Objective: determination the effect of decision aid package on selecting therapeutic option and decision outcomes in patients with early stage breast cancer. Study: RCT, parallel, not blinded, convenient sampling. Inclusion criteria: 1) Have clinical stage 1 or 2 breast cancer that be approved by the physician 2) Not have previous history of cancer. 3) Not have serious non-malignant diseases such as cardiovascular, respiratory, renal, which may prevent the definitive surgery . 4) They should be literate. Exclusion criteria: 1) If patient requires to intensive care. 2) If patient dies or migrate. 3) If patient participate in other studies. The number of patients participating in this study were 30 patients with early stage breast cancer admitted to Cancer Institute of Imam Khomeini Hospital. The patients have been randomly divided into two groups, intervention (n=15) and control (n=15) groups. The control group were received only routine care and the intervention group were received decision aid' package in addition to the usual care and were conducted for choose of one of therapeutic options mastectomy or lumpectomy with radiotherapy. Patients' follow-up by telephone was done every two weeks for eight weeks after surgery. Outcomes: therapeutic option chosen by patients, decision conflict, and decision regret, in intervention conditions in comparison with controls.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210165987N6
Registration date:2013-06-13, 1392/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-13, 1392/03/23
Registrant information
Name
Shahrzad Ghiyasvandian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shghiyas@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
International Campus, Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of decision aid package on selecting therapeutic option and decision outcomes among patients with early stage breast cancer
Public title
The effect of decision aid in patients with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: all case studies will sign an informed consent, and also they should have the following conditions: 1) Have clinical stage 1 or 2 breast cancer that be approved by the physician 2) Not have previous history of cancer. 3) Not have serious non-malignant diseases such as cardiovascular, respiratory, renal, which may prevent definitive surgery . 4) They should be literate. 5) They should have language of Persian dialects. 6) Not have mental disorder and addictions which preventing decision-making process and giving informed consent for participating in this study. Exclusion criteria: In this study, if a patient has one of following characteristics, it will be excluded from the study: 1) If patient requires to intensive care. 2) If patient dies or migrate (so that access to the patient is not possible). 3) If patient participate in other studies
Age
From 21 years old to 78 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran, Keshavarz blvd, Ghods st.
City
Tehran
Postal code
1419733171
Approval date
2012-09-30, 1391/07/09
Ethics committee reference number
130/1431/د/91
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
Select therapeutic option
Timepoint
One to four days after intervention
Method of measurement
O'Connor questionnaire
2
Description
ِِDecision conflict
Timepoint
1-4 days after intervention
Method of measurement
O'Connor traditional decisional conflict scale
Secondary outcomes
1
Description
Decision Regret
Timepoint
Eight weeks after intervention
Method of measurement
O'Connor Decision Regret Scale
Intervention groups
1
Description
Intervention 2: Intervention group at the first visit after confirm the diagnosis by physician, to get decision aid package were referred to the research nurse. Decision aid Package includes a information booklet and audiotape and personal worksheet. Information booklet contains information about the disease, treatment options, advantages and disadvantages of each treatment and the effect of treatment on patient survival and quality of life and were informed the patients for choose of one of therapeutic options (mastectomy or lumpectomy with radiation). The audiotape was twenty-minute long and supplements the booklet. And personal worksheet was in order to record the final decision and any questions, comments or ambiguity of the patients after study package. The patients were asked to return to their doctor up to four days later, after consultation with the people their trusted and study package, to discuss their questions and announce their final decision on the therapeutic option. Telephone follow-up during this period until the return of the patients to prevent the withdrawal of the samples was performed by a research nurse. On the second visit, treatment option and decision conflict questionnaire was completed. Eight weeks after beginning treatment decision regret questionnaire was completed. Patients telephone follow-up was done every two weeks during this eight weeks.
Category
Other
2
Description
Intervention 2: The control group were received routine care. Decision aid package was not given to this group. One to four days after the first visit (before beginning treatment) treatment option and decision conflict questionnaire was completed and eight weeks after treatment, decision regret questionnaire was completed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini Hospital
Full name of responsible person
Seyyede Narjess Mousavizade
Street address
Tehran, Tohid Sq, Nosrat Street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of Nursing and Midwifery, Tehran University of Medical Science
Full name of responsible person
Doctor Ziba Taghizade
Street address
Tehran, Tohid sq, Faculty of nursing and midwifery, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Faculty of Nursing and Midwifery, Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
International Campus, Tehran University of Medical Sciences
Full name of responsible person
Seyyede Narjess Mousavizade
Position
Master of Nursing
Other areas of specialty/work
Street address
Tehran, Tohid sq, Nosrat street, Faculty of nursing and midwifery, Tehran University of Medical Science
City
Tehran
Postal code
Phone
+98 21 6637 7579
Fax
Email
mousavi201089@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Shahrzad Ghiyasvandiyan
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran, Tohid sq, Faculty of nursing and midwifery,Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6642 0739
Fax
Email
shghiyas@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
International Campus of Tehran University of Medical Sciences
Full name of responsible person
Syyede Narjess Mousavizade
Position
Master of Nursing
Other areas of specialty/work
Street address
Tehran, Tohid sq, Nosrat street, Faculty of nursing and midwifery, University of Tehran
City
Tehran
Postal code
Phone
+98 21 6637 7579
Fax
Email
mousavi201089@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)