The purpose of this study is to investigate the effectiveness of problem-solving therapy for psychological well-being in women affected by breast cancer. The study is a clinical trial, which is done on 38 women affected by breast cancer. Inclusion criteria: patients who are older than 18 years old, aware of their disease, have finished middle school at least; and at least 6 month has passed from definite diagnosis of their disease, and the result of their psychological well-being test is 2SD less than the mean. Exclusion criteria: having a history of mental problems, being affected by cognitive disorders such as delirium, dementia, taking antipsychotic medications, being affected by impaired cognitive performance and suffering from psychological disorders, suffering from other serious physical problems or other types of cancer simultaneously, being addicted to drugs. The data is collected using Ryff Psychological Well being Questionnaire. The participants who achieve the minimum score are divided into intervention and control groups: each group includes 19 participants. The author offers the intervention group weekly ninety-minute sessions of problem-solving therapy for 8 weeks. After completing counseling course and one month later, both groups will complete Ryff Psychological Well being Questionnaire again. The main outcome in this study is psychological well being.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011431940N1
Registration date:2017-03-28, 1396/01/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-28, 1396/01/08
Registrant information
Name
Elham Taeidi
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 903 564 1795
Email address
taeidi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Problem-Solving Therapy on Psychological Wellbeing in Breast Cancer Patients
Public title
Effect of Problem-Solving on Psychological Well-being
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who are older than 18 years old and are aware of their disease; have finished middle school at least, and at least 6 month from definite diagnosis; the result of their psychological wellbeing test is 2SD less than the mean. Exclusion criteria: having a history of mental problems; being affected by cognitive disorders such as delirium or dementia; taking antipsychotic medications; being affected by impaired cognitive performance who are suffering from psychological disorders; suffering from simultaneous serious physical problems or other types of cancer; being addicted to drugs (drug abuser).
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Not 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 of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jondi shapoor University
City
Ahvaz
Postal code
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR.AJUMS.REC. 1395 .589
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
Psychological Wellbeing
Timepoint
Before intervention, immediately after intervention, one month after intervention
Method of measurement
Ryff Psychological Wellbeing Questionnaire
Secondary outcomes
1
Description
Personal growth
Timepoint
Before intervention, immediately after intervention, one month after intervention
Method of measurement
Personal Growth Scale
2
Description
Positive relations with others
Timepoint
Before intervention, immediately after intervention, one month after intervention
Method of measurement
Positive Relations with Others Scale
3
Description
Self-autonomy
Timepoint
Before intervention, immediately after intervention, one month after intervention
Method of measurement
Self-autonomy Scale
4
Description
Life satisfaction
Timepoint
Before intervention, immediately after intervention, one month after intervention
Method of measurement
Life Satisfaction Scale
5
Description
Spirituality
Timepoint
Before intervention, immediately after intervention, one month after intervention
Method of measurement
Spirituality Scale
6
Description
Happiness and Optimism
Timepoint
Before intervention, immediately after intervention, one month after intervention
Method of measurement
Happiness and Optimism Scale
Intervention groups
1
Description
The intervention group is offered eight structured ninety-minute sessions of problem-solving therapy.
Category
Behavior
2
Description
The control group is offered only routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Shafa Hospital
Full name of responsible person
Elham Taeidi
Street address
Golestan Boulevard
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science
Full name of responsible person
Dr Behzad Sharief Makhmal
Street address
Ground Floor, Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Elham Taeidi
Position
MS in Counseling in midwifery
Other areas of specialty/work
Street address
Ahvaz
City
Ahvaz
Postal code
Phone
+98 989035641795
Fax
Email
elanata12@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Simin Montazeri
Position
PhD in Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 986133367543
Fax
Email
mrssiminmontazeri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Elham Taeidi
Position
MS in Counseling in midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery faculyt, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 989035641795
Fax
Email
elanata12@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)