Protocol summary
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Study aim
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The Effect of Using the Question Prompt List on Self-efficacy in Decision Making, Preferences in Participation and Shared Decision Making among People with Breast Cancer.
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Design
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The randomized controlled trial, with parallel groups
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Settings and conduct
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This study was carried out at the Cancer Institute of Imam Khomeini Hospital. Question Prompt list was provided to eligible patients, and finally, shared decision making, decision self-efficacy, and Preferences for participation were measured. Data, from two groups, was coded and delivered to the statistician.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients with breast cancer who were referred for adjuvant/ neoadjuvant treatment following tumor resection, knowing their diagnosis of breast cancer, able to read and write Persian; and age 18 years or older
Exclusion criteria: a history of psychiatric illness that would prevent them from participating in treatment decision-making, metastatic breast cancer, and reluctance to participate in research
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Intervention groups
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The intervention group benefited from the QPL and the control group received routine care. The QPL was an organized list of questions that clients could ask their answers at the next appointment with their physician or answer through the WhatsApp messenger, Soroush, And Eita. Patients were followed up during that time and their questions were answered.
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Main outcome variables
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Shared decision making
General information
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Reason for update
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This is a single-blind study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190626044032N1
Registration date:
2019-07-16, 1398/04/25
Registration timing:
prospective
Last update:
2021-02-03, 1399/11/15
Update count:
3
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Registration date
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2019-07-16, 1398/04/25
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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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2019-07-23, 1398/05/01
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Expected recruitment end date
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2019-12-22, 1398/10/01
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Actual recruitment start date
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2019-09-23, 1398/07/01
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Actual recruitment end date
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2020-11-14, 1399/08/24
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Trial completion date
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2020-11-14, 1399/08/24
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Scientific title
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The Effect of Using the Question Prompt List on Self-efficacy in Decision Making, Preferences in Participation and Shared Decision Making among People with Breast Cancer.
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Public title
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The Effect of Using the Question Prompt List on Self-efficacy in Decision Making, Preferences in Participation and Shared Decision Making among People with 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:
able to read and write Persian
patients with breast cancer who were referred for adjuvant/ neoadjuvant treatment following tumor resection
age 18 years or older
knowing their diagnosis of breast cancer
Exclusion criteria:
a history of psychiatric illness that would prevent them from participating in treatment decision-making,
metastatic breast cancer,
reluctance to participate in research
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Age
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From 18 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:
50
Actual sample size reached:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The random allocation will include three steps: Random sequence generation, allocation concealment and doing a random allocation process. Four random blocks are used to generate random sequences. Random sequence generation by block method will be done using Random Allocation Software. To ensure that random sequence is not predictable for the researcher who will perform the sampling, allocation concealment will be performed using numbered, sealed, opaque envelopes. These two steps are taken by the supervisor and the student who performs the sampling will not be involved in these two phases.
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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 data were coded and delivered to a statistician.
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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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2019-06-26, 1398/04/05
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.359
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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Shared decision making
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Timepoint
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After intervention
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Method of measurement
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The 9-item Shared Decision Making Questionnaire
Secondary outcomes
1
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Description
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Self-efficacy in Decision Making
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Timepoint
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Before and after intervention
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Method of measurement
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Decision Self-efficacy Scale
2
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Description
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Preferences in Participation
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Timepoint
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Before and after intervention
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Method of measurement
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Control Preferences Scale
Intervention groups
1
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Description
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The intervention group received QPLs with questions about chemotherapy, radiotherapy, or a combination of both, depending on what the patient needed. The time taken for QPL to make decisions was different in terms of the referral time of each patient and was measured as an auxiliary variable. The researcher responded to patient questions through a social network and followed them up. Patients met radiologist and shared their opinion with her and the final decision was made.
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Category
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Other
2
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Description
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Control group: The control group benefited from routine care and did not receive any intervention to help making decision .
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Category
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N/A
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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Tehran 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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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not 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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The outcomes and basic characteristics of the participants will be shared after being unidentified.
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When the data will become available and for how long
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Data will be released when the results are published.
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To whom data/document is available
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All people will have access to published data.
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Under which criteria data/document could be used
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Data can be used for people who intend to write systematic review and meta-analysis.
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From where data/document is obtainable
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To receive the data, you can send an email to the following address:
zy.nurse@gmail.com
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What processes are involved for a request to access data/document
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After reviewing the request, the data will be sent by email.
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Comments
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