Strategy Questionnaire, Positive and Negative Affect Scale, and depression subscale of the Patient Health Questionnaire before and after the mindfulness training program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedMay 7, 2025
May 1, 2025
5 months
June 19, 2024
May 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The change from baseline Mindful Attention Awareness Scale at post-training
It contains 15 items in a single dimension. All of the items are rated on a 7-point Likert scale from 1 ("strongly agree") to 7 ("strongly disagree"). Higher scores reflect a higher level of trait mindfulness and awareness of the present moment.
Baseline (Day 0)/Post-training (Month 1)
The change from baseline Patient Health Questionnaire at post-training
Its depression subscale consists of 9 items. All of the items are rated on a 4-point Likert scale from 1 ("strongly disagree") to 4 ("strongly agree"). Higher scores indicate a greater level of depression.
Baseline (Day 0)/Post-training (Month 1)
The change from baseline Cognitive Emotion Regulation Questionnaire at post-training
It consists of 36 items and nine subscales. These subscales assess various strategies employed in cognitive emotion regulation, such as self-blame, blaming others, acceptance, refocus on planning, positive refocusing, rumination or focus on thought, positive reappraisal, putting into perspective, and catastrophizing. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events.
Baseline (Day 0)/Post-training (Month 1)
The change from baseline Positive and Negative Affect Scale at post-training
It contains 20 items and consists of two self-report subscales including positive emotions and negative emotions. All of the items are rated on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). The higher the score, the stronger the emotions in a certain dimension.
Baseline (Day 0)/Post-training (Month 1)
Study Arms (2)
mindfulness group
EXPERIMENTALReceived a four-week mindfulness training program.
control group
NO INTERVENTIONReceived only one mindfulness lecture over four weeks. Following the completion of the study, the control group could also undergo the same mindfulness training program if they volunteered.
Interventions
The mindfulness training program consisted of four 45-minute lessons, conducted once a week. After each lesson, participants were required to complete daily homework, which included the mindfulness exercises learned during that week for at least 30 minutes. The mindfulness training program was based on Kabat-Zinn's Mindfulness-Based Stress Reduction and Williams' Mindfulness-Based Cognitive Therapy. Additionally, specific contents of cancer-related mindfulness training were incorporated into this program, such as Anti-cancer Self-healing Power: 8 Lessons in Mindfulness-based Stress Reduction.
Eligibility Criteria
You may qualify if:
- patients with abdominal cancer; female; over 19 years old
You may not qualify if:
- a history of neurological or psychiatric illness; intellectual or speech disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zunyi Medical University
Zunyi, Guizhou, 563000, China
Study Officials
- STUDY DIRECTOR
Taiyong Bi, PhD
Zunyi Medical College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2024
First Posted
June 25, 2024
Study Start
August 1, 2024
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
May 7, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- 6/20/2024-6/20/2029
- Access Criteria
- Anonymized data can be shared upon reasonable request by the corresponding author.
only IPD used in the results publication