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.
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.
Design
The randomized controlled trial, with parallel groups, single-blind
Settings and conduct
This study will be carried out at the Cancer Institute of Imam Khomeini Hospital. Question Prompt list will be provided to eligible patients, and finally, shared decision making, self-efficacy in decision making and Preferences in Participation will be measured. This study will be single-blind. data from two groups will be coded and delivered to the statistical analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ability to read and write Persian language, lack of history of any type of cancer, absence of mental illness that prevents participation in decision making or informed consent, age 18 and above, patient's willingness to participate in research, knowledge of breast cancer diagnosis for itself, breast cancer in a variety of invasive ductal carcinoma, invasive lobular carcinoma, mixed carcinoma; no lymphadenopathy and tumor size should be greater than 0.5; the tumor is in stages I and II, ER (estrogen receptor) and PR (progesterone receptor) are positive and HER2 (human epidermal growth factor receptor 2) is negative.
Exclusion criteria: Cancer in stages III and IV, having a history of breast cancer in the family (first-degree relatives), the patient's reluctance to continue to collaborate in research.
Intervention groups
The intervention group will receive Question prompt list(QPL) and the control group will receive the usual care. QPL is an organized list of questions that can be answered by clients who can find it from a variety of sources, such as the health team, the Internet, patients with similar conditions, and other resources.
Main outcome variables
Shared decision making
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190626044032N1
Registration date:2019-07-16, 1398/04/25
Registration timing:prospective
Last update:2019-07-16, 1398/04/25
Update count:3
Registration date
2019-07-16, 1398/04/25
Registrant information
Name
Zahra Yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 1685
Email address
z-yazdani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
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.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write the Persian language
Lack of history of any type of cancer
Absence of mental illness that prevents participation in decision making or informed consent
Age 18 and above
Patient's willingness to participate in research
Knowledge of breast cancer diagnosis For itself
Breast cancer in a variety of Invasive ductal carcinoma, Invasive lobular carcinoma, Mixed carcinoma, diagnosed with a doctor
There is no lymphadenopathy
Their tumor size should be greater than 0.5 (size tumor> 0.5 )
In pathological tests, the tumor is in stages I and II
ER (estrogen receptor) and PR (progesterone receptor) are positive and HER2 (human epidermal growth factor receptor 2) is negative
Exclusion criteria:
Cancer in stages III and IV
Having a history of breast cancer in the family (first degree relatives)
Patient's reluctance to continue to collaborate in research
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be single blind. Data from two groups will be coded and delivered to the statistical analyst.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth floor, Central Office of Tehran University of Medical Sciences, Corner of Quds St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.TUMS.VCR.REC.1398.359
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Shared decision making
Timepoint
After intervention
Method of measurement
The 9-item Shared Decision Making Questionnaire
Secondary outcomes
1
Description
Self-efficacy in Decision Making
Timepoint
Before and after intervention
Method of measurement
Decision Self-efficacy Scale
2
Description
Preferences in Participation
Timepoint
After intervention
Method of measurement
Control Preferences Scale
Intervention groups
1
Description
QPL is an organized list of questions that can be answered by clients who can find it from a variety of sources, such as the health team, the Internet, patients with similar conditions, and other resources. The intervention group, after meeting radiologist, receives the QPL, which includes questions about chemotherapy, its complications, the frequency and duration of the follow-up period. Patients will be given the opportunity to find answers to these questions from any source they desire. The time taken for QPL to make decisions is different in terms of the referral time of each patient and is measured as an auxiliary variable and controlled in statistical analysis. The researcher will respond to patient questions through a social network and will follow them up. Patients meet radiologist and share their opinion with her and the final decision is made.
Category
Other
2
Description
Control group: The control group will benefit from routine care and will not receive any interventions to help making decision .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini Hospital
Full name of responsible person
Marzieh Lashkari
Street address
Cancer Institute, Imam Khomeini Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
158-13145
Phone
+98 21 6658 1524
Email
crc@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Street address
Sixth floor, Central Office of Tehran University of Medical Sciences, Corner of Quds St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Yazdani
Position
Student of community health nursing/Master of Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nosrat St., Tohid Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Email
zy.nurse@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nosrat St., Tohid Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Email
negarandeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Yazdani
Position
Student of community health nursing/Master of Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Nosrat St., Tohid Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Email
zy.nurse@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The outcomes and basic characteristics of the participants will be shared after being unidentified.
When the data will become available and for how long
Data will be released when the results are published.
To whom data/document is available
All people will have access to published data.
Under which criteria data/document could be used
Data can be used for people who intend to write systematic review and meta-analysis.
From where data/document is obtainable
To receive the data, you can send an email to the following address:
zy.nurse@gmail.com
What processes are involved for a request to access data/document
After reviewing the request, the data will be sent by email.