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IRCT20210727052000N1 IRCT 2021-08-09 Zanjan University of Medical Sciences The effect of acceptance and commitment therapy on fear of disease progression, anxiety sensitivity and quality of life in patients with breast cancer in stages 1, 2 and 3 Evaluation of Acceptance and Commitment Therapy on fear of progression and quality of life of breast cancer patients in 1 and 2 and 3 stages 2021-09-21 anticipated 80 Complete https://irct.ir/trial/57764 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In the present study, we have an intervention group and a control group that only the intervention group received acceptance and commitment-based treatment, and both of these groups receive comments before and after the intervention and 3 months after the intervention. Needless to say, treatment books will be given to both groups. The researcher suggests that at the end of the 3-month test, if the control group wishes, the intervention group treatment will be performed for them, Randomization description: In this study, in order to achieve an equal number of patients in the control group and the intervention group, the block randomization method will be used, each block will be 5 people, the reason for using this random allocation is to ensure the equal number of people in intervention and Control In this study, we will have two blocks of intervention and control, the size of each block will be 5 people. For proper blinding, random assignment of patients to groups, after patient selection, ie after interviewing patients by the researcher, for random assignment to groups, patient statistics will be given to the statistical consultant to randomly assign patients in groups. To take. EXCEL statistical software will be used for random allocation, Blinding description: The names of all patients will be given to the statistical consultant for randomization after initial selection and review of inclusion and exclusion criteria for assignment to intervention and control groups. Also, patients in both control and intervention groups will be given a treatment book after random assignment to the groups, and the control group will have all three follow-up periods as the intervention group, but only the intervention group will receive treatment based on acceptance and commitment. They will. Therefore, patients will be unaware of whether they will be in the intervention group or the control group. N/A Fear of disease progression in patients with breast cancer in stages 1, 2 and 3. Intervention 1: Intervention group: 5 sessions of 90-minute group therapy based on acceptance and commitment, which was first proposed by Dr. Hayes. (Dr. Zenozian and Dr. Patterson, with the help of the Second Supervisor Research Team and Dr. Hayes' approval of the treatment process) developed the protocol. Protocol processes include: values, cognitive fault, acceptance. There will be only 5 patients in each treatment group. Patients will attend the treatment session only once a week. Between sessions, assignments appropriate to the content of the sessions are given to patients, and at the beginning of each session, homework is reviewed. Not to mention, in each session, after 30 minutes of work, patients will have a 15-minute rest, and in each session, patients will be given masks, alcohol, biscuits and fruit juice packed with flowers. Intervention 2: Control group: will only have treatment and follow-up books without receiving acceptance and commitment-based psychotherapy. However, after 3 months of follow-up, according to the ethical principles, the patients in the control group will benefit from the treatment of the intervention group if they wish. The treatment book contains a summary of the intervention, but without any practice or presence of the therapist and without any metaphor used in the treatment sessions. The contents of the book include processes: values, cognitive fault, acceptance. Yes - There is a plan to make this available What will be shared: Except for unnecessary information that the patient does not agree to publish, the rest of the information is shared after the person is not identified. When: Access starts 6 months after the results are published To whom: Once published in articles, it can be made available to academics or therapists. Conditions: The use of information in order to fill the research gap is allowed. Where to obtain: Fatemeh Hassani Alimolk E-mail: fatima.hassani@yahoo.com How to obtain: After the articles are published, the data will be made available by the journal. Of course, the data will be available 6 months after the results are published. Comments:
public Fatemeh Hassani alimolk
Zanjan university of Medical sciences, Mahdavi street, Azadegan sector, Zanjan
Zanjan Iran (Islamic Republic of) 4513956111 +98 44 3566 1160 fatima.hassani75@yahoo.com Zanjan University of Medical Sciences scientific Fatemeh Hassani alimolk
Zanjan university of Medical sciences, Mahdavi street, Azadegan sector, Zanjan
Zanjan Iran (Islamic Republic of) 4513956111 +98 44 3566 1160 fatima.hassani75@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Age range 18 to 50 years No tumor metastasis Patients who have only had 1 to 3 sessions of chemotherapy or radiotherapy Patients must either be from Zanjan or have been staying in a guest house for at least 2 months To have Physically ability to attend sessions No psychosis disorders and personality disorders Haven't been in psychotherapy during the last month Not using psychiatric drugs No diagnosis of misue of alcohol or addictive substances Patients' satisfaction and interest in participating in the study 18 years 55 years Female Patients' dissatisfaction with continuing treatment Worsening of patients' mental or physical condition during treatment Absence of more than one session of treatment C50.011 Malignant neoplasm of nipple and areola, right female breast Rehabilitation Rehabilitation Intervention group: 5 sessions of 90-minute group therapy based on acceptance and commitment, which was first proposed by Dr. Hayes. (Dr. Zenozian and Dr. Patterson, with the help of the Second Supervisor Research Team and Dr. Hayes' approval of the treatment process) developed the protocol. Protocol processes include: values, cognitive fault, acceptance. There will be only 5 patients in each treatment group. Patients will attend the treatment session only once a week. Between sessions, assignments appropriate to the content of the sessions are given to patients, and at the beginning of each session, homework is reviewed. Not to mention, in each session, after 30 minutes of work, patients will have a 15-minute rest, and in each session, patients will be given masks, alcohol, biscuits and fruit juice packed with flowers. Control group: will only have treatment and follow-up books without receiving acceptance and commitment-based psychotherapy. However, after 3 months of follow-up, according to the ethical principles, the patients in the control group will benefit from the treatment of the intervention group if they wish. The treatment book contains a summary of the intervention, but without any practice or presence of the therapist and without any metaphor used in the treatment sessions. The contents of the book include processes: values, cognitive fault, acceptance. Score of fear of disease progression questionnaire. Timepoint: Filling in the fear questionnaire of disease progression before the intervention, after the intervention and 3 months after the intervention. Method of measurement: Dr. Hersbach's Fear of Progress Questionnaire. Quality of life questionnaire score for cancer patients. Timepoint: Filling out the quality of life questionnaire for cancer patients before the intervention, after the intervention, 3 months after the intervention. Method of measurement: Quality of life questionnaire for cancer patients. Anxiety sensitivity questionnaire score. Timepoint: Filling out the anxiety sensitivity questionnaire before the intervention, after the intervention, 3 months after the intervention. Method of measurement: Anxiety Sensitivity Questionnaire. Scale of experimental avoidance subscale of Acceptance and Practice Questionnaire. Timepoint: Admission and practice questionnaire is completed before the intervention, after the intervention, 3 months after the intervention. Method of measurement: Bond's Admission and practice questionnaire. Psychological flexibility (acceptance and practice questionnaire score). Timepoint: Admission and practice questionnaire is filled out before the intervention, after the intervention and 3 months after the intervention. Method of measurement: Bond's Acceptance and practice questionnaire. Cognitive integration (Gilders Cognitive integration questionnaire score). Timepoint: The cognitive integration questionnaire is filled out before the intervention, after the intervention and 3 months after the intervention. Method of measurement: Gilders Cognitive Integration Questionnaire. Zanjan University of Medical Sciences Approved 2021-07-24 Ethics Committee of Zanjan University of Medical Sciences Shahid Beheshti hospital, Ark gate, Zanjan city, Zanjan province Zanjan Zanjan Iran (Islamic Republic of)