Objective: Determining the effect of Family-Oriented training on level of depression between patients with Stomach Cancer. The studied group include the patients with Stomach Cancer. The sample size is 40 patients in every group. The samples were selected with using random sampling method and divided into control and test groups randomly. The training course includes five , thirty minutes session in several successive days. The phone follow up continues until the post-test implementation two months after the intervention. The inclusion criterion for this study is: The patients with Stomach Cancer؛ The exclusion criterion is : The absence of the patient and his family from one of the training sessions. The training curriculum includes five successive sessions with the patient and one of his family members in the test group and the patient himself alone in the control group. To compare the test and control groups after two months, then with using post-test the effect of training courses on depression level of the patients will be investigated . The primary outcome is the patient’s level of depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020716513N1
Registration date:2014-12-15, 1393/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-15, 1393/09/24
Registrant information
Name
Yaqob Mahmodi
Name of organization / entity
Tehran University Medical Sceince, Faculty of Nursing
Country
Iran (Islamic Republic of)
Phone
+98 918 381 6700
Email address
y-mahmodi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Expected recruitment start date
2014-07-11, 1393/04/20
Expected recruitment end date
2014-08-11, 1393/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family-based education on level of depression in Stomach cancer patients
Public title
Effect of family-based education on level of depression in Stomach Cancer patients
Purpose
Other
Inclusion/Exclusion criteria
The inclusion criteria:The doctor and the diagnostic tests’ results should confirm the disease diagnosis؛ The patient or one of his family members should be educated؛ They should understand Persian language؛ The patient or his family members should not have received any formal education؛ The minimum age of the patient should be 18 years old. The exclusion criteria:The patient and his family do not want to cooperate anymore؛ The patient and his family do not attend one of the training sessions؛ The patient and his family have attended other organizations’ formal training.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tehran University Of Medical Science
Street address
Tums Center, Ghods st, Keshavarz blv, Tehran
City
Tehran
Postal code
146164745
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
9011196049-1
Health conditions studied
1
Description of health condition studied
stomach cancer
ICD-10 code
(C16)
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
level of depression
Timepoint
Before and two months after intervention
Method of measurement
depression Beck questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the control group, the training course includes five successive sessions with the patient. The formulated content would be taught in five and thirty minutes sessions in several successive days and at the beginning of the first session pretest and at the end the post test would be taken from the topics of interest to confirm the effect of the presented training. The training content includes explaining the disease and its implications and the importance of being informed(first session),acceptance and cure(secondary session),importance of observance and correct use drug(third session),psvchological complication and depresion and the ways of opposition fourth and fifth). Afterwards, phone follow up would continue every two weeks.
Category
Other
2
Description
The training course consists of five successive sessions with the patient and one of his family members in the test group . The formulated content would be taught in five ، thirty minutes sessions in several successive days and at the beginning of the first session pretest and at the end the posttest would be taken from the topics of interest to confirm the effect of the presented training. The training content includes explaining the disease and its implications and the importance of being informed(first session),acceptance and cure(secondary session),importance of observance and correct use drug(third session),psvchological complication and depresion and the ways of opposition fourth and fifth). Afterwards, phone follow up would continue every two weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Daryadokht Masror Rudsary
Street address
Nosrat St, Tohid Sq, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Sixth Floor, Central Organization of TUMS, Keshavarz Blvd, Tehran, Iran
City
Tehran
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, Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Daryadokht Masror Rodsari
Position
Faculty member of Nursing and Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Sq، Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6693 3600
Fax
..............
Email
Daryadokht_masror@yahoo.com
Web page address
.............
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Yaghob Mahmodi
Position
Master of Science
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Sq، Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 8272 3192
Fax
Email
y-mahmodi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Daryadokht Masror Rodsari
Position
Faculty member of Nursing and Midwifery of TUMS
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Sq, Tehran, Iran
City
Tehran
Postal code
...............
Phone
.............
Fax
..........
Email
..........
Web page address
...............
Sharing plan
Deidentified Individual Participant Data Set (IPD)