Investigating the effects supportive care delivery on mood states, general health and competence of caregivers of cancer patients undergoing chemotherapy
Determining the impact of supportive care on general health, competence and mood states of caregivers of cancer patients undergoing chemotherapy
Design
Clinical trail, double blinding, sample size 60. Simple random table with Random Number Generator software will be placed into two control or intervention groups.
Settings and conduct
The study will be conducted in the chemistry department of Peymaniye Jahrom Hospital. The study will include 3 stages before the intervention (4 questionnaires will be filled), intervention (8 individual and group sessions) and after the intervention (4 mentioned questionnaires will be filled immediately and 1 month later). is double blind The researcher collecting data in the last stage and the statistical consultant were blinded.
Participants/Inclusion and exclusion criteria
Age: older than18 years old; be the main caregiver; not being health personnel; not taking care of another chronic patient; having the physical ability and mental to participate in the study.
Intervention groups
Control group: usual care of the chemotherapy department (nurse and doctor visits and chemotherapy)
Intervention group: supportive care will be provided for 8 weeks.
Main outcome variables
Improving the physical condition of patients, meeting the needs of caregivers, developing the role of nurses
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230128057252N1
Registration date:2023-07-08, 1402/04/17
Registration timing:registered_while_recruiting
Last update:2023-07-08, 1402/04/17
Update count:0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
foroogh miri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5444 8187
Email address
foroogh.2001f@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects supportive care delivery on mood states, general health and competence of caregivers of cancer patients undergoing chemotherapy
Public title
The effects nurse supportive care delivery on mood states, general health and competence of caregivers of patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age: older than18 years old
The main caregiver of a patient undergoing chemotherapy
No health personnel
Not taking care of another chronic patient at the same time
Having the ability Physical and mental to participate in the study
Exclusion criteria:
Significant emotional distress
Reluctance to continue cooperation,
Discontinuation of cooperation in patient care
Death of the patient
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
The sample was the main caregivers of cancer patients who met the inclusion criteria
Randomization (investigator's opinion)
Randomized
Randomization description
First, a call will be made in the chemotherapy department. After that, 60 people will be selected from among the volunteers who meet the Word criteria using the Random Number Generator software, and then random allocation will be done into two groups with the help of the previous software from among the 60 selected people.
Blinding (investigator's opinion)
Double blinded
Blinding description
The filling of the questionnaires will be done by the research assistant and the data analysor will be done by the statistical expert blindly
Nurses provider routine care and person who will collect data in the study selection will also be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences. Mtahari St.
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2023-01-29, 1401/11/09
Ethics committee reference number
IR.JUMS.REC.1401.120
Health conditions studied
1
Description of health condition studied
CAREGIVERS OF CANCER PATIENTS
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mood state
Timepoint
Before starting the study - immediately after the intervention - 1 month after the intervention
Method of measurement
PROFILE OF MOOD STATES (POMS)
2
Description
General health
Timepoint
Before starting the study - immediately after the intervention - 1 month after the intervention
Method of measurement
General health questionnaire
Secondary outcomes
1
Description
Caregiver competency
Timepoint
Before starting the study - immediately after the intervention - 1 month after the intervention
Method of measurement
Caregiver competence Scale
Intervention groups
1
Description
For the intervention group: supportive care will be provided for 8 weeks. Intervention steps: 1- Checking the initial evaluation results with questionnaires in the intervention group. 2- Holding training and counseling sessions in small groups (5-7 people) based on the common needs of caregivers, at least 8 sessions for each group (1 session per week). The location of the meetings was inside the chemotherapy department or one of the conference rooms of the hospital. Educational content includes: disease symptom management, stress management, fatigue management, pain control, nutrition maintenance, home care, psychological distress management. 3-Individual training based on the special needs of people if the caregiver declares. 4-Providing a booklet prepared according to the unique needs of caregivers among cancer patients according to scientific sources. Weekly telephone follow-up regarding the provided training and new needs and performing the recommended care. At least 2 times per week 6- Forming a virtual group with the aim of greater interaction and providing educational videos and CDs based on the unique needs of caregivers.
Category
Behavior
2
Description
Control group: For the control group: the usual treatments of the chemotherapy department (chemotherapy - doctor's visit if necessary and nurse's visit) were performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pymanie hospital
Full name of responsible person
Najme Safajo
Street address
Pymanie hospital, Jahad Squ.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5414 2221
Email
hpeymanie@gmail.com
Web page address
https://peymanie.jums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavoss Solhjo
Street address
Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
k.solhjo@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Hojat
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Second floor, Nursinh faculty, Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
0098 71543405
Email
mohsenhojat.mh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
mohsen hojat
Position
Asisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Second floor, Nursinh faculty, Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
0098 71543405
Email
mohsenhojat.mh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Hojat
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Second floor, Nursinh faculty, Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
0098 71543405
Email
mohsenhojat.mh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
All data can be shared after de-identifying samples
When the data will become available and for how long
Access 6 months after results are printed
To whom data/document is available
Only for researchers working in academic and scientific institutions