Protocol summary

Summary
The present study will be done to determine how effective “life review treatment with spiritual approach” is to improve the quality of life in cancer patients hospitalized in Shahid Beheshti Hospital of Kashan. Among all cancer patients hospitalized in Shahid Beheshti Hospital of Kashan who are 20-75 years old, undergoing chemotherapy, and not being in severe conditions or other physical and mental disorders which interferes with taking part in the study, a random sample of 80 patients will be allocated into two groups "experiment and control". These two groups will be matched in sex, age and duration of illness. This study is interventional with pretest and posttest design with control group. At first, quality of life will be measured for the two groups by using EORTC QLQ-C30 questionnaire. Then six episodes of individual counseling of life review treatment with spiritual approach will be done for experiment group in six weeks, once a week, and one hour. In this period, no interventions will be done for control group. At last, quality of life will be measured again by using EORTC QLQ-C30 questionnaire. Then gathered data will be analyzed using descriptive and deductive statistical tests in SPSS statistical software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108297440N1
Registration date: 2012-05-24, 1391/03/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-24, 1391/03/04
Registrant information
Name
Narges Sayyadi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 263 3805
Email address
sayyadi_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2011-04-05, 1390/01/16
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of life review with spirituality approach in quality of life in cancer patients
Public title
Life review with spirituality approach in quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 20-75 years old cancer patients, undergoing chemotherapy; passing 2 weeks from diagnosis; being able to answer the questions; not being in severe conditions or other physical and mental disorders. Exclusion criteria: receiving other treatments; not willing to take part in the study, getting other physical and mental disorders.
Age
From 20 years old to 75 years old
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences and Health Services
Street address
Kashan University of Medical Sciences and Health Services, Ravand Blvd
City
Kashan
Postal code
8715988141
Approval date
2011-03-01, 1389/12/10
Ethics committee reference number
3533/1/5/29/پ

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, unspecified

Primary outcomes

1

Description
quality of life
Timepoint
before and after the intervention
Method of measurement
EORTC QLQ-C30

Secondary outcomes

empty

Intervention groups

1

Description
life review with spiritual in intervention group
Category
Behavior

2

Description
There is no intervention in control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Gholamali Hamidi
Street address
Kashan University of Medical Sciences and Health Services, Ravand Blvd
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences and Health Services
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
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Mohsen Taghadosi
Position
Scientific staff
Other areas of specialty/work
Street address
Kashan University of Medical Sciences and Health Services, Ravand Bolvaard, kashan.
City
kashan
Postal code
8715988141
Phone
+98 36 1557 5058
Fax
+98 36 1557 5058
Email
Amfahimifar@yahoo.com, Taghadosi_1345@yahoo.com, Taghadosi_m@kaums.ac.ir
Web page address
http://feyz.kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan university of medical sciences and health services
Full name of responsible person
Mohsen Taghadosi
Position
PhD student in Nursing
Other areas of specialty/work
Street address
Kashan university of medical sciences and health services, Ravand Bolvard, kashan,
City
Kashan
Postal code
8715988141
Phone
+98 36 1557 5058
Fax
+98 36 1557 5058
Email
Amfahimifar@yahoo.com, Taghadosi_1345@yahoo.com, Taghadosi_m@kaums.ac.ir
Web page address
http://feyz.kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Ameneh Fahimifar
Position
Msc in family counseling
Other areas of specialty/work
Street address
Kashan University of Medical Sciences and Health Services, Ravand Blvd
City
Kashan
Postal code
8715988141
Phone
+98 36 1557 5058
Fax
+98 36 1557 5058
Email
Amfahimifar@yahoo.com, Taghadosi_1345@yahoo.com, Taghadosi_m@kaums.ac.ir
Web page address
http://feyz.kaums.ac.ir

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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