The effectiveness of mindfulness-integrated cognitive behavioral therapy on fear of cancer recurrence, body image, and post-traumatic growth among breast cancer survivors
To evaluate the effectiveness of mindfulness integrated cognitive behavioral therapy on fear of cancer recurrence, body image, and post traumatic growth in cancer survivors
Design
Randomized controlled trial with parallel group design. Total sample size 30 participants. Individual random allocation with allocation concealment.
Settings and conduct
The intervention will be delivered as eight sessions of MiCBT for the intervention group at Motahari Clinic, Shiraz. Data will be collected at baseline and post intervention using standardized questionnaires.
Participants/Inclusion and exclusion criteria
Female cancer survivors; age 18 to 50 years; at least 6 months post treatment; literacy in Persian; no severe psychiatric disorders; no concurrent psychological treatment
Intervention groups
MiCBT intervention group and a no intervention control group
Main outcome variables
Fear of cancer recurrence; body image; post-traumatic growth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260522069490N1
Registration date:2026-06-13, 1405/03/23
Registration timing:prospective
Last update:2026-06-13, 1405/03/23
Update count:0
Registration date
2026-06-13, 1405/03/23
Registrant information
Name
Negin Sabetkish
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 0505
Email address
negin.sabetkishhh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2026-08-16, 1405/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-integrated cognitive behavioral therapy on fear of cancer recurrence, body image, and post-traumatic growth among breast cancer survivors
Public title
The effect of mindfulness and cognitive behavioral therapy on anxiety, body image, and psychological growth in cancer survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female breast cancer survivors
Age 18–50 years
At least 6 months after completion of primary cancer treatment (surgery, chemotherapy, or radiotherapy)
Ability to read and write Persian
No current participation in structured psychological interventions
No severe psychiatric disorders (based on clinical interview or medical history)
Willingness to participate and signed informed consent
Exclusion criteria:
Diagnosis of severe psychiatric disorders (e.g., psychotic disorders or bipolar I disorder)
Severe cognitive impairment or neurological disorders affecting participation
Current substance or alcohol dependence
Unstable or acute medical conditions during study period
Inability to attend intervention sessions regularly (e.g., more than 2 missed sessions)
Withdrawal of consent at any stage of the study
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization (simple)
Participants will be randomly assigned to either the MiCBT intervention group or the control group using a simple randomization method (e.g., computer-generated random numbers or drawing lots). Each participant will be allocated to a group without any systematic order.
To prevent prediction of group assignment, the allocation sequence will not be disclosed to the researcher in advance.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a randomized controlled trial with two parallel arms. After enrollment, participants will be randomly assigned to either the MICBT intervention group or the control group. Outcomes including fear of cancer recurrence, body image, and post-traumatic growth will be assessed at baseline and after the intervention. The intervention will be delivered through structured psychotherapy sessions, while the control group will not receive the specific intervention. Data will be collected using standardized self-report questionnaires.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee, Islamic Azad University, Marvdasht Branch
Street address
Islamic Azad University, Marvdasht Branch, Kilometer 3, Takht-e Jamshid Boulevard, Marvdasht, Fars Province, Iran
City
Marvdasht
Province
Fars
Postal code
7371113119
Approval date
2026-06-08, 1405/03/18
Ethics committee reference number
IR.IAU.M.REC.1405.180
Health conditions studied
1
Description of health condition studied
Breast Cancer Survivors
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of cancer recurrence
Timepoint
Baseline and post intervention following eight sessions
Method of measurement
Fear Of Cancer Recurrence Inventory (FCRI), Depression Anxiety Stress Scale(DASS-21)
Secondary outcomes
1
Description
Body image
Timepoint
Baseline and post intervention following eight sessions
Method of measurement
Body Image Concern Inventory (BICI);
2
Description
Post traumatic growth in cancer survivors
Timepoint
Baseline and post intervention following eight sessions
Method of measurement
Posttraumatic Growth Inventory
Intervention groups
1
Description
Intervention group: Participants in this group will receive Mindfulness Integrated Cognitive Behavioral Therapy (MiCBT). The intervention consists of eight structured group sessions. The sessions include mindfulness training, identification and modification of dysfunctional thoughts, emotion regulation exercises, and related homework assignments. Sessions will be conducted weekly in an outpatient clinical setting.
Category
Behavior
2
Description
Control group: Participants in this group will not receive any structured psychological intervention and will only be assessed at baseline and post intervention. Usual care will be allowed if required.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Mohsen Arefian
Street address
Motahari Clinic, Karim Khan Zand Boulevard, Shiraz, Fars Province, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۷۱۴۷۳۷
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad University Of Marvdasht
Full name of responsible person
Ahmadreza Oji Nezhad
Street address
Islamic Azad University, Marvdasht Branch, Marvdasht, Fars Province, Iran
City
Marvdasht
Province
Fars
Postal code
7371113119
Phone
+98 917 918 2372
Email
aoji62@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University Of Marvdasht
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University
Full name of responsible person
Dr. Mohsen Arefian
Position
Assistant Professor, Jahrom University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jahrom University, Jahrom, Fars province, Iran
City
Jahrom
Province
Fars
Postal code
7414785318
Phone
+98 71 5437 2000
Email
M.arefian92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University
Full name of responsible person
Dr. Mohsen Arefian
Position
Assistant Professor, Jahrom University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Jahrom University, Fars province, Iran
City
Jahrom
Province
Fars
Postal code
7414785318
Phone
+98 71 5437 2000
Email
M.arefian92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Negin Sabetkish
Position
M.Sc. Student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 335, 6/9 Alley, Farmandari, Sanaye St.
City
Shiraz
Province
Fars
Postal code
7196744699
Phone
+98 71 3623 0505
Email
negin.sabetkishhh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data include participants’ demographic characteristics, scores from from the Fear of Cancer Recurrence Inventory (FCRI), Body Image Concern Inventory (BICI), Posttraumatic Growth Inventory, and the DASS-21 questionnaire, and pre and post intervention evaluation data. The anonymized dataset will be available for research purposes after removal of identifiable information.
When the data will become available and for how long
Data will be made available one year after completion of final analysis and publication of results and will remain accessible for 5 years.
To whom data/document is available
Access will be restricted to researchers affiliated with recognized academic or research institutions with clear scientific objectives. Non academic or commercial requests will not be considered.
Under which criteria data/document could be used
Data will be used exclusively for non commercial secondary analyses within approved scientific purposes. Any further dissemination will require prior written approval.
From where data/document is obtainable
Requests should be submitted via the principal investigator’s email. Following scientific and ethical review, approved applicants will receive encrypted de-identified datasets.
What processes are involved for a request to access data/document
Requests will be evaluated by the research team. Upon approval, data will be shared within 45 working days. A data access agreement may be required.
Comments
All data will be fully de-identified and no sensitive personal information will be disclosed.