The effect of distance nurse-led fatigue management on fatigue, sleep quality and self-efficacy in colorectal cancer patients (a randomized clinical trial)
Determining the effect of distance nurse-led fatigue management on fatigue, sleep quality and self-efficacy in colorectal cancer patients
Design
Clinical trial with intervention and control group, without blinding, randomized, on 60 patients. Alternative block randomization technique was used for randomization.
Settings and conduct
Eligible patients visiting Ayatollah Khansari Hospital in Arak will be enrolled in this non-blinded, two-group clinical trial. The intervention group will receive fatigue management training via non-face-to-face sessions through Skyroom, while the control group will continue to receive standard hospital care without the intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30-50 years; Be able to read and write and fluent in Persian; The patient or their family members must have the ability and facilities to use the Skyroom platform; Interested in participating in the study; The diagnosis of colorectal cancer has been confirmed by a specialist physician; Do not have a clear mental disorder or physical illness that results in limited mobility; At least one chemotherapy session has begun; The patient's chemotherapy sessions should be outpatient. Exclusion criteria: Known cases of multiple sclerosis, anemia, thyroid disease, orthopedic or neurological diseases such as epilepsy, of which fatigue is one of their symptoms
Intervention groups
The intervention group will participate in fatigue management training guided by a nurse. This training will be conducted via Skyroom. Meanwhile, the control group will continue to receive comprehensive standard hospital care without this specific intervention.
Main outcome variables
Fatigue; sleep quality; self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240707062354N2
Registration date:2025-05-17, 1404/02/27
Registration timing:registered_while_recruiting
Last update:2025-05-17, 1404/02/27
Update count:0
Registration date
2025-05-17, 1404/02/27
Registrant information
Name
Fatemeh Moghadasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3221 9231
Email address
fatemehmoghadasi03@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-16, 1404/02/26
Expected recruitment end date
2026-05-16, 1405/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of distance nurse-led fatigue management on fatigue, sleep quality and self-efficacy in colorectal cancer patients (a randomized clinical trial)
Public title
The effect of distance nurse-led fatigue management in colorectal cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-50 years
Be able to read and write and fluent in Persian
The patient or their family members must have the ability and facilities to use the Skyroom platform.
Interested in participating in the study
The diagnosis of colorectal cancer has been confirmed by a specialist physician
Do not have a clear mental disorder or physical illness that results in limited mobility
At least one chemotherapy session has begun
The patient's chemotherapy sessions should be outpatient
Exclusion criteria:
Known cases of multiple sclerosis, anemia, thyroid disease, orthopedic or neurological diseases such as epilepsy, of which fatigue is one of their symptoms
Age
From 30 years old to 50 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
The research units will be selected as available and then randomly allocated in two intervention and control groups using the alternative block randomization technique.10 blocks with 6 modes will be used. The letter A will represent the participant of the intervention group and the letter B will represent the participant of the control group. The samples in the two intervention and control groups will be randomly selected from among the blocks based on the sequence of entry and according to the block pattern and will be assigned to the intervention and control groups.
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 Arak University of Medical Sciences
Street address
University complex of the great prophet, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2025-05-04, 1404/02/14
Ethics committee reference number
IR.ARAKMU.REC.1404.041
Health conditions studied
1
Description of health condition studied
Sleep quality and self-efficacy in patients with colorectal cancer.
ICD-10 code
Z73.6
ICD-10 code description
Limitation of activities due to disability
Primary outcomes
1
Description
Fatigue level based on the Cancer Fatigue Scale
Timepoint
At the beginning of the study (before the intervention)
Method of measurement
Cancer Fatigue Scale
2
Description
Sleep quality based on the Pittsburgh Sleep Quality Index questionnaire
Timepoint
At the beginning of the study (before the intervention)
Method of measurement
Pittsburgh Sleep Quality Index Questionnaire
3
Description
Self-efficacy level based on Schwartz General Self-Efficacy Scale
Timepoint
At the beginning of the study (before the intervention)
Method of measurement
Schwartz General Self-Efficacy Scale
Secondary outcomes
1
Description
Fatigue level based on the Cancer Fatigue Scale at the end of the intervention
Timepoint
At the end of the intervention
Method of measurement
Cancer Fatigue Scale
2
Description
Sleep quality based on the Pittsburgh Sleep Quality Index Questionnaire at the end of the intervention
Timepoint
at the end of the intervention
Method of measurement
Pittsburgh Sleep Quality Index Questionnaire
3
Description
Self-efficacy level based on Schwartz General Self-Efficacy Scale at the end of the intervention
Timepoint
At the end of the intervention
Method of measurement
Schwartz General Self-Efficacy Scale
Intervention groups
1
Description
Intervention group:The intervention group will participate in fatigue management training guided by a nurse. This training will be conducted via Skyroom which will cover strategies for energy conservation, relaxation breathing exercises, sleep hygiene education, and home exercise protocols. Each subject will be covered in two sessions, totaling eight sessions, with each session lasting between 60 to 90 minutes. Each week, a non-face-to-face training session and telephone follow-up by a nurse will be conducted once a week (for at least 15 minutes) based on the training content of the previous session and patient assessment will be conducted based on an implicit checklist that can be changed based on the training content of each session. The Fatigue Scale, Pittsburgh Sleep Quality Index, and Schwartz General Self-Efficacy Scale will be completed by both groups after the intervention.
Category
Behavior
2
Description
Control group:The control group will not receive the intervention but will receive other hospital care without any reductions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital, Arak city
Full name of responsible person
Fatemeh Moghadasi
Street address
Ayatollah Khansari Hospital, End of University Street, Arak city, Central province
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
info_khansari@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Behzad Khansarinejad
Street address
University complex of the great prophet, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3383 8319
Email
behzad.khansarinejad@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Moghadasi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
3rd floor, corner of Nizamzadeh Alley, Shahid Abdullahi Alley, Abuzar Street
City
Arak
Province
Markazi
Postal code
3814187476
Phone
+98 86 3221 9231
Email
fatemehmoghadasi03@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Moghadasi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
3rd floor, corner of Nizamzadeh Alley, Shahid Abdullahi Alley, Abuzar Street
City
Arak
Province
Markazi
Postal code
3814187476
Phone
+98 86 3221 9231
Email
fatemehmoghadasi03@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Moghadasi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
3rd floor, corner of Nizamzadeh Alley, Shahid Abdullahi Alley, Abuzar Street
City
Arak
Province
Markazi
Postal code
3814187476
Phone
+98 86 3221 9231
Email
fatemehmoghadasi03@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 data is shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions 6 months after publication.
Under which criteria data/document could be used
6 months after the publication of the results, researchers working in academic and scientific institutions can refer to Ms. Fatemeh Moghadasi, the person in charge of the project, and use the data of the project by mentioning the source.
From where data/document is obtainable
Ms. Fatemeh Moghadasi by email to the following address: fatemehmoghadasi03@gmail.com
What processes are involved for a request to access data/document
6 months after the results are published, the applicant can contact the person in charge of the project, Ms. Fatemeh Moghadasi, at the following email address. fatemehmoghadasi03@gmail.com And between 7 - 10 days later, the documents and data files will reach them.