The impact of remote human caring on the comfort of breast cancer patients undergoing radiation therapy: a clinical trial based on «Watson» and «Kolkaba» theoretical frameworks
Determining the Impact of Human Remote Care on the Comfort of Breast Cancer Patients Undergoing Radiation Therapy Based on «Watson» and «Kolcaba» Theories
Determining the mean comfort score of breast cancer patients undergoing radiotherapy in comparison and intervention groups, before and after remote human care
Determining the difference between the mean comfort scores of breast cancer patients undergoing radiotherapy in comparison and intervention groups, before and after the implementation of remote human care
Design
Clinical trial with control and intervention group, factorial, without blinding, randomized, one phase on 58 patients. For randomization, 4 random blocks were used using a random number table.
Settings and conduct
Khorramabad Rain Radiotherapy Center, remote human care in the form of at least 7 absentee sessions and two face-to-face sessions
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Definite onset of primary breast cancer
Stages 2 and 3 of the disease
Chemotherapy and surgery before radiation therapy
Stability of the patient's physical and mental
Age between 20 to 60 years
Criteria for not entering:
Lack of patient awareness of breast cancer diagnosis
Exacerbation or spread of the disease to other parts of the body
Primary cancer in other areas
Existence of crises affecting life during the last 6 months or during illness
The patient's unwillingness to continue participating in the study
Change of center and treatment process
Death
Intervention groups
Both groups received comparison and routine care intervention. However, in the intervention group, the effect of remote human care on the comfort of breast cancer patients undergoing radiation therapy was evaluated in the form of at least 7 absentee sessions and two face-to-face sessions of care.
Main outcome variables
comfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210118050076N1
Registration date:2022-01-30, 1400/11/10
Registration timing:retrospective
Last update:2022-01-30, 1400/11/10
Update count:0
Registration date
2022-01-30, 1400/11/10
Registrant information
Name
Zeinab yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3330 3370
Email address
yousefi1598@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-29, 1399/11/10
Expected recruitment end date
2022-01-30, 1400/11/10
Actual recruitment start date
2021-02-03, 1399/11/15
Actual recruitment end date
2021-10-22, 1400/07/30
Trial completion date
2021-10-22, 1400/07/30
Scientific title
The impact of remote human caring on the comfort of breast cancer patients undergoing radiation therapy: a clinical trial based on «Watson» and «Kolkaba» theoretical frameworks
Public title
The impact of remote human caring on the comfort of breast cancer patients undergoing radiation therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definite onset of primary breast cancer by inclusion in a medical record by a specialist
Stages 2 and 3 of the disease
Chemotherapy and surgery before radiation therapy
Candidate for radiation therapy for the first time
Number of radiation therapy sessions in total 28 to 35 sessions
Six million electron volts radiation therapy with a compact six-megavolt device manufactured by the British company "Elekta"
Breast surgery in the form of complete breast removal or breast retention surgery
Stability of the patient's physical, mental and psychological condition, according to the patient and approved by the doctor
Age between 20 to 60 years
Not participating in similar studies or research
Ability to communicate verbally in Persian or a comprehensible local dialect
Exclusion criteria:
Patient's lack of knowledge about breast cancer diagnosis
Exacerbation or spread of the disease to other parts of the body
Primary cancer in other areas
Existence of crises affecting life during the last 6 months or during illness (death of a loved one, divorce, etc.)
The patient's unwillingness to continue participating in the study
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were divided into two groups of intervention and comparison using stratified random blocking method. The samples were matched in two groups based on the "disease stage" (stages 2 and 3) and this variable was considered as a class in random allocation. Within each floor, the method of 4 random blocks was used to assign patients to two groups A (intervention) and group B (comparison). To do this, a list of blocks was first written and the numbers assigned to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)). Then, using a random number table, the numbers between one to 6 were randomly selected and finally the treatment allocation list was formed based on a sequence of letters A and B.
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 Lorestan University of Medical Sciences
human caring, remote care, comfort, breast cancer, radiation therapy, Jean Watson's Theory, Katharine Kolcaba's Theory
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Comfort score in radiotherapy comfort questionnaire or percentage of people whose comfort questionnaire score is above 4
Timepoint
Measure comfort 2 to 3 weeks before the start of radiation therapy and at the end of radiation therapy
Method of measurement
How to measure the comfort variable is the "Radiation Therapy Comfort Questionnaire".
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Human care was performed in the form of ten Watson romantic care processes during 2 face-to-face sessions during radiation therapy and at least 7 absentee sessions from 2 to 3 weeks before the start of radiation therapy until the end of radiation therapy. The duration of the sessions was free and according to the patient's needs.
Category
Treatment - Other
2
Description
Control group: For this group, only routine care was provided by the radiation therapy center. And was not intervened by the researcher during radiation therapy.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baran radiationtherapy center
Full name of responsible person
Zeinab Yousefi
Street address
Baran radiation therapy center, Basij 3 Street, Basij Alley, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6819616164
Phone
+98 66 3335 5303
Email
yousefi1598@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Bahram Rasoolian
Street address
Baran radiotherapy center, Basij 3 Street, Basij Alley, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6819616165
Phone
+98 66 3335 5304
Email
yosefi1598@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the study of participants' personal data is not one of the goals of the study. And only the comfort score of people is measured.
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Only information about the main outcome can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The use of data is permissible only descriptively and with the permission of the principal investigator.
From where data/document is obtainable
Esmatollah Yousefi House, Baharestan 9, Baharestan Blvrd, Khorramabad, Lorestan.
Name of researcher Zeinab Yousefi
yousefi1598@gmail.com First priority
09168586532 Second priority
What processes are involved for a request to access data/document
About a month after receiving the email, their request will be answered.