Investigating the effect of family and patient-centered empowerment program on quality of life and quality of social communication in patients with colorectal cancer: A clinical trial study
To Investigate the effect of family and patient-centered empowerment program on quality of life and quality of social communication in patients with colorectal cancer
Design
Clinical trial with control group, randomized, with parallel groups, design of 60 patients
Settings and conduct
The samples were selected from among all colorectal cancer patients referred to the chemotherapy department of Peymaniyeh Hospital in Jahrom city were randomly divided into two intervention and control groups.
The case group will receive the empowerment program in addition to routine care in 8 training sessions, twice a week in the form of lectures, questions and answers, film screenings, an educational pamphlet. Primary caregivers will be present with patients in all training sessions.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
- Patient and primary caregiver's willingness and consent to participate in the study.
- Patient and primary caregiver's ability to read and write.
- Patient and primary caregiver must be over 18 years of age.
- The diagnosis of colorectal cancer must be confirmed by an oncologist
Exclusion Criteria
- Suffering from obvious psychological disorders (such as depression, psychosis, mania) and mental disorders of the patient and the main caregiver
Intervention groups
Intervention group
This stage will be carried out in four steps through group discussion sessions for patients and their families.
First Step (Perceived Threat), Second Step (Self-Efficacy Promotion), Third Step (Self-Esteem Enhancement) and Fourth Step (Final Evaluation).
Control Group
The control group will receive routine care.
Main outcome variables
quality of life; quality of social communication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230730058966N2
Registration date:2024-11-18, 1403/08/28
Registration timing:prospective
Last update:2024-11-18, 1403/08/28
Update count:0
Registration date
2024-11-18, 1403/08/28
Registrant information
Name
mahdi karimyar jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5422 1520
Email address
mahdikarimyar310@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of family and patient-centered empowerment program on quality of life and quality of social communication in patients with colorectal cancer: A clinical trial study
Public title
family and patient-centered empowerment in colorectal cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient and primary caregiver's willingness and consent to participate in the study
Patient and primary caregiver's ability to read and write
Patient and primary caregiver must be over 18 years of age
The patient and primary caregiver must not have psychiatric disorders (such as depression, psychosis, mania) or mental disorders
The primary caregiver should live with the patient
The primary caregiver must be an active member of the patient's care
The diagnosis of colorectal cancer must be confirmed by an oncologist
Exclusion criteria:
Absence of the primary caregiver and the patient for more than 2 sessions
Death or migration of the patient
Lack of cooperation or willingness of the primary caregiver to continue participating in the study
Incomplete filling of questionnaires by the patient
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, a list of selected samples is prepared and numbered in order. Then, with the help of "Random Number Generator" software, each of the even numbers obtained in each selection will be assigned to the control group and the odd numbers will be assigned to the case group.
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
Research Ethics Committees of Jahrom University of Medical Sciences
Street address
Deputy of Research and Technology, Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2024-10-16, 1403/07/25
Ethics committee reference number
IR.JUMS.REC.1403.069
Health conditions studied
1
Description of health condition studied
colorectal cancer patients
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
Primary outcomes
1
Description
quality of life
Timepoint
before intervention and immediately and 1 month after intervention
Method of measurement
The Quality of Life Questionnaire for Colorectal Cancer Patients (QLQ-CRC)
2
Description
quality of social communication
Timepoint
before intervention and immediately and 1 month after intervention
Method of measurement
The Social Relationship Quality Scale (SRQS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This stage will be carried out in four steps through group discussion sessions for patients and their families. In this stage, based on the results obtained from the questionnaires in the previous session, individuals will be categorized into groups of 5 to 7 people with common needs, and guidance and training related to emphasizing the importance of improving social relationships and methods to improve the quality of life of patients will be provided in four steps over 8 sessions.First Step (Perceived Threat): Includes perceived severity and sensitivity. This step will be conducted in 2 sessions using educational pamphlets and films, and the educational content will include: familiarity with the anatomy and physiology of the intestine and digestive system, acquaintance with colorectal cancer and its treatment methods, symptom management (prevention and reduction of nausea and vomiting, skin and hair damage, fatigue, defecation problems), and mentioning specific examples of their own symptoms. In these sessions, the researcher will have a supportive, guiding, and participatory educational