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IRCT20250726066640N1 IRCT 2025-10-20 Jahrom University of Medical Sciences Investigating the impact of the careSTEPS intervention on caregivers of cancer patients careSTEPS Investigating the effect of careSTEPS intervention on general health, care burden and quality of life of caregivers of cancer patients 2025-11-22 anticipated 94 Complete https://irct.ir/trial/85732 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: After approving the plan and receiving the code of ethics from the Honorable Vice President of Research, a letter will be received to start sampling at Imam Hassan Mojtaba (AS) Hospital in Darab. The researcher, as an active observer and interventionist, will call a few weeks before the intervention to announce the call, and after the caregivers complete a written consent form, will take the sample and review the inclusion criteria. Simple random sampling will be performed using the Random Number Generator V2 software from the list of caregivers of cancer patients referred to the insurance unit of Imam Hassan Mojtaba (AS) Hospital in Darab who meet the inclusion criteria for the study, and then the caregivers will be divided into two intervention and control groups by simple random allocation using the Random Allocation Software V2 software, Blinding description: Participant blinding: Lack of knowledge of how the intervention was implemented Researcher blinding: Distribution of questionnaires by another person who is unaware of how the intervention was implemented Data analyst blinding: Data are recorded with a numerical number and there is no indication of which group they belong to. N/A caregivers of patients with various types of cancers. Intervention 1: Intervention group: Conducting 6 in-person training sessions on the topics of self-care, improving communication, managing symptoms, problem-solving skills, and social support. Intervention 2: Control group: For the control group, no specific intervention will be carried out by the researchers, but after the intervention is implemented, if it is effective, due to compliance with research ethics, two in-person training sessions will be held for the caregivers of the control group. Pamphlets and educational content for the virtual group will also be made available to them. Yes - There is a plan to make this available What will be shared: Statistical data will be published without naming individuals. When: It depends on the opinion of the advisors and supervisors. To whom: The data from this study will be available to clinicians and researchers alike. Conditions: They will be allowed to use the data according to the laws. Where to obtain: After the article is published in journals, it is printed through the journal. How to obtain: First, the request should be sent to the responsible author. After review, the information will be provided by him/her. Comments:
public Mohsen Hojat
Office of the president and deputy of development jahrom university of medical sciences, end of shahid beheshti blvd, jahrom, fars province,iran
Jahrom Iran (Islamic Republic of) 74148-46199 +98 71 5447 5601 Mohsenhojat.mh@gmail.com Jahrom University of Medical Sciences scientific Mohsen Hojat
Office of the president and deputy of development, jahrom university of medical sciences, end of shahid beheshti blvd, jahrom, fars province,iran
Jahrom Iran (Islamic Republic of) 74148-46199 +98 71 5447 5601 Mohsenhojat.mh@gmail.com Jahrom University of Medical Sciences Iran (Islamic Republic of) Patient caregiver's willingness and consent to participate in this study Being literate Absence of psychological disorders (depression, psychosis, and mania) and mental disorders based on self-report Not participating in a similar study in the past 6 months The person identified by the patient or their companion as the patient's primary caregiver Access to mobile or landline phone Over 18 years old 18 years no limit Both Lack of cooperation in completing questionnaires Failure to attend meetings more than 2 times Patient death Discontinuation of treatment for any reason Moving, relocating, and emigrating to another village, city, or country Change or death of primary caregiver Occurrence of mental disorders in the caregiver and referral to a psychiatrist C80.1 Malignant (primary) neoplasm, unspecified N/A N/A Intervention group: Conducting 6 in-person training sessions on the topics of self-care, improving communication, managing symptoms, problem-solving skills, and social support. Control group: For the control group, no specific intervention will be carried out by the researchers, but after the intervention is implemented, if it is effective, due to compliance with research ethics, two in-person training sessions will be held for the caregivers of the control group. Pamphlets and educational content for the virtual group will also be made available to them. Burden of care- general health- quality of life. Timepoint: Before and one month after the intervention. Method of measurement: CHQ-28-Zarit questionnaires - Quality of Life Questionnaire for Caregivers of Cancer Patients. Quality of life. Timepoint: Before and one month after the intervention. Method of measurement: Cancer Caregiver Quality of Life Questionnaire CQOLC7. General health. Timepoint: Before and one month after the intervention. Method of measurement: GHQ-28) General Health Self-Report Scale. Burden of care. Timepoint: Before and one month after the intervention. Method of measurement: Zarit Caregiver Burden Questionnaire. Jahrom University of Medical Sciences Approved 2025-08-19 Ethical committee of jahrom university of medical sciences Office of the president and deputy of development jahrom universityof medical sciences end of shahid beheshti blvd Jahrom Fars Iran (Islamic Republic of)