Determining the Impact of Self-management program based on the 5A model on Self-Care and Quality of Life in Caregivers of Cancer Patients
Design
A single-blind,randomized,controlled clinical trial with parallel groups,conducted on 66 patients Randomization will be performed using Random Number Generator V2.
Settings and conduct
The target group will be the informal caregivers of cancer patients visiting the oncology department, on whom a self-management program based on the 5A model will be implemented for the intervention group. This study is single-blind, and the data analyst will recognize the groups by number.
Participants/Inclusion and exclusion criteria
Entry criteria:Patient caregiver willingness and consent to participate in this study؛At least a bachelor's degree or higher؛ Over 18 years of age؛Continuous care for the patient in the last 3 months (the patient has identified him as his unofficial primary caregiver)؛Lack of prominent psychological disorders and mental disorders؛Failure to participate in a similar study in the last 6 months.
Exit criteria:Dissatisfaction with continuing to participate in the study؛Failure to cooperate in filling out questionnaires؛Not attending more than 2 sessions in the second phase (5 in-person sessions in the guidance phase)؛Death of the patient؛Discontinuation of treatment؛Transfer to another treatment center؛ Change or death of the caregiver؛Mental disorders in caregivers and psychiatric visits.
Intervention groups
Intervention:in addition to routine care, which includes consultation during chemotherapy with department nurses and the use of training sheets in the department, the group will receive a 5A-based self-management program in 5 stages.
Control:routine care that includes consultation during chemotherapy with department nurses and the use of training sheets available in the Department.
Main outcome variables
Self-care ؛ quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240627062266N1
Registration date:2024-07-30, 1403/05/09
Registration timing:prospective
Last update:2024-07-30, 1403/05/09
Update count:0
Registration date
2024-07-30, 1403/05/09
Registrant information
Name
Saeedeh Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4352 2658
Email address
s.eskandari@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2024-12-10, 1403/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Self-management program based on the 5A model on Self-Care and Quality of Life in Caregivers of Cancer Patients.
Public title
The Effect of Self-Management Program on Caregivers of Cancer Patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The caregiver's willingness and consent to participate in the study
At least a bachelor's degree or higher
Age over 18 years
Continuous care for the patient in the past 3 months (the patient has identified them as their primary informal caregiver)
Lack of significant cognitive or psychiatric disorders (such as depression, psychosis, mania) and mental illnesses
No participation in a similar study in the past 6 months
Exclusion criteria:
Withdrawal of consent to continue participating in the study
Lack of cooperation in filling out questionnaires
Missing more than 2 sessions in the second phase meetings (5 in-person sessions in the guidance phase)
The patient's death
Discontinuation of treatment
Transfer to a different healthcare facility
Change or loss of the primary caregiver
The onset of psychiatric disorders in the caregiver and seeking psychiatric help
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be conducted using simple random sampling with the Random Number Generator V2 software from a list of cancer patients attending the chemotherapy department at Peymaniyeh Hospital who meet the study's inclusion criteria. Afterward, the patients' caregivers will be randomly assigned to either the intervention or control group using the Random Allocation Software V2.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical consultant will be blinded to the group assignments and will only recognize the groups by number.
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
motahari Ave., After School of Nursing., Jahrom University of Medical Sciences.
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2024-07-27, 1403/05/06
Ethics committee reference number
IR.JUMS.REC.1403.023
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average self-care score
Timepoint
before the intervention, immediately after the intervention, 3 months after the intervention
Method of measurement
PERSONAL SELF-CARE ASSESSMENT
Secondary outcomes
1
Description
Quality of life score
Timepoint
before the intervention, immediately after the intervention, 3 months after the intervention
Method of measurement
The Caregiver Quality of Life Index-Cancer scale(CQOLC)
Intervention groups
1
Description
Intervention Group: In addition to routine care, which includes consultation with nurses during chemotherapy and the use of educational leaflets available in the chemotherapy ward, the 5A model will be implemented for this group over five stages.**Stage 1: Assess (In-person)**In this stage, an initial assessment of both groups will be conducted using the following tools: the CQOLC questionnaire for the quality of life of cancer patients' caregivers and the self-care assessment questionnaire, both filled out by the researcher. This stage will be conducted individually and in person with the presence of both the researcher and the caregiver. After completing the questionnaires, the responses will be analyzed, and the individual issues of each participant in the intervention group will be listed.**Stage 2: Advise (In-person)**Based on the questionnaire results from the previous session, participants will be grouped into clusters of 5 to 7 people according to their common needs. They will receive guidance and training on the importance of self-care and methods to improve quality of life over five sessions. The educational content of these sessions will include: an introduction to cancer and symptom management, stress management, fatigue management, interaction with the patient and others, priority and personal ability management, and enhancing positive activities.**Objectives:**- Educate caregivers about effective self-care strategies and ways to improve quality of life using brochures, educational films, pamphlets, and group discussions. **Session 1: Introduction**- Topic: Introduction to Cancer and Symptom Management, Definition of Self-Management and Quality of Life * Familiarize caregivers with cancer and its symptom management, and raise awareness about the basic concepts of self-management and its importance in improving quality of life.**Session 2: Stress Management**- Topic: Training Coping Strategies to Reduce Stress and Manage Emotions * Enhance caregivers' stress management skills.**Session 3: Prioritization and Personal Capacity Management**- Topic: Training on Principles of Prioritization and Task Differentiation * Improve priority management strategies.**Session 4: Enhancing Communication Skills**- Topic: Strengthening Effective Communication and Providing Practical Advice for Improving Active Listening and Effective Expression * Improve communication skills to better manage relationships and personal needs.**Session 5: Enhancing Physical Health and Fatigue Management**- Topic: Providing Strategies for Improving Physical Health and Managing Fatigue Faced by Caregivers Daily * Encourage caregivers to adopt a healthier lifestyle, including proper nutrition, exercise, and adequate rest. * Strengthen physical health and strategies for coping with fatigue. **Stage 3: Agree (In-person)****Objectives:**- Create an individual plan for each participant detailing how to achieve the set goals.- Emphasize the importance of a regular self-care routine and persistence in self-care.After the first advice session, caregivers will be given checklists prepared by the researcher and asked to record each self-care action they perform and bring the checklists to subsequent sessions. The checklists will be based on the data collected in the Assess stage and the necessary behaviors for caregivers, determined with their input and realistic objectives. These objectives may include needs, abilities, improvement of self-care skills, stress management, and increasing positive daily activities.**Stage 4: Assist (In-person and virtual)**Caregivers will be asked to contact the researcher if they need assistance in achieving their expected goals or request an in-person meeting.- One week after the fifth session, an individual in-person meeting will be held with the researcher and caregiver to review the checklists, discuss the execution of the planned programs, and address the challenges and obstacles faced over the week. Necessary solutions will be provided to overcome these challenges.- A group will be created on Eitaa (or another virtual network chosen by the caregivers) to enable caregivers to support each other, solve challenges collectively, and share their experiences.**Stage 5: Arrange (Virtual, phone calls, and in-person)**Caregivers will be asked to continue recording their activities on the checklists for four weeks after the last advice session. During this stage, caregivers' performance will be monitored for four weeks to ensure the program's implementation. This will be followed up by the researcher through phone calls and virtual check-ins at home.Immediately after the end of the fourth week, the questionnaires will be completed again individually with the presence of the caregiver and the researcher for both the intervention and control groups. Three months later, the questionnaires will be completed again individually with the presence of the caregiver and the researcher for both groups.
Category
Lifestyle
2
Description
Control group: routine care will be provided for this group, which will include consultation with nurses during chemotherapy and the use of educational assistance sheets available in the chemotherapy department.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
oncology Department of Pymaniyeh Hospital in jahrom
Full name of responsible person
mohsen hojat
Street address
motahari Ave., After School of Nursing., Jahrom University of Medical Sciences.
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Fax
+98 71 5434 4002
Email
mohsenhojat.mh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Amir abdoli
Street address
motahari Ave., After School of Nursing., Jahrom University of Medical Sciences.
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Fax
+98 71 5434 4002
Email
info@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
Saeedeh Eskandari
Position
Master Student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No72.Shohada Ave.Saeedieh Blvd. Arsanjan,fars.
City
Jahrom
Province
Fars
Postal code
7376177118
Phone
+98 71 4352 2658
Fax
Email
s.eskandari@jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
mohsen hojat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
motahari Ave., After School of Nursing., Jahrom University of Medical Sciences.
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0407
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
Saeedeh Eskandari
Position
Master Student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No72.Shohada Ave.Saeedieh Blvd. Arsanjan,fars.
City
Jahrom
Province
Fars
Postal code
7376177118
Phone
+98 71 5434 0407
Fax
Email
s.eskandari@jums.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total individual data of study participants can be shared after people are unidentifiable.
When the data will become available and for how long
Start of the access period one year after the results are printed
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
After the completion of the work and publication of the report, upon request by researchers and with the consent of the responsible author, the data will be accessible.
From where data/document is obtainable
mohsen hojat; 00989307915244; mohsenhojat.mh@gmail.com;motahari Ave., After School of Nursing., Jahrom University of Medical Sciences.
What processes are involved for a request to access data/document
After the completion of the work and publication of the report, upon request by researchers and with the consent of the responsible author, the data will be accessible.