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IRCT20180728040617N3 IRCT 2021-03-14 Shahroud University of Medical Sciences Effect of Stress Management Program on Psychological Distress of Cancer Patients and Caring Burden and Quality of Life of Their Caregivers Effect of Stress Management Program on Psychological Distress of Cancer Patients and Caring Burden and Quality of Life of Their Caregivers 2024-01-16 anticipated 60 Complete https://irct.ir/trial/54613 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Caregivers will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 22. According to the sample size of 60 in the present study, 15 quadruple blocks will be considered. Each caregiver will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks. N/A Cancer. Intervention 1: Intervention group: For the intervention group, 4 weekly sessions of 60 minutes are held in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. Outline of the session: (1- Stress and its effect on health, stress signs/symptoms 2- Relaxation exercises and their benefits 3- Social skills training, verbal/non-verbal communication techniques, different communication styles (aggressive, passive and assertive) 4 - Teaching coping strategies with stress (emotion-oriented and problem-oriented). Data collection tools included demographic information form, SF-36 quality of life questionnaire, Novak & Guest caring burden and Lovibond stress, anxiety and depression scale (DASS-21) which were administered by all caregivers and their patients before the intervention before the first session. (Intervention and Control Group), will be completed online. After 7 days from the end of the intervention sessions, the mentioned questionnaires will be completed to assess the effect of the intervention. Intervention 2: Control group: They will receive routine support from the treatment centre. Supporting contents will be provided to the control group after the intervention. Yes - There is a plan to make this available What will be shared: Some of the patient and caregivers' demographic information can be shared after unidentifying individuals. All of the caregivers quality of life, caring burden and patients psychological distress assessment information can be shared with caregivers after unidentified individuals. When: After publishing the article To whom: Project partners Conditions: People who do similar research Where to obtain: It will be done by email with the person in charge of the project. How to obtain: Data is made available to individuals via email. Comments:
public Seyedmohammad Mirhosseini
7th Sq, Shahroud University of Medical Sciences, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 3811 mirhoseinim@shmu.ac.ir Shahroud University of Medical Sciences scientific Hossein Ebrahimi
7th Sq, Shahroud University of Medical Sciences, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 3811 ebrahimi@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Caregiver and patient age at least 15 years. No psychological disorders in the caregiver. No drug addiction in the caregiver. No hearing or vision impairment in the caregiver. The caregiver should have the most contact with the patient. Ability to access the Internet and online mass communication software. Have the minimum ability to use smartphones and social networks. Non-participation in other supportive interventions. The caregiver should not be a member of the health care system. The caregiver is a family member of the patient. The definitive diagnosis of cancer has been made by a doctor. The stage of the disease of each patient is known Patients undergo chemotherapy. 15 years no limit Both Do not participate in the post-test. Absence from more than two sessions in support sessions. The reluctance of the caregiver to participate in the sessions. Patient death during the study Transfer the patient to other medical centers Occurrence of stressful events (except for the usual treatment process) for the patient or caregiver C00-C97 Malignant neoplasms Other N/A Intervention group: For the intervention group, 4 weekly sessions of 60 minutes are held in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. Outline of the session: (1- Stress and its effect on health, stress signs/symptoms 2- Relaxation exercises and their benefits 3- Social skills training, verbal/non-verbal communication techniques, different communication styles (aggressive, passive and assertive) 4 - Teaching coping strategies with stress (emotion-oriented and problem-oriented). Data collection tools included demographic information form, SF-36 quality of life questionnaire, Novak & Guest caring burden and Lovibond stress, anxiety and depression scale (DASS-21) which were administered by all caregivers and their patients before the intervention before the first session. (Intervention and Control Group), will be completed online. After 7 days from the end of the intervention sessions, the mentioned questionnaires will be completed to assess the effect of the intervention. Control group: They will receive routine support from the treatment centre. Supporting contents will be provided to the control group after the intervention. Caregivers Caring burden. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Novak & Guest Caring Burden Questionnaire. Caregivers Quality of Life. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Quality of Life Questionnaire SF-36. Patients' psychological distress. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Lovibond Depression, Anxiety and Stress Scale (DASS-21). Shahroud University of Medical Sciences Approved 2021-02-07 Ethics committee of Shahroud University of Medical Sciences Tehran st. Shahroud Semnan Iran (Islamic Republic of)