Protocol summary

Summary
The purpose of this study is the effectiveness of acceptance and commitment therapy (ACT) on self-esteem and self-efficacy women with breast cancer. Breast cancer women referred to Sari Emam hospital cancer center are the population of the study in this randomized control trial. The sample of the study are 30 women with eligibility criteria. Participants radomly four block assign into control and expermental groups(15 people in each group). Inclusion criteria: women 30-50 years old; chemoterapy treatment; literacy raeding and writing. Exclusion criteria: do not participate in a maximum of one session and desire to exit from the study. The expermental group receives ACT for 8 sessions for 90 minutes once a week and individuals in control group did not receive any intervention. All participants will complete self-esteem inventory and cancer Behavior inventory(CBI) before the intervention, immediately after the intervention and one month after the intervention completion.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017062834802N1
Registration date: 2017-09-06, 1396/06/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-06, 1396/06/15
Registrant information
Name
Masomeh Daneshvar
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4208 0939
Email address
m.daneshvar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy on self-esteem and self-efficacy women with Breast cancer
Public title
The effect of counseling on self-esteem and self-efficacy women with Breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: women 30-50 years old; chemotherapy treatment; literacy reading and writing. Exclusion criteria: do not participate in a maximum of one sessions and desire to exit from the study.
Age
From 30 years old to 50 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block Randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Vice chancellor Research, Payambar Azam Complex, Basij squre, sardasht
City
Arak
Postal code
3848176941
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ARAKMU.REC.1396.35

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
Self-esteem
Timepoint
Before the intervention،immediately after intervention،one month after intervention completion
Method of measurement
Self-esteem inventory

Secondary outcomes

1

Description
Self-efficacy
Timepoint
Before the intervention،immediately after intervention،one month after intervention completion
Method of measurement
Cancer behavior inventory

Intervention groups

1

Description
Control group: no action
Category
N/A

2

Description
Intervention group: experimental group receive acceptance and commitment therapy (ACT) In 90 minutes once a week for a total of eight sessions
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari Emam hospital, Cancer center
Full name of responsible person
Masomeh Daneshvar
Street address
Sari Emam hospital
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellornfor research, Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Arak University of Medical Sciences, Payambar Azam complex, Basij square, Sardasht
City
Arak
Grant name
8310000
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellornfor research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Masomeh Daneshvar
Position
MSc Student in consultion midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Arak University of Medical Sciences, Sardasht
City
Arak
Postal code
Phone
+98 11 4208 0939
Fax
+98 81 3417 3521
Email
m.daneshvar@arakmu.ac.ir; masomeh.daneshvar69@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Kattayon Vakilian
Position
PhD in reproductive Health and faculty member
Other areas of specialty/work
Street address
Nursing and midwifery collage, Arak University of Medical Sciences, Sardasht
City
Arak
Postal code
3848176941
Phone
+98 11 4208 0939
Fax
+98 81 3417 3521
Email
cattyv2002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masomeh Daneshvar
Position
Msc student in consultation midwifery
Other areas of specialty/work
Street address
Nursing and midwifery Faculty, Arak University of Medical Sciences, Sardasht
City
Arak
Postal code
3848176941
Phone
+98 11 4208 0939
Fax
+98 81 3417 3521
Email
masomeh.daneshvar69@gmail.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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