Protocol summary

Summary
The present study is a before-after experimental study with a randomized control group. The aim of the study is to examine the educational intervention effect based on self-efficacy and outcome expectations on the physical activities of the women suffering from breast cancer. The population in question are the women with breast cancer and the visitors to Seyyed Alshohada Hospital and Palliative care center (with the name of “Entekhab”) in Isfahan. Inclusion criteria: (1) the final diagnosis of breast cancer by a physician, exclusion criteria: 1: therapist’s prescription for a ban on attending the sessions. 2. A lack of desire to continue to participate in the study. In order to determine the sample size, the Stevens tables were used. The sample size in each group (intervention and control) is 35 patients including the loss of 10%, i.e. 70 individuals as a whole. Data collection method: 1: the self-efficacy assessment questionnaire for physical activity and outcome expectations. 2. International physical activity questionnaire (IPAQ). The former questionnaire was completed before and one month after the educational intervention, and the latter filled out before and three months after it. The experimental group underwent the educational program within at least four ninety-minute sessions with regard to the requirement identified from the patients over four weeks, while the control group was treated by normal medical care.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014042117379N1
Registration date: 2014-09-25, 1393/07/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-25, 1393/07/03
Registrant information
Name
Rahele Solymani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 137 6746
Email address
rahelesolymani@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing self-efficacy, outcome expectations for promoting the physical activity of the women with breast cancer in two groups with and without educational program
Public title
The Physical activity of the women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. the final diagnosis of breast cancer by a physician. 2. With individual consent and their spouse consent if they are married 3. physician’s written consent to the participation of the educational program. 4. The ability to read and write the exclusion criteria: 1. the therapist’s prescription for a ban on attending the sessions, 2. a lack of desire to participate in the study, 3. the absence for more than one session during the educational sessions, 4. People who are diagnosed with cognitive disorder during the educational intervention
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The target group in question are the individuals visiting Seyyed Alshohada Hospital and the center for palliative medicine in Isfahan. The population of the target group will be then divided into the control and experimental group (in order to determine the test of the participants on odd days, and in order to determine the control group, the even days are considered

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St, Health School, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2014-01-08, 1392/10/18
Ethics committee reference number
د/12 /3082

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
c50
ICD-10 code description
50 Malignant neoplasm of breast

Primary outcomes

1

Description
self-efficacy for physical activity
Timepoint
Before the intervention and one month after it
Method of measurement
The standard self-efficacy questionnaire for physical activity by Bandura

2

Description
outcome expectation for physical activity
Timepoint
Before the intervention and one month after it
Method of measurement
the questionnaire tested

Secondary outcomes

1

Description
Physical activity
Timepoint
Before the intervention and three month after it
Method of measurement
the standard physical activity measurement questionnaire

Intervention groups

1

Description
The first session is devoted to identifying patients’ need for education in the experimental group, then they receive education during at least 4 educational ninety minute sessions with respect to the barriers of self-efficacy in physical activity, energy management, stress management, lymphedema prevention, and other topics mentioned in the group. The training sessions are presented by PowerPoint and the relevant experts for each topic. The educational activities are intended for the promotion of self-efficacy, brainstorming strategies, verbal persuasion, successor experience, framing question in the group.
Category
Rehabilitation

2

Description
There is no special arrangement for the control group, except for normal medical care
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Entekhab Supportive and Palliative care center
Full name of responsible person
Rahele Solymani
Street address
NO.29, Aminodoleh Alley, Sahid Baghi Alley, Shahid Motahari St, Isfahan, Iran
City
Isfahan

2

Recruitment center
Name of recruitment center
Seyyed Alshohada Hospital
Full name of responsible person
Rahele Solymani
Street address
Motahari Ave, Saeb St, toward Marnans Bridge, Shiris Bridge, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezar Jarib St, Vice chancellor for research, Isfahan University of Medical Sciences
City
Isfahan
Grant name
هنوز اعلام نشده است.
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Rahele Solymani
Position
Master student of Health Education and Social Health Promotion
Other areas of specialty/work
Street address
Hezar Jarib St, Health School, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2752
Fax
+98 31 3668 2509
Email
Rahelesolymani@hlth.mui.ac.ir; Raheel_s59@yahoo.com
Web page address
www.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rahele Solymani
Position
Master student of Health Education and Social Health Promotion
Other areas of specialty/work
Street address
Hezar Jarib St, Health school, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2752
Fax
+98 31 3668 2509
Email
Rahelesolymani@hlth.mui.ac.ir; raheel_s59@yahoo.com
Web page address
www.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rahele Solymani
Position
Master student of Health Education and Social Health Promotion
Other areas of specialty/work
Street address
Hezar Jarib St, Health School, Department of Health Education , Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2752
Fax
+98 31 3668 2509
Email
Rahelesolymani@hlth.mui.ac.ir; Raheel_s59@yahoo.com
Web page address
www.mui.ac.ir

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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