Protocol summary

Study aim
Determination The ٍٍEffect of Telephone Counseling and Education on Caregiver Strain and Unmet Needs in Family Caregivers and Self-care Behaviors of Patients with Cancer
Design
Clinical trials with control group, randomized, with parallel groups, without blinding
Settings and conduct
In two health Education clinics of Ghaem and Omid Hospital in Mashhad, 60 Caregivers and patients (in pairs) are randomly divided into two groups of control and intervention. Before intervention, demographic information and Caregiver Strain questionnaires and Unmet needs are completed by Caregivers and demographic information questionnaires and self-care behaviors are completed by patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria patients: willingness to participate in the study and informed consent, The definitive diagnosis of cancer of the esophagus and stomach and colorectal, Age greater than 18 and less than 65 years, The ability to read and write in Persian, Lack of speech and hearing problems, Candidate of Therapy 3 chemotherapy courses, Having access to the phone, Not a member health team, Lack of support by advocacy group, The main caregiver of being patient, The absence of specific psychological problems in carers and the use of medication to treat it; Unwillingness to continue cooperation
Intervention groups
In the intervention and control group, a 20-minute face-to-face training session is scheduled for caregivers of cancer patients.During this meeting, will be explained on how to care for the patient and At the end of the meeting, will be given several educational pamphlets include the materials taught to caregivers.In addition to face-to-face training and educational pamphlets, the intervention group will receive four telephone consultations within 2 months (three courses of chemotherapy).
Main outcome variables
Caregiver Strain, Unmet Needs, Self-care Behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181114041660N1
Registration date: 2018-11-24, 1397/09/03
Registration timing: prospective

Last update: 2018-11-24, 1397/09/03
Update count: 0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
fatemeh ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3523 8858
Email address
ghorbanif941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The ٍٍEffect of Telephone Counseling and Education on Caregiver Strain and Unmet Needs in Family Caregivers and Self-care Behaviors of Patients with Cancer
Public title
The ٍٍEffect of Telephone Counseling and Education on Caregiver Strain and Unmet Needs in Family Caregivers and Self-care Behaviors of Patients with Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria patients: willingness to participate in the study and informed consent The definitive diagnosis of cancer of the esophagus and stomach and colorectal Age greater than 18 and less than 65 years The ability to read and write in Persian Lack of speech and hearing problems Candidate of Therapy 3 chemotherapy courses Having access to the phone Not a member health team Lack of support by advocacy group Inclusion criteria caregivers: willingness to participate in the study and informed consent The main caregiver of being patient The ability to read and write in Persian Having access to the phone Lack of speech and hearing problems The absence of specific psychological problems and the use of medication to treat it Not a member health team Lack of support by advocacy group
Exclusion criteria:
Unwillingness to continue cooperation Failure to answer telephone calls and disconnect (if He/She does not answer 3 phone calls) The occurrence of stressful events for carers and patients during an intervention such as divorce, death of close relatives, sick death and job loss Failure to fully complete all three questionnaire of the self-care patients by the patients and the Burden and Unmet needs by the caregivers The patient's inappropriate general condition during the intervention so that his continued cooperation is not feasible Caregiver support by support groups
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block،Put the Four blocks in a sealed envelope and Then they will be arranged in a straightforward Lottery way.
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
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Ebne sina St, Mashhad Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-10-16, 1397/07/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.056

Health conditions studied

1

Description of health condition studied
Esophagus Cancer
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of esophagus

2

Description of health condition studied
Stomach Cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach

3

Description of health condition studied
Colon Cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon

4

Description of health condition studied
Colon Cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction

5

Description of health condition studied
Rectum Cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum

6

Description of health condition studied
Rectum Cancer
ICD-10 code
C21
ICD-10 code description
Malignant neoplasm of anus and anal canal

Primary outcomes

1

Description
Caregiver Strain
Timepoint
Before the intervention and at the end of the intervention (the end of the second month)
Method of measurement
Zarit caregiver Burden Inventory

2

Description
unmet needs
Timepoint
Before the intervention and at the end of the intervention (the end of the second month)
Method of measurement
Supportive Care Needs Survey Partners and Caregivers

3

Description
self-care behaviors
Timepoint
Before the intervention and at the end of the intervention (the end of the second month)
Method of measurement
Nail Self- care Dairy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In the intervention group, a 20-minute face-to-face training session will be provided to caregivers of cancer patients.During this meeting, will be briefly explained on how to care for the patient, nutrition, activity and rest, the prevention of infection and the management of the symptoms of the disease and the side effects of chemotherapy and at the end of the meeting several educational pamphlets includes subjects taught will be given to carers.In addition to face-to-face training and educational pamphlets, the intervention group will receive four telephone consultations within 2 months (in the first course of chemotherapy after entering the study 2 calls and in the second and third chemotherapy course each one will receive a call).In the first telephone interview, a review of educational materials about patient problems and self-care with the patient is conducted and the second session will be discussed with the caregiver about symptoms management, Uncertainty reduction , optimistic attitudes and effective adjustment skills.
Category
Other

2

Description
Control group: In the control group, a 20-minute face-to-face training session will be provided to caregivers of cancer patients.During this meeting, will be briefly explained on how to care for the patient, nutrition, activity and rest, the prevention of infection and the management of the symptoms of the disease and the side effects of chemotherapy and at the end of the meeting several educational pamphlets includes subjects taught will be given to carers.Carers will receive routine education through nurses and referral to hospital health Education clinics.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Ghorbani Fatemeh
Street address
Dr. Ali Shariati Square, Beginning at Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
ghorbanif941@mums.ac.ir

2

Recruitment center
Name of recruitment center
Omid haspital
Full name of responsible person
Ghorbani Fatemeh
Street address
koohsangi َAve, Alndasht Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Email
Ghorbanif941@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
University St, Facing University Street 18, Deputy of University Technology and Research
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3841 2081
Email
tafaghodim@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
Ghorbani Fatemeh
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad, Ebme sina St, Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ghorbanif941@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zare Masoud
Position
tutor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad, Ebne sina St, Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
zaremd@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghorbani Fatemeh
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad, Ebne sina St, Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ghorbanif941@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used for other human research and health centers
From where data/document is obtainable
Library of the School of Nursing and Midwifery of Mashhad ghorbanif941@mums.ac.ir
What processes are involved for a request to access data/document
Visit the Library of Nursing and Midwifery Faculty of Mashhad
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