The effect of group therapy based on coping strategies on mental adjustment of the women with gynecological cancer that referred to urmia education- research and treatment centers
This study was carried out to determine the effect of group therapy based on coping strategies in the mental adjustment of women with Gynaecological cancer referring to Urmia educational centers in 1395-1396.
Design
In this survey, 70 women with gynecologic cancer who are referred to Urmia treatment-educational centers will be selected by simple random sampling method. Samples will be assigned randomly to intervention and control groups and will be assigned a code for each participant.
Settings and conduct
The present study was conducted in Urmia In this way, Individuals were randomly assigned into two groups of 35 subjects intervention and control. The experimental group was divided into three subgroups of 11-12-12 people and during eight sessions of 1.5-2 hours that held weekly in one session was subjected to group therapy interventions based on coping strategies. But for control group no treatment was applied. After the end of the sessions, a three-month deadline was given to the team to carry out coping skills working in the group, in their daily lives. Assessment form of mental adaptation in cancer before the intervention; after intervention; one month after the intervention; and three months after the intervention was completed by patients.
Participants/Inclusion and exclusion criteria
Major inclusion criteria include knowledge of disease; willingness to participate in research; having Literacy reading and writing; passing at least 6 months of illness and Major exclusion criteria include participating in psychiatric intervention at the same time as intervention; having another chronic disease; Incidencing an important stressful factor in life.
Intervention groups
70 eligible women were randomly divided into two groups of 35 controls and intervention.The intervention group was divided into three subgroups of 11-12-12 people and Based on group therapy interventions with coping strategies.
Main outcome variables
The main variable is the outcome of assessment form of mental adaptation in cancer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140212016564N6
Registration date:2018-01-12, 1396/10/22
Registration timing:prospective
Last update:2018-01-12, 1396/10/22
Update count:0
Registration date
2018-01-12, 1396/10/22
Registrant information
Name
Molood Radfar
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1275 4961
Email address
radfar.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences, Vice Chancellor of Research
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-08-20, 1397/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group therapy based on coping strategies on mental adjustment of the women with gynecological cancer that referred to urmia education- research and treatment centers
Public title
The effect of group therapy on mental adjustment of the women with gynecological cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with gynecological cancer
lack of participation in group therapy programs in the last three months
having Literacy reading and writing
ability to communicate
Passed at least six months after the onset of the disease
lack of distant metastases
Awareness of own illness
The desire to participate in the study
Exclusion criteria:
History of using Psychiatric drug
concurrent suffering with another chronic illness
Participation in psychiatric interventions simultaneously with research implementation
The emergence of an important stressful factor in life
A prominent history of mental illness
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
150 women with gynecological cancer who were referred to treatment centers in the years 1395 and 1396 were selected. After reviewing the records of these patients and considering the inclusion and exclusion criteria and other criteria, 100 eligible patients were enrolled in the study. Considering that 70 patients were needed for intervention. A total of 70 individuals were randomly selected (random numbers). The method of assignment to groups was done in this way That: We put 35 A cards and 35 B cards in the envelope and mixed them thoroughly(Card A represents the intervention group and the B card index represents the control group), Then the cards are randomly arranged in a row. Anyone who entered the study was able to take one of the cards and enter the study, respectively. In this way, the intervention group and the control group were identified.
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 Urmia University of Medical Sciences
Street address
Urjance alley, Resalat Blvd, Urmia, Iran
City
urmia
Province
West Azarbaijan
Postal code
5756115111
Approval date
2016-12-09, 1395/09/19
Ethics committee reference number
ir.umsu.rec.1395.380
Health conditions studied
1
Description of health condition studied
Gynecologic cancer
ICD-10 code
C51-C58
ICD-10 code description
Malignant neoplasms of female genital organs
Primary outcomes
1
Description
The effect of intervention (group therapy based on coping strategies) on mental adjustment of participants was assessed using the mental adjustment questionnaire in cancer in four stages before intervention, after intervention, one month after intervention and three months after intervention. And compared to the control group.
Timepoint
Before the intervention immediately after the intervention one month later and three months after the intervention
Method of measurement
Mini-Menta lAadjustment to Cancer scale
Secondary outcomes
empty
Intervention groups
1
Description
To implement the group therapy, the intervention group was divided into three small groups of 11-12-12 people, Each subgroup underwent a group therapy based on coping strategie which was held in eight sessions of 2 hours and one day per week. The group's force was used to create new methods and to have a positive impact on each other and learning from each other. At the end of each meeting, a homework assignment was provided for patients. Which was reviewed and rated at the next meeting at the end of the work, those who received more points were ewarded. The titles of the meetings were as follows: The First meeting included introduction and familiarity of the group members with each other and explaining the principles of the group, the definition of cancer and the causes of cancerous cell and the presentation of an educational booklet prepared by the researcher for study, which included the knowledge that help to alleviate patient anxiety.The second meeting included discussions about the fighting spirit, acceptance of their role, belief in their ability, and negative self-change. Third session included physical care such as: healthy eating, physical activity, changing the style of life, accepting responsibility and seeking social support.The fourth session included a search for treatment, such as: Participation with the treatment team and follow-up therapy. The fifth session included psychological care such as: religious beliefs, valuing your interests, modifying negative beliefs, gaining emotional support, self-control and do not follow the culprit. The sixth session included the use of sedative techniques such as slow and deep breathing, mental imagery, thought leadership, realism, and complementary therapies such as laughter therapy and the use of relaxed speech.The seventh session included anti recurrence strategies, such as providing information on the recurrence of disease, the importance of pursuing health care and maintaining the fighting spirit.The Eighth session Scores recorded from each patient were reviewed and awarded to the highest score. one of the Cancer who were victorious in curing cancer, talked to patients. After the end of the sessions, a three month deadline was given to the team to carry out coping skills working in the group, in their daily lives. Assessment form of mental adaptation in cancer before the intervention; after intervention; one month after the intervention; and three months after the intervention was completed by patients.
Category
Behavior
2
Description
During the intervention, the control group did not receive any coping skills and in terms of data entry was about control.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital-Urmia
Full name of responsible person
Moloud Radfar
Street address
Omid Street, Farhangian Town, Orumieh, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3382 2209
Email
info@omidcharity.org
Web page address
http://www.omidcharity.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohebbie Erag
Street address
Urjance alley, Resalat Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3223 4897
Email
Mohebbi_iraj@yahoo.co.uk
Web page address
http://www.umsu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Smaeilzadeh khangah Sepideh
Position
The Master Science student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3345 4810
Fax
Email
Sepideh29729784@gmail.com
Web page address
http://www.umsu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Radfar Moloud
Position
Nursing PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4964
Fax
Email
Mradfar1343@gmail.com
Web page address
http://www.umsu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Smaeilzadeh khangah Sepideh
Position
The Master Science student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Urmia Faculty of Nursing and Midwifery
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3348 4510
Fax
Email
sepideh297297@gmail.com
Web page address
http://www.umsu.ac.ir/
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
File Title: Mental Adjustment Data
The whole data will be shared after being unidentified.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
The data will be available to other researchers in the form of a printed article.
Other researchers are allowed from the research team to use the data.
From where data/document is obtainable
Radfar moloud
Email:mradfar1343@gmail.com
What processes are involved for a request to access data/document
You will submit your application to Mrs. Radfar, who will send you the requested application within ten days after reviewing your request.