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IRCT20260203068753N1 IRCT 2026-02-09 Iran University of Medical Sciences Web-Based Self-Compassion for Cancer Caregivers - Investigating the effect of web-based self-compassion training on the caregiving burden and quality of life of family caregivers of cancer patients at the end of life. 2026-02-24 anticipated 96 Complete https://irct.ir/trial/88948 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the block randomization method with blocks of four, participants will be randomly allocated into the intervention and control groups. The arrangement of the blocks will follow sequences such as ABBA, AABB, BAAB, BABA, BBAA, ABAB, and so on, and participants will be assigned to either the control or intervention group based on allocation A or B. The random block sequences will be generated using R software, Blinding description: In this study, blinding will be performed in a single-blind manner. Specifically, the statistical consultant responsible for data analysis will be kept blind to the allocation of participants to the study groups (intervention and control). After data collection, the data will be provided to the statistical consultant with coded group labels (using anonymous codes), so that he/she will not be aware of the type of intervention received by each group. N/A Self-Compassion, Caregivers’ Quality of Life, Caregiver Burden. Intervention 1: Intervention group:In the intervention group, after obtaining informed consent and completing the demographic information questionnaire, the Caregiver Burden Inventory and the Caregiver Quality of Life Index–Cancer Scale were administered. The educational content, prepared in eight sessions in the form of video clips and podcasts, was provided to participants via a link. After fully viewing the content, the instruments were completed again by the intervention group immediately and four weeks after the end of the intervention. Intervention 2: Control group: In the control group, after obtaining informed consent and completing the demographic information questionnaire, the Caregiver Burden Inventory and the Caregiver Quality of Life Index–Cancer Scale were administered. This group did not receive the educational content. The instruments were completed again by the control group immediately and four weeks after the end of the intervention. It should be noted that, after completion of the intervention and in order to observe ethical considerations, the educational content was also provided to the control group. Yes - There is a plan to make this available What will be shared: Individual Participant Data (IPD): All collected participant data will be shared after de-identification, including demographic, clinical results. Study Protocol: Full protocol including objectives, design, and analysis plan. Statistical Analysis Plan: statistical code and instructions used for analysis. Informed Consent Form: Copies of consent forms used in the study. Clinical Study Report: Complete clinical report of the study outcomes. Data Dictionary: Coding definitions and variable descriptions. When: Data and study documents will be available starting 6 months after publication of the study results To whom: Access will be granted to qualified researchers affiliated with academic, clinical, or industry institutions. Conditions: Data and documents may be used solely for academic research purposes, including re-analysis and secondary analyses, in accordance with ethical guidelines and data use agreements. Researchers must not attempt to re-identify participants. All analyses should respect participant privacy and follow approved protocols. Where to obtain: Requests for data and documents should be submitted to Dr. Zahra Alizadeh. Address: Valiasr (AJ) Street,above Vanak Square,Rashid Yassami Street,Faculty of Nursing and Midwifery, Iran University of Medical Sciences,Tehran, Iran Email: [alizadeh_z10@yahoo.com] | Phone: [+98 9122859047 ] How to obtain: Submit a formal request including a research proposal and intended analyses. Review by the principal investigator for eligibility. Sign a data use agreement. Receive access to de-identified data and related documents within 4–6 weeks of approval. Comments: All shared data will be de-identified to protect participant privacy. Users must agree to not attempt re-identification of participants.
public Zahra Alizadeh
Vali-e Asr St., Faculty of Nursing and Midwifery, Tehran, Iran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2886 alizadeh_z10@yahoo.com Iran University of Medical Sciences scientific Zahra Alizadeh
Vali-e Asr St., Faculty of Nursing and Midwifery, Tehran, Iran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2886 alizadeh_z10@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) - Participants in the study should be of both sexes and aged 18 years or older. - Caregivers (family caregivers) should have at least 6 months or more of direct caregiving experience for a patient with stage III or IV cancer. - They should be the primary caregiver of the cancer patient. - Ability to read and write. - Ability to communicate verbally and to answer the questionnaire questions. - Owning a smartphone in order to use the electronic package. - Having the skills to use a mobile phone. - Having access to stable internet and virtual/online platforms. - Ability to complete assignments after watching the sessions. - No history of psychiatric disorders based on caregivers’ self-reported verbal statements. - No use of psychiatric medications based on caregivers’ self-reported verbal statements. 18 years no limit Both - Death of the cancer patient. - Receiving other psychological interventions. - Failure to complete more than 3 out of the 7 recommended assignments. - Decision to withdraw from the study. Other Other Intervention group:In the intervention group, after obtaining informed consent and completing the demographic information questionnaire, the Caregiver Burden Inventory and the Caregiver Quality of Life Index–Cancer Scale were administered. The educational content, prepared in eight sessions in the form of video clips and podcasts, was provided to participants via a link. After fully viewing the content, the instruments were completed again by the intervention group immediately and four weeks after the end of the intervention. Control group: In the control group, after obtaining informed consent and completing the demographic information questionnaire, the Caregiver Burden Inventory and the Caregiver Quality of Life Index–Cancer Scale were administered. This group did not receive the educational content. The instruments were completed again by the control group immediately and four weeks after the end of the intervention. It should be noted that, after completion of the intervention and in order to observe ethical considerations, the educational content was also provided to the control group. Quality of life score in the Caregiver Quality of Life Index–Cancer Scale. Timepoint: Before the intervention, immediately after the intervention, and one month after the intervention. Method of measurement: The Caregiver Quality of Life Index–Cancer Scale : was developed by Weitzner and colleagues in 1997. This scale measures the impact of cancer-related illness on family caregivers in terms of physical, emotional, social, and family functioning. It consists of 35 items across four subscales. Caregiver burden score in the Caregiver Burden Inventory. Timepoint: Before the intervention, immediately after the intervention, and one month after the intervention. Method of measurement: The Caregiver Burden Inventory was developed by Novak and Guest in 1989 to assess caregiver burden. This instrument consists of 24 items organized into five subscales. Iran University of Medical Sciences Approved 2026-02-02 Ethics Committee of the School of Nursing and Midwifery, Iran University Darvazeh Shemiran, Mojahedin-e Eslam, Shahid Sayad Khodaii St., No. 64, Unit 3 Tehran Tehran Iran (Islamic Republic of)