1. To determine the effect of mindfulness on reducing physiological responses to stress in women with breast cancer.
2. To determine the effect of mindfulness on increasing life expectancy in women with breast cancer.
3. Study to determine the relationship between changes in the neurobehavioral system and life expectancy in women with breast cancer
Design
This research is a quantitative and quasi-experimental study that uses a pretest-posttest design with a control group. In this design, two experimental and control groups are assigned by simple randomization.
Settings and conduct
In this study, 60 women with breast cancer will be randomly selected and assigned to two experimental groups (30 people) and control groups (30 people).
Participants/Inclusion and exclusion criteria
1.Women between the ages of 30 and 45.
2- Diagnosed with breast cancer by a specialist.
3- Not participating in any cognitive therapy or similar intervention program.
4- Physically and mentally capable of participating in mindfulness sessions and completing questionnaires.
5- Informed consent to participate in the study.
6- Definite diagnosis of breast cancer by a specialist (stage I to III, without metastasis).
7- Physical and mental ability to participate in group sessions and complete questionnaires.
Intervention groups
The experimental group will receive a mindfulness-based cognitive therapy intervention. The intervention will consist of 8 two-hour sessions over 4 weeks. Each session will include training in mindfulness techniques, meditation, stress reduction techniques, and coping skills.
Main outcome variables
Behavioral nervous system, life expectancy, reduction of rumination, acceptance and commitment to values, self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250825066997N1
Registration date:2025-10-07, 1404/07/15
Registration timing:prospective
Last update:2025-10-07, 1404/07/15
Update count:0
Registration date
2025-10-07, 1404/07/15
Registrant information
Name
Romina Baradaran Agh Ghaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 7467
Email address
br.romix@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-21, 1404/07/29
Expected recruitment end date
2025-11-20, 1404/08/29
Actual recruitment start date
2025-10-22, 1404/07/30
Actual recruitment end date
2025-11-20, 1404/08/29
Trial completion date
2025-11-20, 1404/08/29
Scientific title
Investigating the impact of mindfulness-based cognitive therapy (MBCT) on the neurobehavioral system and life expectancy of women with breast cancer
Public title
Investigating the impact of mindfulness-based cognitive therapy (MBCT) on the neurobehavioral system and life expectancy of women with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women between the ages of 30 and 45.
Diagnosed with breast cancer by a specialist.
Not participating in any cognitive therapy or similar intervention program.
Physically and mentally capable of participating in mindfulness sessions and completing questionnaires.
Informed consent to participate in the study.
Definite diagnosis of breast cancer by a specialist (stage I to III, without metastasis).
Physical and mental ability to participate in group sessions and complete questionnaires.
Having minimal literacy.
Not having a severe psychiatric disorder (such as schizophrenia, bipolar disorder, or substance dependence) based on medical records or self-report.
Not taking psychotropic or strong sedative medications that directly affect the neurobehavioral system (except in stable conditions and under the supervision of a physician).
Exclusion criteria:
Age
From 30 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants will be randomly assigned to the intervention and control groups in a 1:1 ratio using a simple randomization method. The random allocation sequence will be generated by an independent statistician using a computer-based random number table (Excel or SPSS). To ensure allocation concealment, the randomization sequence will be kept in sequentially numbered, opaque, sealed envelopes (SNOSE). After verifying inclusion and exclusion criteria and obtaining informed consent, the corresponding envelope will be opened, and the participant will be assigned to the designated group. The outcome assessor will be blinded to group allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Semnan Branch
Street address
Damghan road، 5th kilometer of Semnan
City
Semnan
Province
Semnan
Postal code
37111-35131
Approval date
2025-09-10, 1404/06/19
Ethics committee reference number
IR.IAU.SEMNAN.REC.1404.065
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
Behavioral nervous system
Timepoint
Before the intervention and after the intervention
Method of measurement
BRI - Behavioral Regulation Inventory
2
Description
Disappointment
Timepoint
Before the intervention and after the intervention
Method of measurement
Beck's Hopelessness Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The control group received only standard medical care during the study period and did not receive any group or individual psychotherapy intervention.
Category
Behavior
2
Description
The experimental group underwent MBCT intervention for eight sessions. The research tools included the Life Expectancy Questionnaire (BHI), the Behavioral Regulation Questionnaire (BRI), and the data were analyzed using independent and paired t-tests and Pearson correlation coefficient. The findings showed that after the intervention, the experimental group had a significant improvement in all variables compared to the control group.