1. Home
  2. Approved trials
  3. » فارسی

The effect of midwifery- led supportive program on coping strategies and stress in breast cancer women

Protocol summary

Study aim
determining the effect of midwifery- led supportive program on coping strategies and stress in breast cancer women
Design
this study is a controlled clinical trial and one blind experiment whose community includes women with breast cancer referring to chemotherapy sections in Imam Khomeini hospital and Baghban Specialized Clinic in the Sari city.60 patients are chosen by software and Permuted block randomization (ten sextet blocks) in two groups, that 30patients are in intervention group (3 groups of 8-12 patients as entering in to the study) and 30 patients in control groups.
Settings and conduct
Sampling is done in Imam Khomeini hospital and Baghban Specialized Clinic in the Sari city. In intervention group, the supportive program is administered in 6 sessions as one 90-minute session every week.The control group, in addition to routine care, will receive an individual training session after completing the latest post-test questionnaire.
Participants/Inclusion and exclusion criteria
inclusions: stage I to III, at most one year after diagnosis, patients under at least one session chemotherapy, at least finishing primary school; exclusions: suffering from another cancer, participating in others psychotherapy interventions, suffering from severe psychiatric disorders (panic attacks, severe depression and anxiety and...), participating in consulting courses for last 6 months
Intervention groups
intervention group: the supportive program is administered in 6 sessions as one 90-minute session every week. In sessions, they are informed about breast cancer, coping strategies, reducing stress. control group: in addition to routine care, will receive an individual training session after completing the latest post-test questionnaire.
Main outcome variables
coping strategies and stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150608022609N4
Registration date: 2018-11-20, 1397/08/29
Registration timing: registered_while_recruiting

Last update: 2018-11-20, 1397/08/29
Update count: 0
Registration date
2018-11-20, 1397/08/29
Registrant information
Name
Zohre Shahhosseini
Name of organization / entity
Mazandaran Univercity of Medical Science, Nasibe School Of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.shahhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-16, 1397/08/25
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of midwifery- led supportive program on coping strategies and stress in breast cancer women
Public title
the effect of midwifery-led supportive program on coping strategies and stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
stage I to III at most one year after diagnosis patients under at least one session chemotherapy at least finishing primary school
Exclusion criteria:
suffering from another cancer participating in others psychotherapy interventions suffering from severe psychiatric disorders (panic attacks, severe depression and anxiety and...) participating in consulting courses for last 6 months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
60 patients are chosen by software and Permuted block randomization (ten sextet blocks) in two groups, that 30patients are in intervention group (3 groups of 12-8 patients as entering in to the study) and 30 patients in control groups.
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 Mazandaran University of Medical Science
Street address
Deputy of Research and Technology of Mazandaran University of medical Sciences,Moalem Square, Moalem Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2018-09-26, 1397/07/04
Ethics committee reference number
IR.MAZUMS.REC.1397.155

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
coping strategies
Timepoint
Pre- intervention, Immediately and one month after intervention
Method of measurement
Coping Strategies Questionnaire (Folkman and Lazarus)

Secondary outcomes

1

Description
ُStress
Timepoint
Pre- intervention, Immediately and one month after intervention
Method of measurement
Depression, Anxiety and Stress questionnaire (DASS-21)

Intervention groups

1

Description
Intervention group:In intervention group, the supportive program is administered in 6 sessions as one 90-minute session every week. In sessions, they are informed about breast cancer, coping strategies, reducing stress.
Category
Behavior

2

Description
Control group:The control group, in addition to routine care, will receive an individual training session after completing the latest post-test questionnaire.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Misagh Shafizad
Street address
Imam Khomeini Hospital، Amir Mazandarani Avenue، Sari، Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
Emamsarih@gmail.com

2

Recruitment center
Name of recruitment center
Baghban Specialized Clinic
Full name of responsible person
Mohammad Panbehchi
Street address
Baghban Specialized Clinic، Former Medical Faculty، Khazar Boulevard، Sari، Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816895474
Phone
+98 11 3324 0002
Email
mhpanbehchi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
َAkbar Hedayatizadeh Omran
Street address
Deputy of Research and Technology of Mazandaran University of medical Sciences,Moalem Square, Moalem Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Email
akbar_hedayati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Elahe samami
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
City
ُSari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
elahesamami70@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Shahhosseini
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
zshahhosseini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Elahe samami
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
elahesamami70@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...