Protocol summary
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Study aim
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The effect of Mindfulness Based Stress Reduction (MBSR) on hope and spirituality well-being of women with breast cancer
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Design
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The sample of this study included 68 breast cancer patients selected from patients at Tabriz Hospitals and randomly allocated into two groups: MBSR group (n=34) and usual care, waitlist group (n=34).
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Settings and conduct
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After the randomization, participants will respond to the informed consent form. Patients in the intervention condition will receive a modified MBSR program for 8 sessions. Prior to performing the intervention, both experimental and control groups will complete the research questionnaires, and after completing 8 sessions of mindfulness training, they will respond to the questionnaires again. The project will be conducted in the oncology department of Tabriz Shahid Madani Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: (a) oncologist approved clinical diagnosis of stage I to IV breast cancer; (b) receiving the usual cancer interventions, (c) between 20 to 60 years of age, (d) having at least a high school diploma or equivalent.
Exclusion criteria: (a) other chronic diseases; (b) experience practicing yoga and/or meditations; and (c) a history of alcohol, drug and substance abuse, personality disorders, dementia, and/or developmental disorders
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Intervention groups
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Experimental group will have mindfulness based stress reduction and control group were requested to refrain from taking part in any type of Mindfulness-Based Interventions or from participating in any meditations during the trial period. Patients in the waitlist group (control) were invited to take part in the 8-week MBSR program administered by the research team after the study period.
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Main outcome variables
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-Spiritual well-being
- Hope
General information
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Reason for update
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During the recruitment process, the hospital authorities allowed us to have a larger number of patients, and we increased the sample size to increase the generalizability of the findings. We also changed some of the eligibility criteria and outcomes.
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Acronym
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MBSR
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IRCT registration information
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IRCT registration number:
IRCT20171203037729N1
Registration date:
2018-01-02, 1396/10/12
Registration timing:
prospective
Last update:
2022-05-28, 1401/03/07
Update count:
1
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Registration date
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2018-01-02, 1396/10/12
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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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2019-09-03, 1398/06/12
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Expected recruitment end date
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2019-12-29, 1398/10/08
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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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The effect of Mindfulness Based Stress Reduction (MBSR) hope and spirituality well-being of women with breast cancer
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Public title
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mindfulness based stress reduction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Oncologist approved clinical diagnosis of stage I to IV breast cancer
Receiving the usual cancer interventions
Between 20 to 60 years of age
having at least a high school diploma or equivalent
Exclusion criteria:
Other chronic diseases
Experience practicing yoga and/or meditations
History of alcohol, drug and substance abuse, personality disorders, dementia, and/or developmental disorders
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Age
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From 20 years old to 60 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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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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- Block randomization
- A list of random numbers generated by SPSS (version 24, SPSS Inc, Chicago, IL)
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The assessors of the outcome
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Placebo
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Not used
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Assignment
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Other
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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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2017-11-18, 1396/08/27
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Ethics committee reference number
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IR.TBZMED.REC.1396.719
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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C00-D48
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ICD-10 code description
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سرطان سینه
Primary outcomes
1
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Description
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Hope
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Timepoint
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Measurement of hope at the beginning of the study (before the intervention) and 2 months after intervention
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Method of measurement
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The Snyder Hope Scale (SHS)
2
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Description
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Spiritual well-being
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Timepoint
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Measurement of spiritual well-being at the beginning of the study (before the intervention) and 2 months after intervention
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Method of measurement
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Spiritual Well Being Scale (SWBS)
Intervention groups
1
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Description
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Experimental group: This group underwent MBSR for two months.A qualified therapist, who has basic professional training in mindfulness-based intervention with ten years of experience in conducting mindfulness-based programs, implemented the MBSR program. Control group: The control group were requested to refrain from taking part in any type of Mindfulness-Based Interventions. These patients were invited to take part in the 8-week MBSR program after the study period.
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Category
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Treatment - Other
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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Tabriz University of Medical Sciences
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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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Public
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data is publishable after being unidentifiable
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When the data will become available and for how long
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6 month after publication
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To whom data/document is available
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for all researchers
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Under which criteria data/document could be used
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For use in other research work
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From where data/document is obtainable
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University of Tabriz-Department of Psychology- Prof. Rasoul Heshmati-09198260681 Email: psy.heshmai@gmail.com
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What processes are involved for a request to access data/document
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Requesting from researcher and sending it by post or e-mail
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Comments
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