Protocol summary

Summary
This medical research has been done for the analysis of the effects of the educational package on the quality of life of women who suffer from cervical cancer .This research consists of a selected sample of seventy two cervical cancer patients who are selected randomly according to the criteria of Iranian nationality and stages 1,2 & 3 of this disease .This group is randomly divided in to intervention and control group. After the completion of a pretest or preliminary questionnaire, these two groups are separated, then during four sessions and ninety minutes per week, a researcher and a psychologist present the content of the educational package for the intervention group. The main focus of the first session is on the definition of this disease, subtypes, age of infection, risk factors and the quality of life. And, finally all of the patients receive booklets .In the second session, the patients are asked to brainstorm as many solutions as possible for the problems ,anxieties and the negative effects of the disease on their lives. In the third session,which is called group therapy, both patients and their attendants try to deal with the above mentioned problems . In the fourth session, with the presence of a psychologist many questions related to stress management, depression, disappointment and relaxation techniques are answered. In addition to these arrangements, some inspiring and spiritual slide shows are presented .In the end, the patients are invited to come for the further completion of the questionnaire after twelve weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207039463N4
Registration date: 2012-07-15, 1391/04/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-15, 1391/04/25
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences , vice chancellor for research
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of implementation of educationl package on quality of life of cervical cancer women
Public title
The impact of implementation of educationl package on quality of life of cervical cancer women
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: Iranian nationality; cervical cancer affiction in stage 1 , 2 & 3 that diagnosed with biopsy; absence of psychologic or known cognitive disease; absence of another cancers exclusion criteria: refuse from continuance of participation in study; complete faulty of questionnaires
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
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 Sciences
Street address
floor6,central organization of university, qods street, keshavarz blv.
City
Tehran
Postal code
Approval date
2012-04-08, 1391/01/20
Ethics committee reference number
130/2575/د/90

Health conditions studied

1

Description of health condition studied
quality of life ih women with cervical cancer
ICD-10 code
C53.9
ICD-10 code description
malignant neoplasms of female genital organs

Primary outcomes

1

Description
quality of life
Timepoint
before intervention and 12 weeks after intervention
Method of measurement
adjusted questionnaire of quality of life in women with cervical cancer

Secondary outcomes

1

Description
physical domain of quality of life
Timepoint
before intervention and 12 weeks after intervention
Method of measurement
physical domain of adjusted questionnaire of quality of life in women with cervical cancer

2

Description
social - family domain of quality of life
Timepoint
before intervention and 12 weeks after intervention
Method of measurement
social - family domain of adjusted questionnaire of quality of life in women with cervical cancer

3

Description
emotional domain of quality of life
Timepoint
before intervention and 12 weeks after intervention
Method of measurement
emotional domain of adjusted questionnaire of quality of life in women with cervical cancer

4

Description
functional domain of quality of life
Timepoint
before intervention and 12 weeks after intervention
Method of measurement
functional domain of adjusted questionnaire of quality of life in women with cervical cancer

5

Description
sexual domain of quality of life
Timepoint
before interventin and 12 weeks after intervention
Method of measurement
sexual domain of adjusted questionnaire of quality of life in women with cervical cancer

Intervention groups

1

Description
control group : This group are received their routine cares and cures and are not received educational package.
Category
Other

2

Description
The content of educational package will be presented during four , 90 minutes sessions and per week. The first session is on the definition of cervical cancer and concept of quality of life ,its different aspects and impressive factors on it . finally all of the patients will be received booklets .The second session, the patients will disscuss to brainstorm about their problems and anxieties. Third session,in next week , patients and their attendants group therapy will be done, patients will be invided to groups 3-5persons and each group and their attendants try to deal with the above mentioned problems. In this session , educational film will be displayed. The fourth session, with questions related to stress management, depression, disappointment and relaxation techniques are answered. In addition to these arrangements, some inspiring and spiritual , slide shows are presented in 15 minutes.The questionnaires after 12 weeks will be completed in this group, again.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini hospital in Tehran
Full name of responsible person
Razie Chahardehi- Master student of midwifery
Street address
Tohid square , East nusrat str, school of Nursing & midwifery Tehran University of Medical Sciences
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences, vice chancellor for research
Full name of responsible person
Dr Akbar Fotuhi-
Street address
floor 6 , central organization of University , quds street , Keshavarz blv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, vice chancellor for research
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Behboodi Moghaddam
Position
PhD in Reproductive Health/ Manager of Reproductive Health
Other areas of specialty/work
Street address
Tohid Square , East Nusrat street , school of Nursin & Midwifery
City
Tehran
Postal code
Phone
+98 21 6105 4226
Fax
Email
bahar_behboodi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Behboodi Moghaddam
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Tohid square , East Nusrat street , school of Nursing & Midwifery of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6105 4226
Fax
Email
bahar_behboodi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razie Chahardehi
Position
Master student of Midwifery
Other areas of specialty/work
Street address
Tohid square , East Nusrat street , school of Nursing & Midwifery Tehran University of Medical Scuiences
City
Tehran
Postal code
Phone
+98 21 8851 2396
Fax
Email
chahardehi@razi.tums.ac.ir razie1380@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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