Resilience-Building for Advance Care Planning

Официальное название

Facilitating Advance Care Planning Discussions Between Patients With Advanced Cancer and Their Family Caregivers Using a Resilience-Building Intervention: A Randomized Controlled Trial.

Обзор

The aims of this study are to (1) assess the feasibility, acceptability, and usability of the ROCKS intervention among patients with advanced cancer and their family caregivers through a randomized controlled trial in a cancer center setting; (2) evaluate the preliminary efficacy of ROCKS, as compared to usual care, on changes in completion of advance directives; and (3) explore the dyadic effects of resilience on self-efficacy, optimism, dyadic communication and coping, anxiety, and depression using an actor-partner interdependence model.

Подробное описание

Patients with advanced cancer have not fully benefited from advance care planning due to the high levels of anxiety and depression experienced and other barriers that affect their appraisals and coping. Despite the protective effects of resilience, there have been few clinical trials improving the resilience skills of patients with advanced cancer and their family caregivers to help initiate advance care planning discussions and sustain engagement. This research evaluates the impact of a web-based resilience-building intervention called ROCKS on enhancing the completion of advance directives, as well as improving resilience, coping, anxiety, and depression among patients with advanced cancer and their family caregivers.

Вмешательства

• Поведенческое ROCKS
  The intervention will be provided to participants to strengthen optimism, communication skills, knowledge, and self-efficacy to support patients and family caregivers in engaging in advance care planning discussions.
• Поведенческое Usual Care
  An advance directive called Five Wishes will be provided to participants to increase their knowledge about advance care planning.

Первичные конечные точки

• Completion of advance directives [Срок оценки: Week 8]

Вторичные конечные точки (7)

• Resilience [Срок оценки: Week 8]
• Optimism [Срок оценки: Week 8]
• Dyadic communication and coping [Срок оценки: Week 8]
• Knowledge [Срок оценки: Week 8]
• Self-efficacy [Срок оценки: Week 8]
• Anxiety [Срок оценки: Week 8]
• Depression [Срок оценки: Week 8]

Критерии участия

Критерии включения

• Eligible patients will (1) be ≥ 18 years of age; (2) be diagnosed with stage 3 or 4 cancer; and (3) have a family caregiver who is willing to participate.
• Eligible family caregivers will be ≥ 18 years of age. All participants must be able to read, write, and speak English with minimal assistance from others and have access to the internet on a smartphone, laptop, or computer.

Критерии исключения

• Patient participants will be ineligible if they have (1) a Short Portable Mental Status Questionnaire (SPMSQ) score < 8; or (2) have completed any form of advance directive.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Illinois Chicago — Chicago

Идентификаторы

NCT: NCT07428278 · 2023-0430: Aim 4-6 · R00NR020358

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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