Study of the Effectiveness of Motivational interviewing on self-efficacy, treatment adherence, post-surgical adjustment with mastectomy and serum level of CEA tumor marker in Breast Cancer Patients
Study of the Effectiveness of Motivational interviewing on self-efficacy, treatment adherence, post-surgical adjustment with mastectomy and serum level of CEA tumor marker in Breast Cancer Patients
Design
randomized (Packed envelope method), without placebo control, single arm trial. The sample size of this study is 60 individuals: divided into 2 groups of 30 people.
Settings and conduct
The self-efficacy scale for self-management of breast cancer (SESSM-B) (Lee et al., 2012).
Department of Oncology, Kowsar Hospital in Semnan.
Participants/Inclusion and exclusion criteria
Women older than 18 years with the diagnosis of breast cancer at the Kowsar Hospital in Semnan province.
Inclusion criteria: Women older than 18 years; diagnosis of breast cancer, Grade 2 or 3 has been received by an oncologist and performed mastectomy and period of chemotherapy; she has not previously been involved in psychological interventions or not receiving psychotherapy by another psychologist or psychiatrist.
Exclusion criteria: Dissatisfied to participate in the study.
Intervention groups
Control group: Only for comparison with intervention group, no treatment is performed.
Intervention group: In intervention group, motivational interviewing according to the protocol individually and by the researcher for patients will be performed during 5 sessions (1 session per week).
Also blood samples from both groups will be taken before and after psychological intervention to assess the CEA serum level.
Main outcome variables
CEA tumor marker.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N29
Registration date:2018-02-04, 1396/11/15
Registration timing:registered_while_recruiting
Last update:2018-02-04, 1396/11/15
Update count:0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-18, 1396/07/26
Expected recruitment end date
2018-04-14, 1397/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effectiveness of Motivational interviewing on self-efficacy, treatment adherence, post-surgical adjustment with mastectomy and serum level of CEA tumor marker in Breast Cancer Patients
Public title
Study of the Effectiveness of Motivational interviewing on self-efficacy, post-surgical adjustment with mastectomy in Breast Cancer Patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women older than 18 years
Diagnosis of breast cancer, Grade 2 or 3 has been received by an oncologist and performed mastectomy and period of chemotherapy
She has not previously been involved in psychological interventions or not receiving psychotherapy by another psychologist or psychiatrist
Exclusion criteria:
Dissatisfied to participate in the study
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: randomized blocks.
Random unit: Individual.
Randomization Tool: Table of random numbers.
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
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.SEMUMS.REC.1396.113
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
CEA tumor marker.
Timepoint
Before and after the intervention
Method of measurement
Blood Test.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group, motivational interviewing according to the protocol individually and by the researcher for patients will be performed during 5 sessions (1 session per week).
Category
Treatment - Other
2
Description
Control group: Only for comparison with intervention group, no treatment is performed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Eshagh Rahimian
Street address
Kowsar Hospital, Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maziar Ahmadi
Street address
Islamic Azad University of Gorgan Branch, Student Street, Shahid Kalantari Blvd, Gorgan.
City
Gorgan
Province
Golestan
Postal code
4914739975
Phone
+98 17 3215 3000
Email
ahmadi.golsefidi@iran.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Eshagh Rahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Eshagh Rahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rosa Salehian
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Gorgan Branch, Student Street, Shahid Kalantari Blvd, Gorgan.
City
Gorgan
Province
Golestan
Postal code
4914739975
Phone
+98 17 3215 3000
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available