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IRCT20240707062354N2 IRCT 2025-05-17 Arak University of Medical Sciences The effect of distance nurse-led fatigue management in colorectal cancer patients The effect of distance nurse-led fatigue management on fatigue, sleep quality and self-efficacy in colorectal cancer patients (a randomized clinical trial) 2025-05-16 anticipated 60 Complete https://irct.ir/trial/83501 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Sleep quality and self-efficacy in patients with colorectal cancer.. Intervention 1: 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. Intervention 2: Control group:The control group will not receive the intervention but will receive other hospital care without any reductions. Yes - There is a plan to make this available What will be shared: All data is shared after de-identifying individuals. When: The access period starts 6 months after publication. To whom: The data will be available to researchers working in academic and scientific institutions 6 months after publication. Conditions: 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. Where to obtain: Ms. Fatemeh Moghadasi by email to the following address: fatemehmoghadasi03@gmail.com How to obtain: 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. Comments:
public Fatemeh Moghadasi
3rd floor, corner of Nizamzadeh Alley, Shahid Abdullahi Alley, Abuzar Street
Arak Iran (Islamic Republic of) 3814187476 +98 86 3221 9231 fatemehmoghadasi03@gmail.com Arak University of Medical Sciences scientific Fatemeh Moghadasi
3rd floor, corner of Nizamzadeh Alley, Shahid Abdullahi Alley, Abuzar Street
Arak Iran (Islamic Republic of) 3814187476 +98 86 3221 9231 fatemehmoghadasi03@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 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 30 years 50 years Both Known cases of multiple sclerosis, anemia, thyroid disease, orthopedic or neurological diseases such as epilepsy, of which fatigue is one of their symptoms Z73.6 Limitation of activities due to disability Behavior Behavior 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. Control group:The control group will not receive the intervention but will receive other hospital care without any reductions. Fatigue level based on the Cancer Fatigue Scale. Timepoint: At the beginning of the study (before the intervention). Method of measurement: Cancer Fatigue Scale. 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. 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. 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. 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. 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. Arak University of Medical Sciences Approved 2025-05-04 Ethics committee of Arak University of Medical Sciences University complex of the great prophet, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)