Translating Evidence-Based Self-Management Interventions Using a Stepped-Care Approach for Patients With Cancer and Their Caregivers: A Pilot Sequential Multiple Assignment Randomized Trial Design.

IF 3.3 2区 医学 Q2 ONCOLOGY Psycho‐Oncology Pub Date : 2025-01-01 DOI:10.1002/pon.70043
Sylvie Lambert, Erica E M Moodie, Jane McCusker, Marion Lokhorst, Cheryl Harris, Tori Langmuir, Eric Belzile, Andrea Maria Laizner, Lydia Ould Brahim, Sydney Wasserman, Sarah Chehayeb, Michael Vickers, Lindsay Duncan, Mary Jane Esplen, Christine Maheu, Doris Howell, Manon de Raad
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Abstract

Background: Self-directed interventions are cost-effective for patients with cancer and their family caregivers, but barriers to use can compromise adherence and efficacy.

Aim: Pilot a Sequential Multiple Assignment Randomized Trial (SMART) to develop a time-varying dyadic self-management intervention that follows a stepped-care approach in providing different types of guidance to optimize the delivery of Coping-Together, a dyadic self-directed self-management intervention.

Methods: 48 patients with cancer and their caregivers were randomized in Stage 1 to: (a) Coping-Together (included a workbook and 6 booklets) or (b) Coping-Together + lay telephone guidance. At 6 weeks, change in distress level was assessed, and non-responding dyads were re-randomized in Stage 2 to (a) continue with their Stage 1 intervention or (b) be stepped-up. Benchmarks for acceptability, feasibility, and clinical significance (anxiety and quality of life (QOL)) were assessed via surveys and study logs.

Results: Feasibility was supported by a low refusal rate at ≤ 30% and < 10% missing data. Men and women were enrolled in at least a 40:60 ratio for caregivers, but less for patients. Recruitment was slow at 1 dyad/week. Acceptability was supported by a low attrition rate (12.5%) and with 87% of participants finding the booklets helpful. Telephone guidance in Stage 1 increased adherence to Coping-Together; however, in Stage 1, participants benefited more from the self-directed format than the guidance. All patients who were stepped-up in Stage 2 benefited from their new assignment; this trend was less clear for caregivers.

Significance: Findings suggest a 3-step approach to dyadic self-management support that warrants further testing.

Trial registration: Clinical Trials Registration #: NCT04255030.

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基于证据的自我管理干预对癌症患者及其护理者的阶梯式护理:一项先导顺序多任务随机试验设计
背景:自我导向的干预措施对癌症患者及其家庭照顾者具有成本效益,但使用障碍可能影响依从性和疗效。目的:开展一项连续多任务随机试验(SMART),以开发一种时变的二元自我管理干预方法,该方法遵循分步护理方法,提供不同类型的指导,以优化“共同应对”(copin - together)的交付,这是一种二元自我管理干预方法。方法:48例癌症患者及其护理人员在第一阶段随机分为:(a)共同应对(包括一本工作手册和6本小册子)或(b)共同应对+电话指导。在第6周时,评估痛苦程度的变化,在第二阶段重新随机分配无反应的二人组,以(a)继续第一阶段的干预或(b)加强干预。通过调查和研究日志评估可接受性、可行性和临床意义(焦虑和生活质量(QOL))的基准。结果:低拒绝率≤30%支持可行性。意义:研究结果建议采用三步法进行二元自我管理支持,值得进一步测试。试验注册:临床试验注册号:NCT04255030。
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来源期刊
Psycho‐Oncology
Psycho‐Oncology 医学-心理学
CiteScore
6.30
自引率
8.30%
发文量
220
审稿时长
3-8 weeks
期刊介绍: Psycho-Oncology is concerned with the psychological, social, behavioral, and ethical aspects of cancer. This subspeciality addresses the two major psychological dimensions of cancer: the psychological responses of patients to cancer at all stages of the disease, and that of their families and caretakers; and the psychological, behavioral and social factors that may influence the disease process. Psycho-oncology is an area of multi-disciplinary interest and has boundaries with the major specialities in oncology: the clinical disciplines (surgery, medicine, pediatrics, radiotherapy), epidemiology, immunology, endocrinology, biology, pathology, bioethics, palliative care, rehabilitation medicine, clinical trials research and decision making, as well as psychiatry and psychology. This international journal is published twelve times a year and will consider contributions to research of clinical and theoretical interest. Topics covered are wide-ranging and relate to the psychosocial aspects of cancer and AIDS-related tumors, including: epidemiology, quality of life, palliative and supportive care, psychiatry, psychology, sociology, social work, nursing and educational issues. Special reviews are offered from time to time. There is a section reviewing recently published books. A society news section is available for the dissemination of information relating to meetings, conferences and other society-related topics. Summary proceedings of important national and international symposia falling within the aims of the journal are presented.
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