Objective: The effectiveness of acceptance and commitment therapy base on fear from recurrence of cancer and posttraumatic growth in patients with breast cancer.
Study design: Random (random numbers schedule), without placebo control, single central.
Experimental population: 20 patients with breast cancer who referred to relief Society for cancer patients Koomesh Semnan.
Inclusion criteria: Cancer detection by oncologist; at least education to middle school.
Exclusion criteria: Patients who have concurrent medical disorders; patients are undergoing another psychotherapy at the same time; patients who have severe disease or another cancer.
Sample size, intervention, intervention time and outcome of study: Sample size of this study is 20 persons will be divided into intervention and control groups.
Intervention group: Treatment sessions based on Acceptance and Commitment Therapy book of Hayes, Strosahl, & Wilson will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment.
Control group: In the control group (10 persons) will not performed any intervention just the results compared with experimental group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062225732N19
Registration date:2017-07-02, 1396/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-02, 1396/04/11
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
Semnan University of Medical Sciences
Expected recruitment start date
2016-04-18, 1395/01/30
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of adherence treatment and commitment to fear from a recurrence of cancer and post-traumatic growth in patients with breast cancer.
Public title
The efficacy of adherence treatment and commitment to fear from a recurrence of cancer and post-traumatic growth in patients with breast cancer.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Cancer detection by oncologist; at least education to middle school.
Exclusion criteria: Patients who have concurrent medical disorders; patients are undergoing another psychotherapy at the same time; patients who have severe disease or another cancer.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
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, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.SEMUMS.REC.1395.234
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
Fear of cancer recurrence
Timepoint
The middle of treatment, after treatment and two months after the end of treatment
Method of measurement
Questionnaire fear of cancer recurrence
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group (10 persons) will not performed any intervention just the results compared with experimental group.
Category
Behavior
2
Description
Intervention group: Treatment sessions based on Acceptance and Commitment Therapy book of Hayes, Strosahl, & Wilson will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Relief Society for Cancer Patients Koomesh Semnan
Full name of responsible person
Eshagh Rahimian
Street address
17 Shahrivar Blvd, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Deputy of Research and Technology
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Deputy of Research and Technology
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
Semnan University
Full name of responsible person
Eshagh Rahimian
Position
PhD in Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Eshagh Rahimian
Position
PhD in Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Eshagh Rahimian
Position
PhD in Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)