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IRCT20260522069490N1 IRCT 2026-06-13 Azad University Of Marvdasht The effect of mindfulness and cognitive behavioral therapy on anxiety, body image, and psychological growth in cancer survivors The effectiveness of mindfulness-integrated cognitive behavioral therapy on fear of cancer recurrence, body image, and post-traumatic growth among breast cancer survivors 2026-06-22 anticipated 30 Complete https://irct.ir/trial/90342 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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, 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. N/A Breast Cancer Survivors. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: 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: 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. Conditions: Data will be used exclusively for non commercial secondary analyses within approved scientific purposes. Any further dissemination will require prior written approval. Where to obtain: Requests should be submitted via the principal investigator’s email. Following scientific and ethical review, approved applicants will receive encrypted de-identified datasets. How to obtain: 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.
public Dr. Mohsen Arefian
Jahrom University, Jahrom, Fars province, Iran
Jahrom Iran (Islamic Republic of) 7414785318 +98 71 5437 2000 M.arefian92@gmail.com Jahrom University scientific Dr. Mohsen Arefian
Jahrom University, Fars province, Iran
Jahrom Iran (Islamic Republic of) 7414785318 +98 71 5437 2000 M.arefian92@gmail.com Jahrom University Iran (Islamic Republic of) 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 18 years 50 years Female 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 Behavior Other 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. 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. 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). Body image. Timepoint: Baseline and post intervention following eight sessions. Method of measurement: Body Image Concern Inventory (BICI);. Post traumatic growth in cancer survivors. Timepoint: Baseline and post intervention following eight sessions. Method of measurement: Posttraumatic Growth Inventory. Azad University Of Marvdasht Approved 2026-06-08 Research Ethics Committee, Islamic Azad University, Marvdasht Branch Islamic Azad University, Marvdasht Branch, Kilometer 3, Takht-e Jamshid Boulevard, Marvdasht, Fars Province, Iran Marvdasht Fars Iran (Islamic Republic of)