Investigating the effect of lifestyle education on increasing the level of awareness and performance of cancer patients in reducing complications during chemotherapy
Determining the effect of lifestyle education on increasing the level of awareness and performance of cancer patients in reducing complications during chemotherapy
Design
A clinical trial with a control group, with parallel groups, outcome-assessor blinded, randomized, phase 3 on 66 patients. Random Allocation software is used for randomization.
Settings and conduct
Cancer patients referred to Tajrish Martyrs Hospital in Tehran who are undergoing chemotherapy are included in the study. The outcome assessor does not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Having cancer based on the pathology report 2 . Candidate for chemotherapy (have not yet started chemotherapy or have completed at least one course of chemotherapy) 3. Willingness to participate in the training class on healthy lifestyle recommendations during chemotherapy. Exclusion criteria: 1. Receive other treatments such as radiotherapy at the same time as chemotherapy. 2. Do not want to be trained 3. Recent participation in similar educational and research meetings
Intervention groups
The patients in the intervention group, in addition to standard treatments and recommendations, during an educational session, healthy lifestyle recommendations during the chemotherapy period along with simple and practical solutions for cancer patients who are candidates for chemotherapy (still chemotherapy) have not started or have received at most one course of chemotherapy) is explained. The taught materials are also provided to the participants in typed form. The patients in the control group receive the usual treatments and recommendations and do not participate in the training session.
Main outcome variables
Awareness and performance of patients in reducing the side effects of chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N20
Registration date:2023-11-14, 1402/08/23
Registration timing:prospective
Last update:2023-11-14, 1402/08/23
Update count:0
Registration date
2023-11-14, 1402/08/23
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-16, 1402/08/25
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of lifestyle education on increasing the level of awareness and performance of cancer patients in reducing complications during chemotherapy
Public title
Investigating the effect of lifestyle education on increasing the level of awareness and performance of cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having cancer based on the pathology report
Candidate for chemotherapy (have not yet started chemotherapy or have completed at least one course of chemotherapy)
Willingness to participate in the training class on healthy lifestyle recommendations during the course of chemotherapy
Exclusion criteria:
Receive other treatments such as radiotherapy at the same time as chemotherapy.
Refuse to receive training
Recent participation in similar educational and research meetings
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
By using random allocation software, consecutive permutation blocks with the size of 6 people in each block are made and the patients are divided into two groups A (first treatment method) and B (second treatment method).
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the clear difference in the treatment method in each study group, blinding is done only at the level of the outcome assessor. The interventionist is different from the outcome assessor. There is no possibility of blinding the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences
Street address
Shahid Beheshti University of Medical sciences, Daneshju Blv.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.038
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
Level of awareness about side effects during chemotherapy
Timepoint
Before and after training
Method of measurement
Life style awareness questionnaire during chemotherapy
2
Description
Performance level about side effects during chemotherapy
Timepoint
Before training and after three courses of chemotherapy
Method of measurement
Questionnaire of lifestyle performance level during chemotherapy
Secondary outcomes
1
Description
Patient's quality of life
Timepoint
Before training and after three courses of chemotherapy
Method of measurement
EORTC Quality of Life Questionnaire QLQ-C30
Intervention groups
1
Description
Intervention group: In addition to common treatments and recommendations, during an educational session, healthy lifestyle recommendations during chemotherapy along with simple and practical solutions for cancer patients who are candidates for chemotherapy (have not yet started chemotherapy) or have received at most one course of chemotherapy) is explained. The taught materials are also provided to the participants in typed form. The educational content includes explanations about the treatment process (briefly about chemotherapy and its side effects), answers to participants' questions, correcting misconceptions about chemotherapy, and complete explanations about the appropriate lifestyle during chemotherapy. Lifestyle training includes recommendations on food and drinks, the amount of movement and rest, the amount of sleep and wakefulness, the control of constipation, diarrhea, nausea, and vomiting, and the temperament of patients in this course, as well as common medicine recommendations based on the content of the "Nutrition and Cancer" training course provided by WageningenX as well as the results of recent studies. It is presented to the participants through lectures, group discussions, questions and answers, and the exchange of information and experiences.
Category
Lifestyle
2
Description
Control group: They receive common treatments and recommendations and do not participate in the training session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohay-e-Tahrish Hospital
Full name of responsible person
Dr. Ghazaleh Heydarirad
Street address
Tajrish Square, Shohaday-e-Tejarish Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9201
Email
ghazalrad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
ghazalrad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@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
Demographic data and the result of the clinical trial
When the data will become available and for how long
One year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews.
From where data/document is obtainable
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
What processes are involved for a request to access data/document
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.