The aim of the study is to investigate the effect of nurse telephone support on self-care and supportive care needs of patients undergoing chemotherapy.
Design
This study will be conducted on 60 patients with cancer at Ayatollah khansary Hospital in Arak. The aim of the study is to investigate the effect of nurse telephone support on self-care and supportive care needs of patients undergoing chemotherapy. Patients will be recruited in the study by convenience sampling and will be assigned randomly to an intervention group who will receive telephone call twice-a-week for one month and control group who will receive routine care. The supportive care needs questionnaire (SCNS-34) and Leuven Questionnaire for Self-Care during Chemotherapy (L-PaSC) will be completed before intervention (the second round of chemotherapy), one month after the intervention (the third round of chemotherapy), and the fourth round of chemotherapy. Data will be analyzed using SPSS software.
Settings and conduct
Ayatollah-Khansari Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People diagnosed with cancer more than one month, and undergoing chemotherapy; Aged between 18-80 years; Awareness of their diagnosis; Physically and mentally ability to participate in the study, Patients with non-metastatic cancer, Access to a mobile phone or telephone
Exclusion criteria:
Lack of interest in participating in every stage of the study, Death;
Intervention groups
Intervention group: Patients will be contacted twice a week, at certain times of day
In the control group: Will be received routine care.
Main outcome variables
Care Needs Survey
Self-Care during Chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170404033216N1
Registration date:2018-01-26, 1396/11/06
Registration timing:registered_while_recruiting
Last update:2018-01-26, 1396/11/06
Update count:0
Registration date
2018-01-26, 1396/11/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.ebrahimabadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-16, 1396/09/25
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of telephone-based support intervention on self-care and supportive care needs of patients undergoing chemotherapy
Public title
The impact of telephone-based support intervention on self-care and supportive care needs of patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People diagnosed with cancer more than one month and undergoing chemotherapy
Aged between 18-80 years
Awareness of their diagnosis; Physically and mentally abbility to participate in the study
Patients with non-metastatic cancer
Access to a mobile phone or telephone
Exclusion criteria:
Lack of interest in participating in every stage of the study
Death
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization, a computer-generated randomization will be used to create an allocation sequence with a block size of four to assign patients to the two study arms. It begins this process by giving each patient an identification number.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the study neither the participant nor the outcome evaluator are aware of control or intervention groups assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Great Prophet University Complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
38481-7-6941
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.ARAKMU.REC.1396.149
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasm
Primary outcomes
1
Description
Supportive Care Needs Survey
Timepoint
The first step, before the second round of chemotherapy, The second step, the third round of chemotherapy, The third stage, the fourth round of chemotherapy;
Method of measurement
Supportive Care Needs Survey (Short Form)scale
Secondary outcomes
1
Description
Self-Care during Chemotherapy
Timepoint
The first step, before the second round of chemotherapy, The second step, the third round of chemotherapy, The third stage, the fourth round of chemotherapy;
Method of measurement
Leuven Questionnaire for Self-Care during Chemotherapy (L-PaSC) scale
2
Description
Supportive Care Needs Survey during Chemotherapy
Timepoint
The first step, before the second round of chemotherapy, The second step, the third round of chemotherapy, The third stage, the fourth round of chemotherapy;
Method of measurement
Supportive Care Needs Survey (Short Form) scale
Intervention groups
1
Description
Intervention group: Patients will be contacted twice a week, at certain times of the day.
Category
Lifestyle
2
Description
Control group: Will be receive routine care.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah-Khansari Hospital
Full name of responsible person
Dr Arjomandzadegan, Vice Chancellor for research
Street address
Great Prophet University Complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
38481-7-6941
Phone
+98 86 3414 3639
Email
pajoohesh@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Arjomandzadegan, Vice Chancellor for research
Street address
Great Prophet University Complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3414 3639
Email
Research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Maryam Ebrahimabadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Great Prophet University Complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
m.ebrahimabadi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazi Nejat
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Great Prophet University Complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
nejat@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazi Nejat
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Great Prophet University Complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
nejat@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD