Investigating the effect of family-centered empowerment on the quality of life and self-efficacy in cancer patients undergoing chemotherapy in Shariati Fasa Hospital
Studying the effect of family-centered empowerment on the quality of life and self-efficacy of cancer patients undergoing chemotherapy at Shariati Hospital, Fasa, in 2025.
Design
In this study, the sample size was determined with a confidence level of 95%, a test power of 80%, and based on the results of the study by Masoudi et al. (35), considering the possibility of sample attrition and with the aim of improving the statistical power of the tests, 40 people were determined for each group, for a total of 80 people. Volunteers who met the entry requirements for the study were divided into two intervention and control groups based on the random selection software. The randomization method of individuals into two groups was performed using the Balanced Block Randomization method in the form of Random Allocation software in a one-to-one ratio.
Settings and conduct
The study was conducted at Shariati Hospital in Fasa County.
Participants/Inclusion and exclusion criteria
I. c.: At least two months after cancer diagnosis, age 30 to 60 years, having a caregiver or active family member.
E. c.: Unwillingness to continue participating
Intervention groups
For the test group, the family-centered empowerment program is implemented based on the steps of the empowerment model.
The steps of the family-centered empowerment model are in order and in 4 main steps: 1- Understanding the threat, 2- Improving self-efficacy/problem solving, 3- Improving self-confidence and self-esteem through educational participation, and 4- Evaluation.
Main outcome variables
quality of life, self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250611066184N1
Registration date:2025-08-05, 1404/05/14
Registration timing:prospective
Last update:2025-08-05, 1404/05/14
Update count:0
Registration date
2025-08-05, 1404/05/14
Registrant information
Name
Azam Zare Banadkoki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 6324
Email address
a.zarebanad@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-21, 1404/07/29
Expected recruitment end date
2026-02-08, 1404/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of family-centered empowerment on the quality of life and self-efficacy in cancer patients undergoing chemotherapy in Shariati Fasa Hospital
Public title
Investigating the effect of family-centered empowerment on the quality of life and self-efficacy in cancer patients undergoing chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least two months have passed since the diagnosis of cancer
, having a caregiver or active family member
not suffering from serious and debilitating complications of cancer
undergoing chemotherapy
able to speak and communicate
able to read and write
not suffering from another chronic disease
adults aged 30 to 60 years
willing to participate in the study
, interested and able to learn the material
Exclusion criteria:
Absence of more than one session in training sessions
unwillingness to continue cooperation in the present study.
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who are willing and meet the entry requirements for the study are divided into two groups: intervention and control based on the random selection software. The randomization method of individuals into two groups is carried out using the Balanced Block Randomization method in the Random Allocation software in a one-to-one ratio.
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 Fasa University of Medical Sciences
Street address
Abn Sina Squre
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Approval date
2024-10-26, 1403/08/05
Ethics committee reference number
IR.FUMS.REC.1403.088
Health conditions studied
1
Description of health condition studied
in cancer patients undergoing chemotherapy
ICD-10 code
Z51.11
ICD-10 code description
Encounter for antineoplastic chemotherapy
Primary outcomes
1
Description
quality of life
Timepoint
before, after and 2 month after
Method of measurement
To assess quality of life, a specific questionnaire for measuring quality of life in cancer patients, developed by Arneson in 1987, is used. This questionnaire was standardized by Montazeri and colleagues in Iran.
Secondary outcomes
1
Description
self efficacy
Timepoint
before, after and two month after
Method of measurement
The Self-Care Self-Efficacy Questionnaire was first designed by Lu in 1996 for cancer patients and was translated into a Persian version and used by Azizi.
Intervention groups
1
Description
Intervention group: Before the intervention, the demographic characteristics checklist, quality of life questionnaire, and self-efficacy questionnaire are completed by the intervention group. And a pre-test is taken from the sample units. For the test group, the family-centered empowerment program is based on the steps of the empowerment model and according to the designed educational program. The first step (perception of threat) sessions will be held in groups of 10 people, consisting of 5 patients and 5 family members (one member of the main family caregiver), in the form of discussion and exchange of opinions and questions and answers by the researcher in one of the hospital meeting rooms using educational aids such as whiteboards, projectors, and PowerPoint. After selecting the first 5 patients, the first step empowerment sessions will be held with a family member of the patient, and the subsequent sessions for the subsequent steps will be held individually (one patient and one family member). The interval between sessions will be between 5 and 7 days, depending on the patient and the family caregiver. The patient will participate in these sessions with the family caregiver. The researcher will have the role of educational, supportive, and guiding participation. The intervention stages are as follows:. The steps of the family-centered empowerment model will be carried out in four main steps: 1- Understanding the threat, 2- Promoting self-efficacy/problem solving, 3- Promoting self-confidence and self-esteem through educational participation, and 4- Evaluation: 1. Step 1, Understanding the threat: The first step in the family-centered empowerment model is to increase perceived severity and sensitivity. The purpose of perceived severity (awareness and knowledge of the individual about the disease) is for the individual to understand the seriousness of the disease by recognizing the risks or complications of the disease and to feel threatened by it. In order to sensitize and increase the level of information of patients and their families, group sessions will be held on the nature of the disease, symptoms, complications, prognosis of the disease, diet, treatment regimen, physical activities, and laboratory tests during two sessions (each session 40 to 60 minutes) with educational aids. At the end of the training sessions, questions and answers will be held to ensure understanding of the material. Both the patient and the family caregiver will participate in the discussions and their problems will be identified, discussed and prioritized. 2. The second step, self-efficacy: Problem solving or problem solving will be implemented in a group method. For this purpose, problem solving sessions (two 40-60 minute sessions) will be held for a group of patients and their families. In these sessions, patients and families will practically face problems and the problem-solving process. In these two sessions, the skills necessary for better disease control will be explained and practiced. Then, patients and families will be asked to practice this skill. For example, one of the problems faced by patients undergoing chemotherapy is nausea and vomiting, and the type of drug that controls this condition and the dosage amount will be demonstrated in class. Also, with regard to the condition of hair loss, how to use a wig will be taught and practiced. 3. Step Three, Self-Belief and Increased Self-Confidence: In this step, the patient will be asked to teach the family the material discussed in the previous sessions during a session and to do so with the researcher's help and guidance if needed. The goal of this step is to increase the patients' self-confidence due to observing their ability to provide information to family members and support the family. 4. Step Four, Evaluation: Evaluation consists of 2 steps. 1- Process evaluation 2- Final evaluation 5. Process evaluation will be carried out during the empowerment sessions in such a way that the educational materials of the previous sessions will be evaluated in the form of questions and answers in the next session. The final evaluation will be carried out immediately and two months after the intervention, quality of life and self-efficacy questionnaires will be completed by both intervention groups. And a post-test will be taken again. During this period, the researcher will follow up with the patient and the family caregiver via telephone call. Follow-up and telephone call will be made every 5 days for 5 to 10 minutes to answer their questions.
Category
Lifestyle
2
Description
Control group: Initially, the demographic characteristics checklist, quality of life questionnaire, and efficacy questionnaire are completed by the control group and a pre-test is administered to them. The control group receives training in the form of lectures and face-to-face according to the routine of the inpatient ward. Considering that the training received by patients is during hospitalization and at the time of discharge from the hospital, the quality of life questionnaire and self-efficacy questionnaire are completed again at the time of discharge, and a post-test is also administered. In the following two months, the quality of life and self-efficacy questionnaires are completed and the post-test is administered again.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Fasa Hospital
Full name of responsible person
Azam Zare
Street address
Ibn-al sina square
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5335 0994
Email
info@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Ibn-sina square
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5335 0994
Email
info@fums.ac.ir
Grant name
Office of Research, Fasa University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Azam Zare
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ibn- sina square
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5335 0994
Email
a.zare2002@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Azam Zare
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ibn-sina square
City
fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5335 0994
Email
a.zare2002@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Azam Zare
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ibn-sina square
City
fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5335 0994
Email
a.zare2002@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
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
All potential data is shareable after individuals are de-identified.
When the data will become available and for how long
Access begins 4 months after results are published.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
To write meta-analysis studies
From where data/document is obtainable
Dr. Azam Zare - Fasa University of Medical Sciences
What processes are involved for a request to access data/document