role. The duration of each session will be 40 to 60 minutes, depending on the patients' preference. At the end of each session, there will be a summary and a question-and-answer session, and an educational card containing the session materials will be provided to the patient and the primary caregiver.Second Step (Self-Efficacy Promotion): Four 1-hour sessions will be held using the problem-solving method or group problem-solving. Patients will start the discussion by mentioning their own problems, and their problems will be identified, defined, and prioritized by themselves, then skillful solutions will be taught through scientific demonstration and group discussion. Patients and their families will participate in suggesting and choosing solutions. In these sessions, issues such as self-care in colorectal cancer, family involvement, management of negative emotions and psychological issues (reducing anxiety and depression, stress, and anger), mindfulness, improving sleep patterns, defecation patterns, ways to promote spiritual activity, improving social interactions, increasing positive activities, scheduling a written reminder of medication time, observing health points, and managing fatigue will also be discussed, and muscle relaxation techniques and sports exercises will be demonstrated.Based on the group discussion, the researcher will realize:1- To what extent the educational content has been successfully conveyed 2- Points that have not been conveyed to the patients and active family members will be discussed, and 3- Questions from the active family member and the patient will be answered. In this stage, patients and their families will mentally and practically believe that they can prevent and control the consequences of chemotherapy and its side effects by self-control and adopting preventive behaviors. Patients and active family members will study the pamphlets and ask questions on the subject to the researcher.Third Step (Self-Esteem Enhancement): This step will be conducted using the participatory education method in 1 session. The patient will learn the topics and skills with their active family member. The active family members and the patient will be asked to discuss the topics they will be taught and what they will learn from the educational pamphlets and films under the supervision of the researcher. Then, patients will be asked to practice and repeat the behaviors and skills they have learned to become self-sufficient to the extent that they can perform them without the presence of the researcher. The feeling of learning, the feeling of being able to do so, and receiving encouragement from themselves and the researcher will increase the patient's self-sufficiency and, consequently, their self-esteem. Also, during the self-efficacy and self-esteem intervention, the researcher will evaluate the level of adopting preventive behaviors in each session by asking questions about the correct implementation or elimination of the wrong behavior in relation to the previous session. In these sessions, topics will be expressed by the active family member and the patient, and the researcher will play a facilitating role.Fourth Step (Final Evaluation): The final evaluation will be conducted in 1 session immediately after and one month after the end of the empowerment model. The perceived threat will be evaluated by asking questions about the content of the previous sessions. Self-efficacy will be evaluated by performing the taught skills (such as muscle relaxation techniques, sports movements, etc.). Self-esteem will be evaluated by asking and assessing the level of cooperation and interest of the patient and family in educational participation.
Category
Rehabilitation
2
Description
Control group: The control group will receive routine care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Peymaneh Hospital of Jahrom University of Medical Sciences
Full name of responsible person
Mahdi KarimyarJahromi
Street address
Peymanyeh Hospital, Vali-Asr st. Jahrom
City
Jahrom
Province
Fars
Postal code
7419886688
Phone
+98 71 5423 0011
Email
mahdikarirmyar310@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
Deputy of Research and Technology, Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
a.abdoli@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
Mahdi Karimyar Jahromi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.16, Ebrat st, Jahrom
City
Jahrom
Province
Fars
Postal code
7419653846
Phone
+98 71 5422 1520
Email
mahdikarirmyar310@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mahdi Karimyar Jahromi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 16, Ebrat st, Jahrom
City
Jahrom
Province
Fars
Postal code
7419653846
Phone
+98 71 5422 1520
Email
mahdikarirmyar310@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mahdi Karimyar Jahromi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 16, Ebrat st. Jahrom
City
Jahrom
Province
Fars
Postal code
7419653846
Phone
+98 71 5422 1520
Email
mahdikarirmyar310@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
No - There is not 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 collected deidentified IPD
When the data will become available and for how long
starting immediately after publication
To whom data/document is available
all people
Under which criteria data/document could be used
There is no special condition. Any request will be answered by email. There will be no specific restrictions on the use of data or documents.
From where data/document is obtainable
Request by email to:
mahdikarimyar310@gmail.com
What processes are involved for a request to access data/document
If the request is received by email, it will be answered as soon as possible.