Study the effect of acceptance and commitment therapy on sexual self-esteem, sexual function, and concern for physical imaging in women with breast cancer
Investigation the effect of acceptance and commitment therapy on sexual self-esteem, sexual function, and concern for physical imaging in women with breast cancer
Design
This study is a non-blinded clinical trial. The research population will be included of all patients referring to the Taleghani hospital in Kermanshah city. 40 eligible patients will be selected conveniently and randomly assigned to intervention and control groups.
Settings and conduct
The study, which will be conducted at Taleghani hospital in Kermanshah city, is non- blinded one. Before the beginning of the study and at the end of the study, the questionnaires will be provided for both groups and the two groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of breast cancer by oncology specialist; Being married
Exclusion criteria: Simultaneously receive other psychological treatments; Patients who failed to attend at least two treatment session
Intervention groups
The intervention group will receive group commitment training, 8 sessions for 90 minutes (weekly one session).
The control group will receive group stress management training 8 sessions for 90 minutes (weekly one session).
Main outcome variables
Sexual self-esteem; Sexual function; Body image
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N96
Registration date:2018-08-01, 1397/05/10
Registration timing:prospective
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-11, 1397/05/20
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of acceptance and commitment therapy on sexual self-esteem, sexual function, and concern for physical imaging in women with breast cancer
Public title
Investigating the Effect of Acceptance and Commitment Therapy on Women with Breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of breast cancer by oncology specialist
Lumpectomy
literacy more than middle school
Being married
Exclusion criteria:
Simultaneously receive other psychological treatments; Patients who failed to attend at least two session
Patients who failed to attend at least two treatment session
Age
From 20 years old to 50 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
Randomly Individually by random number table via code receipt
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
ir.kums.rec.1397.089
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.8
ICD-10 code description
Malignant neoplasm of overlapping sites of breast
Primary outcomes
1
Description
Sexual self-esteem
Timepoint
Before beginning the study and at the end of the study
Method of measurement
Based on Women's Sexual Self-Esteem Questionnaire (SSEL-W-SF)
2
Description
Sexual function
Timepoint
Before beginning the study and at the end of the study
Method of measurement
Base on Female Sexual Function Index(FSFI)
3
Description
Body image concern
Timepoint
Before beginning the study and at the end of the study
Method of measurement
Based on the body image concern questionnaire(BICI)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive group commitment training, 8 sessions for 90 minutes (weekly one session).
Category
Lifestyle
2
Description
The control group will receive group stress management training 8 sessions for 90 minutes (weekly one session).
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Marziyeh Parvin
Street address
Shahid Beheshti Blvd., Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
m.parvin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Marziyeh Parvin
Position
MSc student of clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Kasra Street
City
Kermanshah
Province
Kermanshah
Postal code
6718997551
Phone
+98 83 3724 3181
Email
m.parvin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Mozafar Aznab
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6309
Email
draznab@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Marziyeh Parvin
Position
MSc student of clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Kasra Street
City
Kermanshah
Province
Kermanshah
Postal code
6718997551
Phone
+98 83 3724 3181
Email
m.parvin@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail