Protocol summary

Summary
This study will be conducted to assess the effect of group counseling using problem-solving strategy on irrational beliefs and the efficacy of health volunteers about breast's self-awareness. This study is a random controlled trial. Forty health volunteers working at Abhar health centers will be invited to the study. The inclusion criteria are: no breast problems history, age above 18 years, having irrational beliefs about breast cancer. The exclusion criteria are: Unwillingness to participate in study, breast disease during the study, more than 2 sessions absence from counseling sessions. The participants in the intervention group will participate in group classes. The sessions will be held based on the problem-solving strategies for seven two-hour sessions (once a week). After the intervention, the questionnaires will be again completed by the participants. In control group, training session will be held in the form of lecture on "Breast cancer and screening methods". Data between the two groups will be compared after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120825431N1
Registration date: 2016-08-30, 1395/06/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-30, 1395/06/09
Registrant information
Name
Elham Shakibazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3210
Email address
shakib@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Social Determinants of Health Research Center Zanjan University of Medical Sciences
Expected recruitment start date
2015-11-03, 1394/08/12
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group counseling based on problem solving on irrational beliefs and self-efficacy of health volunteers about breast self-awareness
Public title
Effect of group counseling based on problem solving on irrational beliefs and self-efficacy of health volunteers about breast self-awareness
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: no breast problems history, age above 18 years, having irrational beliefs about breast cancer Exclusion criteria: Unwillingness to participate in study, breast disease during the study, more than 2 sessions absence from counseling sessions
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
• Azadi Boulevard, Zanjan Medical Science University's staff, Research center's third floor (Research and Technology)
City
Zanjan
Postal code
4515789589
Approval date
2015-11-03, 1394/08/12
Ethics committee reference number
zums.rec.1394.199

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
XXI
ICD-10 code description
XXI

Primary outcomes

1

Description
irrational beliefs
Timepoint
before and after the intervention
Method of measurement
questionnaires

2

Description
self-efficacy
Timepoint
before and after the intervention
Method of measurement
questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group receives the A.B.C method of problem-solving to correct irrational beliefs on breast cancer among health volunteers and enhance their self-efficacy on breast self-awareness. A indicates stimulator event (of problem), B is a belief about that event (what people say themselves), and C shows the behavioral and emotional consequences. Intervention will be held during seven consultation sessions by a trained person.
Category
Early detection

2

Description
In control group, a training session will be held about breast cancer and screening method.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center Hussain Abad
Full name of responsible person
Mahnaz Rouzbeh
Street address
Hossein Abad Street Mousavi
City
Abhar

2

Recruitment center
Name of recruitment center
Health Center 22 Bahman
Full name of responsible person
Mahnaz Rouzbeh
Street address
Street martyr Beheshti
City
Abhar

3

Recruitment center
Name of recruitment center
Health Center 17 Sharivar
Full name of responsible person
Mahnaz Rouzbeh
Street address
Street 17 Sharivar
City
Abhar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Social Determinants of Health Research Center, Zanjan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research, doctor Masoumeh Namadian
Street address
Zanjan, the highway of Sheikh Fazlullah Nuri, Vali-Asr Hospital, Institute of Metabolic Diseases, Second Floor, Center "Social Determinants of Health"
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Social Determinants of Health Research Center, Zanjan University of Medical Sciences
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
Zanjan University of Medical Sciences
Full name of responsible person
Mahnaz Rouzbeh
Position
Master of Counseling in midwifery
Other areas of specialty/work
Street address
Zanjan -Shahrak Karmandan - end street Haj Ahmad Mahdavi - School of Nursing and Midwifery
City
Zangan
Postal code
4515789589
Phone
+98 24 3527 8579
Fax
+98 33770305
Email
nursing@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Shakibazadeh
Position
PhD Health Education, Assistant Professor
Other areas of specialty/work
Street address
School of Public Health, TUMS
City
Tehran
Postal code
4515789589
Phone
+98 21 4293 3210
Fax
+98 21 4293 3072
Email
elham50sh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Shakibazadeh
Position
PhD Health Education, Assistant Professor
Other areas of specialty/work
Street address
School of Public Health. TUMS
City
Tehran
Postal code
4515789589
Phone
+98 21 4293 3210
Fax
+98 21 4293 3072
Email
elham50sh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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