Protocol summary
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Study aim
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Determining the effectiveness of group consulting based on meta-cognitive therapy on anxiety, depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors.
Determining the effectiveness of group counseling based on transpersonal therapy on anxiety, depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors.
Comparison the effectiveness of group consulting based on meta-cognitive therapy and interpersonal therapy on anxiety and depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors.
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Design
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Parallel randomized single blind controlled clinical trial.
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Settings and conduct
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After screening patients who had completed their treatments, 36 patients will be randomized into 3 groups using simple randomization. Then, 2 groups will receive meta cognitive and trans personal interventions, separately. Data collectors and data analyzers are unaware of the interventions
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Participants/Inclusion and exclusion criteria
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Pathology examination with definitive diagnosis of breast cancer
Total accomplishment of breast cancer treatment
Having no medical history of psychiatric diseases
Using no psychiatric medications
Using no alternative methods of treatments such as yoga and meditation
Not attending in classes similar with the present intervention
Having informed consent to participate in the study
Exclusion criteria:
Patients during treatment
Absence for two consecutive sessions
Lack of desire to continue participating in the research
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Intervention groups
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Counseling sessions will be conducted in 14 sessions of 2 hours for participants in tow intervention group. Also, Control group will be performed for participants.
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Main outcome variables
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Coping strategies, Fear of recurrence, Quality of Life, Anxiety and depression, Hope
General information
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Reason for update
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Increase study results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200422047170N1
Registration date:
2020-06-20, 1399/03/31
Registration timing:
prospective
Last update:
2020-12-22, 1399/10/02
Update count:
1
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Registration date
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2020-06-20, 1399/03/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2023-06-22, 1402/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effectiveness of group consulting based on meta-cognitive therapy and trans-personal therapy on coping strategies ، fear of recurrence and resilience, quality of life, anxiety, depression, hope in breast cancer survivors
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Public title
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Effect of psychotherapy on the side effects of breast cancer
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pathology examination with definitive diagnosis of breast cancer
Total accomplishment of breast cancer treatment
local residency in Tehran and suburb
Have ability to participate in meta-cognitive and trans-personal classes
Having no medical history of psychiatric diseases
Using no psychiatric medications
Using no alternative methods of treatments such as yoga and meditation
Not attending in classes similar with the present intervention
Having informed consent to participate in the study
Exclusion criteria:
Patients who are during their treatment
Absence for two consecutive sessions
Lack of desire to continue participating in the research
The incidence of in-situ metastasis (carcinoma in-situ) in patients
Patients who out of access during the intervention
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Age
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From 25 years old to 70 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Breast cancer survivors are invited to participate in several medical centers after complete treatment. Then, at the first visit to the follow-up clinic, those who completed the informed consent are registered and randomly assigned to one of the three study groups, with using a table of random numbers.
Use of random numbers table
Individual randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In general, this study will be blinded to individuals who are participated in data collection, outcome assessment and data analyzing, which means that they will not be aware of the intervention and the control groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-01-12, 1398/10/22
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Ethics committee reference number
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IR.KHU.REC.1398.057
Health conditions studied
1
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Description of health condition studied
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Breast Cancer
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ICD-10 code
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C50
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ICD-10 code description
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Malignant neoplasm of breast
Primary outcomes
1
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Description
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Coping strategies ,fear of recurrence, quality of life, anxiety& depression, hope
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Timepoint
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Before the intervention, and at the end of the intervention and 2 months later, 4 months later, 8 month later,12 months later
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Method of measurement
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Coping strategies, cancer recurrence , Quality of Life Eortc30, Br23, HASD Anxiety and Depression, Beck Depression, Life expectancy Questionnaire
2
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Description
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Resilience
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Timepoint
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Before the intervention, and at the end of the intervention and 2 months later, 4 months later, 8 month later,12 months later
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Method of measurement
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Resilience Questionnaire
Secondary outcomes
1
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Description
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Mean square of coping, mean square of fear of recurrence, mean square of quality of life, mean square of anxiety and depression, mean square of life expectancy.
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Timepoint
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Before , after intervention and 2 month, 4month, 8month,12month later.
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Method of measurement
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Questionnaire
2
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Description
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Resilience
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Timepoint
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Before , after intervention and 2 month, 4month, 8month,12month later.
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention Group 1: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to a receive counseling group based on meta cognitive therapy for 14 sessions. Questionnaires of coping strategies, and fear of recurrence, quality of life, anxiety and depression, hope will be filled out before and after the intervention and after 2,4,8,12 months of follow-up. The information will then be entered into the software and data analysis will be performed and reported.
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Category
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Behavior
2
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Description
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Intervention Group 1: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to a receive counseling group based on meta cognitive therapy (including spiritual therapy, meditation and yoga) for 14 sessions. Questionnaires of coping strategies, and fear of recurrence, quality of life, anxiety and depression, hope will be filled out before and after the intervention and after 2,4,8,12 months of follow-up. The information will then be entered into the software and data analysis will be performed and reported.
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Category
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Behavior
3
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Description
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Control group: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to the control group for 14 sessions. Questionnaires of coping strategies, and fear of recurrence ,quality of life, anxiety and depression, hope will be filled out before and after the intervention in two intervention group, and after 2,4,8,12 months later. The information will then be entered into the software and data analysis will be performed and reported. They will be explained that they are in the control group and no intervention will be made for this group. However, if they wish to have counseling sessions, they will have them after accomplishment of the interventions and follow-up process.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iranian academic center for education culture and research
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available