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一项随机对照多中心试验方案,旨在调查荒野项目对癌症影响的青少年和年轻成年人的身心健康的有效性和安全性:WAYA-2 研究。

Protocol of a randomised controlled multicentre trial investigating the effectiveness and safety of a wilderness programme on the mental and physical well-being of adolescents and young adults affected by cancer: the WAYA-2 study.

机构信息

Department of Health Sciences, Mid Sweden University, Sundsvall, Sweden

Department of Community Medicine, National Research Center in Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway Faculty of Health Sciences, Tromso, Norway.

出版信息

BMJ Open. 2024 May 21;14(5):e087626. doi: 10.1136/bmjopen-2024-087626.

Abstract

INTRODUCTION

Adolescents and young adults (AYAs) affected by cancer are an understudied group. Effective interventions are needed to support coping with the late effects of cancer, its treatment and to promote quality of life. Nature-based interventions may be promising in support of the self-management and health of AYAs affected by cancer. However, randomised controlled studies (RCTs) on the effectiveness of such interventions are lacking. We performed a first pilot RCT (n=42) that showed that it is feasible and safe to conduct such a study. Here, we propose a full-scale RCT to investigate the effectiveness and safety of a wilderness programme on the mental and physical health of AYAs affected by cancer.

METHODS AND ANALYSIS

Participants are 150 AYAs affected by cancer, aged 16-39 years, who will be randomised to a wilderness (n=75) or a hotel stay (n=75). The wilderness programme is an 8-day intervention including a 6-day wilderness expedition. This is followed 3 months later by a 4-day intervention including a 2-day basecamp. Activities include hiking, backpacking, kayaking, rock climbing, mindfulness and bush-crafting. The comparison group is an 8-day hotel stay followed by a 4-day hotel stay (interventions include two travel days) at the same hotel after 3 months. Primary outcomes are psychological well-being and nature connectedness up to 1 year after the study start. Secondary outcomes are quality of life, physical activity and safety parameters.

ETHICS AND DISSEMINATION

The Swedish Ethical Review Authority approved the study protocol on 27 September 2023 (reference: 2023-05247-01). The recruitment started on 19 February 2024 and the first part is planned to end on 31 December 2027. Study results will be disseminated by means of scientific publications, presentations at conferences, popular articles, interviews, chronicles and books. News items will be spread via social media, websites and newsletters.

TRIAL REGISTRATION NUMBER

ISRCTN93856392.

摘要

简介

受癌症影响的青少年和年轻人(AYAs)是一个研究不足的群体。需要有效的干预措施来支持应对癌症的晚期影响、其治疗并促进生活质量。基于自然的干预措施可能在支持受癌症影响的 AYA 自我管理和健康方面很有前景。然而,缺乏此类干预措施有效性的随机对照研究(RCTs)。我们进行了一项首次试点 RCT(n=42),表明进行此类研究是可行且安全的。在这里,我们提出了一项全面的 RCT,以调查荒野计划对受癌症影响的 AYA 心理健康和身体健康的有效性和安全性。

方法和分析

参与者是 150 名年龄在 16-39 岁之间受癌症影响的 AYA,他们将被随机分配到荒野组(n=75)或酒店住宿组(n=75)。荒野计划是一项为期 8 天的干预措施,包括为期 6 天的荒野探险。3 个月后,进行为期 4 天的干预,包括为期 2 天的大本营。活动包括徒步旅行、背包旅行、皮划艇、攀岩、正念和丛林生活技能。对照组是为期 8 天的酒店住宿,3 个月后在同一家酒店再进行为期 4 天的酒店住宿(干预包括两天旅行日)。主要结果是研究开始后 1 年内的心理健康和与自然的联系。次要结果是生活质量、身体活动和安全参数。

伦理和传播

瑞典伦理审查局于 2023 年 9 月 27 日批准了研究方案(参考号:2023-05247-01)。招募于 2024 年 2 月 19 日开始,第一部分计划于 2027 年 12 月 31 日结束。研究结果将通过科学出版物、会议演讲、通俗文章、采访、编年史和书籍进行传播。通过社交媒体、网站和时事通讯传播新闻项目。

试验注册号

ISRCTN93856392。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82fa/11110565/beffb038f9dc/bmjopen-2024-087626f01.jpg

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