NCT06473636

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

June 19, 2024

Last Update Submit

May 2, 2025

Conditions

Keywords

mindfulness training; abdominal cancer patients

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

EXPERIMENTAL

Received a four-week mindfulness training program.

Behavioral: Mindfulness training

control group

NO INTERVENTION

Received 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.

mindfulness group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Taiyong Bi, PhD

    Zunyi Medical College

    STUDY DIRECTOR

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

only IPD used in the results publication

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.

Locations