Determination of the effect of peer based education on self care based on management of side effects of chemotherapy in patients with cancer
Design
A final sample of 80 patients with cancer was selected by available method and randomly in two intervention and control group.
Settings and conduct
Empirical study is done at Imam Khomeini Hospital and Omid Urmia Hospital.Cancer patients who undergo chemotherapy for the first time and who do not have previous cancer or chemotherapy based on medical records will be randomly assigned to two intervention and control groups. Then the intervention group will attend two meetings in the peer education program. To determine self-care based on the management of complications of chemotherapy, self-care diaries questionnaire (to measure the number and effect of self-care behaviors) will be used and the data will be analyzed after collection.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1. Persons aged 65-18
2. Having a type of cancer that requires chemotherapy for the first time (based on documentation of the case and and diagnosis of oncology specialist)
3. Ability to communicate with others.
4. willingness and informed consent to participate in the study.
5. Be alert to time and place and person.
6. Have at least the ability to read and write
7. Not having acute mental illness (based on documentation of the case and psychiatrist's opinion)
Exclusion criteria:
1) Recent company in similar educational and research sessions
2) Lack of cooperation for participation in research
3) There is a family relationship or familiarity between people
Intervention groups
the peer intervention group is trained on how to manage the side effects of chemotherapy.
Main outcome variables
self-care based on management of chemotherapy side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161116030926N2
Registration date:2018-11-07, 1397/08/16
Registration timing:registered_while_recruiting
Last update:2018-11-07, 1397/08/16
Update count:0
Registration date
2018-11-07, 1397/08/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4961
Email address
alilu@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer based education on self-care based on management of side effects of chemotherapy in patients with cancer
Public title
The effect of education on management of side effects of chemotherapy in patients with cancer: Clinical trials
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Persons aged 65-18
Having a type of cancer that requires chemotherapy for the first time (based on documentation of the case and and diagnosis of oncology specialist)
Ability to communicate with others
willingness and informed consent to participate in the study
Be alert to time and place and person
Have at least the ability to read and write (to study the pamphlet and fill in the self-care diary questionnaire)
Not having acute mental illness (based on documentation of the case and psychiatrist's opinion)
Exclusion criteria:
Recent attendance at similar educational and research sessions
not cooperate to participate in the research
There is a family relationship or familiarity between people (if only one person is included in the study)
Age
From 18 years old to 65 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
Block Randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia university of Medical Science
Street address
Resalat Street, Mission of Emergency Alley, university of medical science, Urmia Town
City
urmia
Province
West Azarbaijan
Postal code
588185676
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.UMSU.REC.1397.118
Health conditions studied
1
Description of health condition studied
Cancer patients who first came to chemotherapy
ICD-10 code
48.97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
self-care based on management of chemotherapy side effects
Timepoint
One month after the start of chemotherapy
Method of measurement
Self care diary questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Received training by peers
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital and Omid Urumieh Hospital
Full name of responsible person
لیلا حیدرزاده
Street address
Ershad Street-Ayatollah Madras Avenue- urmia-West Azarbaijan
City
urmia
Province
West Azarbaijan
Postal code
588185686
Phone
+98 44 3523 1328
Fax
+98 44 3346 9939
Email
alilu@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
ایرج محبی
Street address
Emergency Alley - Resalat Street
City
urmia
Province
West Azarbaijan
Postal code
588185676
Phone
+98 44 3523 1328
Email
alilu@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
لیلا حیدرزاده
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
faculty of nursing and midwifery Nazlo,11 th sero Road
City
urmia
Province
West Azarbaijan
Postal code
588185676
Phone
+98 44 3523 1328
Email
alilu@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
leyla alilu
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
faculty of nursing and midwifery Nazlo,11 th sero Road
City
urmia
Province
West Azarbaijan
Postal code
588185676
Phone
+98 44 3523 1328
Email
alilu@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Leila Heydarzadeh
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
faculty of nursing and midwifery Nazlo,11 th sero Road
City
urmia
Province
West Azarbaijan
Postal code
588185676
Phone
+98 44 3523 1328
Email
alilu@umsu.ac.ir
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