A comparative study of the effect of the family-centered empowerment model based on mucositis management on the quality of life of parents and children with cancer undergoing chemotherapy
Comparison of the average quality of life scores of parents and children with cancer undergoing chemotherapy in two control and intervention groups (using family-centered empowerment according to Al-Hani model)
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 60 patients. The random allocation sequence was determined using Random Allocation Software.
Settings and conduct
A semi-experimental study was conducted on 60 parents of children with cancer undergoing chemotherapy who referred to Shahrekord Kashani Hospital in 2019-2020. The sampling method was available and then they were divided into two intervention and control groups by random allocation method. The data analyst was blinded to the allocation of the participants to the study groups. In the intervention group, the trainings were as much as possible face-to-face in eight sessions (one session per week must be face-to-face) and in the form of four topics (threat understanding, problem solving, participation and evaluation) according to the model Empowerment of Alhani's family took place three times a week for 20 minutes each time
Participants/Inclusion and exclusion criteria
Inclusion criteria
Having the informed consent of the parents of children with cancer to participate in the study
Having a child under the age of 18
Parents should be able to communicate verbally
Exclusion criteria:
withdrawal of the individual during the research
The death of a child in research
Intervention groups
In the intervention group, the trainings were carried out as much as possible in person in eight sessions, the intervention was carried out according to Alhani's family-centered empowerment model, three times a week for a month and each time for 20 minutes.
Main outcome variables
Parents' quality of life, mucositis, children's quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220724055542N1
Registration date:2022-09-26, 1401/07/04
Registration timing:retrospective
Last update:2022-09-26, 1401/07/04
Update count:0
Registration date
2022-09-26, 1401/07/04
Registrant information
Name
nasim heidari farsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3226 2103
Email address
nasimh2510@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-15, 1398/03/25
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of the family-centered empowerment model based on mucositis management on the quality of life of parents and children with cancer undergoing chemotherapy
Public title
The effect of family-centered empowerment model based on mucosal management on the quality of life of parents and children with cancer undergoing chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having the informed consent of the parents of children with cancer to participate in the study
Having a child under the age of 18 with a definite diagnosis of cancer and undergoing chemotherapy
Parents should be able to communicate (speech)
. Parents not suffering from special diseases such as debilitating disease
Lack of previous participation of parents in empowerment programs
The absence of mucositis in the child at the time of entering the study
At least one month has passed since the diagnosis of the disease
Having a smartphone and virtual space9. Ability to use virtual space
Exclusion criteria:
Withdrawal of the person during the research
The death of a child in the research
Occurrence of physical or mental problems for parents to the extent that the person is not able to continue cooperation
Failure to participate in two face-to-face meetings and two online meetings
Failure to answer the questionnaire questions completely
Age
From 1 day old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
They were selected from the convenient sampling method and then divided into two intervention and control groups by random allocation method. Random allocation sequence (20 blocks of 4) was determined using Random Allocation Software. For concealment, closed envelopes containing cards with red color (for the intervention group) and blue color (for the control group) were prepared according to the predetermined allocation sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The data analyst and reasercher were blinded to the allocation of participants to study groups to ensure that all analytical decisions were made unbiased
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
e.g. No. 7, Westrahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861638137
Approval date
2020-06-14, 1399/03/25
Ethics committee reference number
IR.SKUMS.REC.1399.092
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C81-C96
ICD-10 code description
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
Primary outcomes
1
Description
mucosit
Timepoint
Before, one. Three months after the intervention.
Method of measurement
who
Secondary outcomes
1
Description
Children's quality of life
Timepoint
Before, one. Three months after the intervention.
Method of measurement
Children's quality of life questionnaire from parents' point of view (ped quality of life)
2
Description
quality of life
Timepoint
Before, one. Three months after the intervention.
Method of measurement
sf36
Intervention groups
1
Description
Control group:did not receive any training
Category
Prevention
2
Description
Intervention group: The trainings are as much as possible face-to-face in eight sessions (one session per week must be face-to-face) and in the form of four topics (threat understanding, problem solving, participation and evaluation) according to Alhani's family-centered empowerment model, three times a week and every time It took place for 20 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar and Kashani Hospital
Full name of responsible person
nasim heidari
Street address
No. 7, West rahmatieh Ave
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861637138
Phone
+98 930 886 2435
Email
nasimh2510@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Jafar Moghdisi
Street address
No. 7, West rahmatieh Ave
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861637138
Phone
+98 38 3222 3133
Email
shahriar@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahrekord Medical Sciences
Proportion provided by this source
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University OF SHAHREKORD
Full name of responsible person
Nasim Heydari Farsani
Position
NURSE
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, West DEHGHAN Ave
City
SHAHREKORD
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861638137
Phone
00933833222603
Email
NASIMH2510@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
NASIM HEIDARI FARSANI
Position
NURSE
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, West DEHGHAN Ave
City
SHAHREKORD
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861638137
Phone
+98 38 3222 2603
Email
NASIMH2510@GMAIL.COM
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
nasim heidarifarsani
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, West dehghan Ave
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8861637138
Phone
0098382262603
Email
nasimh2510@gmail.com
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