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      Combined Effects of the Mobile Health (mHealth) Psychoeducation and Benson Relaxation Technique in Reducing the Caregiving Burden of Cancer Patients in Bangladesh: A Protocol for a Randomized Controlled Trial

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          Abstract

          Background: Chronic and noncommunicable diseases, including cancer, are a significant global public health concern. Family members or friends who serve as caregivers significantly contribute to supporting cancer patients without formal medical training. In most cases in Bangladesh, women perform caregiving activities with household responsibilities and lack adequate support from the family and healthcare systems; consequently, they face a significant burden as caregivers. This study aims to assess the effectiveness of combined mobile health (mHealth) psychoeducation and the Benson relaxation technique (BRT) on the caregiving burden among female informal caregivers of cancer patients in Bangladesh.

          Methods: We shall conduct a prospective, open-label, two-arm (1:1), randomized controlled trial in a hospital, focusing on the burden of informal female caregivers of cancer patients in Bangladesh. The combined intervention will be delivered to the intervention group through mHealth starting April 2024 and will span six months. Participants' data will be collected through face-to-face interviews using the Zarit Burden Interview (ZBI), the Hospital Anxiety Depression Scale, and the World Health Organization Quality of Life Bangla Short Instrument. Outcomes will be assessed at the baseline, midline, and endline. We shall employ descriptive statistics such as frequencies, percentages, means, and standard deviations. The t-test or Mann-Whitney U test will be used to compare continuous variables. Additionally, a two-way repeated-measures analysis of variance will be employed to evaluate the outcomes.

          Results: Participant enrollment began in January 2024, and recruitment is ongoing. The results of this study will be disseminated through publications and conferences. No external professional writers were involved in writing this manuscript.

          Conclusion: This study addresses the gap in the assessment of combined interventions for caregiver burden in Bangladesh. These outcomes may provide valuable insights into caregivers' well-being, caregiving responsibilities, and the potential for integrated interventions to reduce the burden, especially among women. If effective, we recommend the national integration of psychoeducation and BRT using mHealth.

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          SPIRIT 2013 statement: defining standard protocol items for clinical trials.

          The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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            Relatives of the Impaired Elderly: Correlates of Feelings of Burden

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              CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

              Background The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently. Methods Following a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram. Results CONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting. Conclusions The CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website (www.consort-statement.org) are helpful resources for improving the reporting of social and psychological intervention RCTs. Electronic supplementary material The online version of this article (10.1186/s13063-018-2735-z) contains supplementary material, which is available to authorized users.
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                Author and article information

                Journal
                Cureus
                Cureus
                2168-8184
                Cureus
                Cureus (Palo Alto (CA) )
                2168-8184
                4 March 2024
                March 2024
                : 16
                : 3
                : e55520
                Affiliations
                [1 ] Department of Psychosocial Rehabilitation, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, JPN
                [2 ] Department of Health Sciences, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, JPN
                [3 ] Department of Oncology, Khwaja Yunus Ali Medical College and Hospital, Sirajganj, BGD
                [4 ] Department of Public Health, Northern University, Dhaka, BGD
                [5 ] Department of Public Health and Health Policy, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, JPN
                [6 ] Department of Nutrition and Clinical Service, International Centre for Diarrhoeal Disease Research (ICDDR), Dhaka, BGD
                Author notes
                Article
                10.7759/cureus.55520
                10993085
                38576646
                772d5d1d-4e58-4444-a399-f359f1bce167
                Copyright © 2024, Roshid et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 4 March 2024
                Categories
                Psychiatry
                Public Health
                Health Policy

                bangladesh,cancer,female caregivers,informal caregivers,benson relaxation technique,psychoeducation,mhealth,caregiver burden

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