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Effect of Peer support, Remote, on subjective well-being in patients with colorectal cancer

Protocol summary

Study aim
Determining the effect of Peer support, Remote, on subjective well-being in patients with colorectal cancer
Design
A randomized clinical trial, with control and intervention groups, with parallel design, superiority, randomly divided to two groups of intervention and control (using a random number table using www.randomization.com). Sample size will be determined by Pilot study.
Settings and conduct
After referral to Mashhad's Oncology units, will be completed at the same meeting, pre-test (subjective well-being questionnaire) by Qualified available patients. At the same meeting, patients with peer criterias, as peer, will be selected. Then at the same meeting, the work process is explained to the peers, and the other patients are placed in randomized assignment in two groups of intervention and control. Patients undergoing intervention, After the introduction of the phone, with peer, will be supported by peer for one month, at least twice a week by telephone, and three times a week by the Internet. One month after the end of the intervention, the post-test is performed for two groups. This study will be single blind, analyst will be unaware of the groups of intervention and control and the data collected and which data will be relevant to which group.
Participants/Inclusion and exclusion criteria
People who have colorectal cancer can enter the study. People who do not have colorectal cancer can not enter the study.
Intervention groups
Both groups will be the same for everyone, and the routine self-care checklist is routinely given to both groups. Only the intervention group, under peer support intervention, is placed at least twice a week by phone and at least three times a week by the Internet (virtual network), for one month. There is no intervention in the control group.
Main outcome variables
Increasing subjective well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190123042480N1
Registration date: 2019-03-28, 1398/01/08
Registration timing: registered_while_recruiting

Last update: 2019-03-28, 1398/01/08
Update count: 0
Registration date
2019-03-28, 1398/01/08
Registrant information
Name
Mahla Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3762 9367
Email address
rahimim941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Peer support, Remote, on subjective well-being in patients with colorectal cancer
Public title
Effect of Peer support, Remote, on subjective well-being in patients with colorectal cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People over the age of 18, who have colorectal cancer based on cytological diagnostic findings and an oncologist's confirmation. does not have severe cognitive impairment (his Psychological examination score is greater than 22 of 30). Have literacy reading and writing. Have audiovisual health (ability to hear and see even with auxiliary equipment). Give the phone number to calling. Have the ability to use smartphone and internet (virtual network). Have the ability to communicate verbally and non verbally. The peer also must, in addition to the research unit criteria, have a score of at least 40, from the Warwick-Edinburgh Subjective Welfare Questionnaire, and successfully completed the treatment.
Exclusion criteria:
Patients with colorectal cancer, which have fistulas.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to two groups of intervention and control (using the random numbers table at www.randomization.com).
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups and the data collected and which group it relates to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology University, Mashhad University of Medical Sciences, Opposite University Street 18, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944 - 91388
Approval date
2019-02-09, 1397/11/20
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.076

Health conditions studied

1

Description of health condition studied
Colorectal cancer
ICD-10 code
C18-20
ICD-10 code description
C18 Malignant neoplasm of colon. C19 Malignant neoplasm of rectosigmoid junction. C20 Malignant neoplasm of rectum

Primary outcomes

1

Description
Subjective well-being Score, in the Warwick Edinburgh Questionnaire
Timepoint
Before the intervention and one month after the end of the intervention
Method of measurement
Warwick Edinburgh subjective well-being Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group is subjected to peer support interventions for one month, at least twice a week by phone, and at least weekly by the Internet (virtual network) at least once a week.
Category
Other

2

Description
The control group receives the same routine care and there is no intervention in it.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Mahla Rahimim
Street address
Alandasht Square , Koohsangi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Email
omidhos@mums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahla Rahimi
Street address
Imam Reza Hospital, Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir

3

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mahla Rahimi
Street address
Beginning at Ahmadabad Street, Dr. Ali Shariati Square,
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir

4

Recruitment center
Name of recruitment center
Hashemi Nejad Hospital
Full name of responsible person
Mahla Rahimi
Street address
end of the Abu Rayhan Blvd, Shahid Mofatheh
City
Mashhad
Province
Razavi Khorasan
Postal code
99191 - 91778
Phone
+98 51 3273 7011
Email
p.relations@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taphaghodi
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri 94), Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
99191 - 91778
Phone
+98 51 3879 5031
Email
p.relations@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahla Rahimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 9, Majidi Ave 5., Janbaz Ave 9., Janbaz Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
46339 - 91976
Phone
+98 51 3762 9367
Fax
Email
rahimim941@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahla Rahimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 9, Majidi 5, Janbaz 9, Janbaz Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
46339 - 91976
Phone
+98 51 3762 9367
Email
rahimim941@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahla Rahimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 9, Majidi 5, Janbaz 9, Janbaz Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
46339 - 91976
Phone
+98 51 3762 9367
Email
rahimim941@mums.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
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
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