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IRCT20120916010844N2 IRCT 2024-05-23 Shiraz University of Medical Sciences Effect of resilience skills on caregiver burden, resilience and coping strategies in family caregivers of cancer patients Investigating the effectiveness of resilience skills training on caregiver burden, resilience and coping strategies in family caregivers of advanced cancer 2024-06-04 anticipated 114 Complete https://irct.ir/trial/73816 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The list of names of the research community (family caregivers) is prepared according to the list of patients with active cases in the chemotherapy departments where the study carried out. People are first selected based on a table of random numbers. Then, the family caregivers are allocated in two experimental and control groups using random permutation blocks of 4. The first two participants (caregivers) will be assigned to the experimental group and the next two participants (caregivers) will be assigned to the control group. The list of random blocks is set by the statistical consultant using the software. The list of random blocks prepared by the statistical consultant is placed in sealed envelopes and numbered. After selecting the patient's family caregivers, these envelopes are opened in order to assign people to the groups, and based on the content of the envelope, people are entered into one of the two experimental and control groups. This is done by opening all the envelopes until the end of the study. The sequence of random allocation is done by a statistical consultant and based on statistical software. After the sequence is prepared by the statistical consultant, it is put in the envelope by the research assistant. The sealed envelopes are given to another research assistant, and based on the contents of the envelopes, he puts people in one of the two experimental and control groups. In order to make the study blind, the help of a researcher who is not aware of the division of groups is used in collecting data and completing the questionnaires. Also, the statistician performing the data analysis will be blinded to the groups, Blinding description: In order to make the study blind, the help of a researcher who is not aware of the division of groups is used in collecting data and completing the questionnaires. Also, the statistician performing the data analysis will be blinded to the groups. N/A Cancer disease. Intervention group: The resilience training program will be conducted in 4 to 5 groups of 10 to 12 people once a week for six consecutive weeks in the form of lectures, questions and answers, telephone calls to recall and answer questions for caregivers of cancer patients. Then, immediately and one month after the sessions, in order to determine the effectiveness of this intervention, the burden of care, resilience, and coping strategies questionnaires will be completed by the participants.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no further information"
public Camellia Torabizadeh
Shiraz, Namazi Square. Fatima College of Nursing and Midwifery (S)
Shiraz Iran (Islamic Republic of) 7163613119 +98 71 3647 4254 torabik@sums.ac.ir Shiraz University of Medical Sciences scientific کاملیا ترابی زاده
Shiraz, Namazi Square. Fatima College of Nursing and Midwifery (S)
Shiraz Iran (Islamic Republic of) 7163613119 +98 71 3647 4254 torabik@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1- Willingness to participate in the study, 2- Having the age of 18 to 65 years 3- Be literate in reading and writing 4- To be responsible for patient care 5- Absence of severe diseases or psychological problems based on self-report 6- Have at least three months of history of caring of patient with advanced cancer (stage 3 and 4) 18 years 65 years Both Exclusion criteria 1. Absence in training sessions 2. Psychological crises during the study, such as the death of a close relative or bankruptcy, or a family member with severe or acute physical or mental illnesses 3-Not a member of health care team 4. Sudden changes in the patient's condition, including hospitalization or death. C00-C97 II Neoplasms Lifestyle Intervention group: The resilience training program will be conducted in 4 to 5 groups of 10 to 12 people once a week for six consecutive weeks in the form of lectures, questions and answers, telephone calls to recall and answer questions for caregivers of cancer patients. Then, immediately and one month after the sessions, in order to determine the effectiveness of this intervention, the burden of care, resilience, and coping strategies questionnaires will be completed by the participants. Caregiver burden. Timepoint: Before, immediately and a month later. Method of measurement: Zarit Burden Interview Scale. Resilience. Timepoint: Before, immediately and a month later. Method of measurement: Connor and Davidson Resilience Scale. Coping strategies. Timepoint: Before, immediately and a month later. Method of measurement: Jalowiec Coping Scale. Shiraz University of Medical Sciences Approved 2024-01-10 Ethics committee of Shiraz University of Medical Sciences Seventh floor, Shiraz University of Medical Sciences and Health Services, Next to Red Crescent Organization, Zand blvd Shiraz Fars Iran (Islamic Republic of)