Protocol summary

Study aim
Determining the effect of group intervention with the patient's main caregiver compared to self-asserting groups on quality of life and sense of coherence in women with breast cancer
Design
A community-based & pragmatic, double blind, randomized clinical trial with a control group
Settings and conduct
A study was conducted on 80 women with breast cancer stage 3&4 at Entekhab Center affiliated to Isfahan University of Medical Sciences. Patients were selected by simple non-random sampling and were randomly assigned to one of the two intervention and control groups. Randomization was done using random numbers table. The staff responsible for collecting questionnaires and analyzing the data did not know the educational package content and the method of assignment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with Breast Cancer Stage 3 and 4; Obtain informed consent; Have reading and writing skills; Being at the age of 18 - 60 years old Non-Inclusion criteria: Presence of psychiatric disorders such as psychosis and personality disorders by taking history; Having another physical illness that prevents the person from participating in the research program Participate in spiritual therapy sessions or therapies.
Intervention groups
Patients in the intervention group participated in family-based group intervention sessions organized by the psychotherapist 2 months after chemotherapy in 10 sessions of 90 minutes with their spouse or primary caregiver. Before and after the 10-session intervention, quality of life questionnaires or QOL-BR 23 and sense of autonomic integrity were filled in by patients with breast cancer. In the control group, the mentioned intervention was performed only for the patient (not for his/her caregiver).
Main outcome variables
Sense of coherence; quality of life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171105037237N2
Registration date: 2018-12-21, 1397/09/30
Registration timing: retrospective

Last update: 2018-12-21, 1397/09/30
Update count: 0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 4827
Email address
p.shirani@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-06-20, 1397/03/30
Trial completion date
2018-06-20, 1397/03/30
Scientific title
Comparison of the effectiveness of family based group therapy and self help group therapy on quality of life and sense of coherence in women with breast cancer after chemotherapy
Public title
The effect of group intervention based on the family (spouse or patient's primary caregiver) on quality of life and sense of coherence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with Breast Cancer Stage 3 and 4 Obtain informed consent Have reading and writing skills Patients at the age of 18-60 years old
Exclusion criteria:
Having diagnostic criteria for psychiatric disorders such as psychosis and personality disorders by taking a history Having another physical illness that prevents a person from participating in the research program Participate in spiritual therapy sessions or therapies
Age
From 18 years old to 60 years old
Gender
Female
Phase
1-2
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
80 patients after chemotherapy and after obtaining informed consent were selected non randomly and easily among patients referring to the Isfahan Entekhab treatment center, and then randomly assigned to intervention and control groups using the random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person responsible for collecting the questionnaires was not informed about which person was in the intervention group and who was in the control group, as well as the data was analyzed by the data analyst after the anonymity. The analyst did not know how the patients were allocated to the groups and the groups were name with an abbreviation name.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences & Health Services,Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.MUI.REC.1396.3.030

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
Quality of life
Timepoint
At three periods including before the intervention, immediately after the end of the 10th training session and 3 months after the end of the intervention (after the tenth session)
Method of measurement
EORTC-QLO-BR 23 Quality of Life Questionnaire

2

Description
Sense of coherence
Timepoint
At three periods including before the intervention, immediately after the end of the 10th training session and 3 months after the end of the intervention (after the tenth session)
Method of measurement
Antonovsky Sense of Sensitivity Questionnaire (SOC-13)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: family based group therapy.Patients in the intervention group participated in family-based group intervention sessions organized by the psychotherapist 2 months after chemotherapy in 10 90-minute sessions with their spouse or primary caregiver. Before and after the 10-session intervention, quality of life questionnaires or QOL-BR 23 and sense of autonomic integrity were filled in by patients with breast cancer.
Category
Treatment - Other

2

Description
Control group: Self help group therapy in which patients participated in the family-based group intervention sessions administered by the psychotherapist 2 months after chemotherapy in 10 sessions of 90 minutes without their primary caregiver. Before and after the 10-session intervention, quality of life questionnaires or QOL-BR 23 and sense of autonomic integrity were filled in by patients with breast cancer.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Entekhab center
Full name of responsible person
Farzad Goli
Street address
Shahid Motahari Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0046
Fax
+98 31 3668 0046
Email
f.goli@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farzad Goli
Street address
Vice chancellor for Research, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0046
Fax
+98 31 3668 0046
Email
f.goli@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Parinaz Shirani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Public Health/Community Medicine
Street address
No.40 , 17 alley, Freiburg street
City
Isfahan
Province
Isfehan
Postal code
8168754944
Phone
+98 31 3668 4827
Email
Parinazshirani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parinaz Shirani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Public Health/Community Medicine
Street address
No.40, 17 alley, Freiburg street
City
Isfahan
Province
Isfehan
Postal code
8168754944
Phone
+98 31 3668 4827
Email
Parinazshirani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parinaz Shirani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Public Health/Community Medicine
Street address
No.40, 17 alley, Freiburg street
City
Isfahan
Province
Isfehan
Postal code
8168754944
Phone
+98 31 3668 4827
Email
Parinazshirani@yahoo.com

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
Information will be available after obtaining permission from the research deputy of the Isfahan University of Medical Sciences, two years after the publication of the article.
When the data will become available and for how long
Information will be available after obtaining permission from the research deputy of the Isfahan University of Medical Sciences, two years after the publication of the article.
To whom data/document is available
Cancer researchers, counselors, psychologists and physicians, and especially community health researchers
Under which criteria data/document could be used
In order to compare the present studies with other similar studies or perform other statistical calculations, after coordination and permission from the vice chancellor of research of the Faculty of Medicine, Isfahan University of Medical Sciences, as well as sending a request to the email Parinazshirani@yahoo.com, information after the inescapable Identification is available to other researchers.
From where data/document is obtainable
Send your email to Parinazshirani@yahoo.com with a clear and concise statement after coordinating and obtaining permission from the research deputy of the Faculty of Medicine, Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Send your email to Parinazshirani@yahoo.com with a clear and concise statement after coordinating and obtaining permission from the research deputy of the Faculty of Medicine, Isfahan University of Medical Sciences.
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