基于距离的随机对照试验，以减少前列腺癌幸存者的久坐行为：研究方案。
A distance-based, randomized controlled trial for reducing sedentary behavior among prostate cancer survivors: a study protocol.
机构信息
Faculty of Kinesiology and Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, M5S 2W6, Canada.
Faculty of Medicine, University of Toronto, 1 King's College Circle, Medical Sciences Building, Toronto, ON, M5S 1A8, Canada.
出版信息
BMC Public Health. 2022 Apr 28;22(1):855. doi: 10.1186/s12889-022-13218-5.
BACKGROUND
Prostate cancer survivors (PCS) experience long-term side effects beyond treatment such as fatigue, depression and anxiety. Quality and engaging supportive care programs are needed to reduce these chronic and debilitating effects. Independent of physical activity (PA), high volumes of sedentary behavior (SB) are associated with chronic disease-related risk factors and poorer cancer-specific quality of life (QoL). Simultaneously increasing PA and decreasing SB may be an effective health promotion strategy. Given that PCS may face several barriers to engaging in supervised programs, there is a need to develop and assess the efficacy of interventions that employ distance-based approaches for behavior change. The primary aim of this study is to determine the effects of a 12-week intervention (Fitbit + behavioral counselling) vs. Fitbit-only control group in reducing SB among PCS. Secondary outcomes include light-intensity PA, QoL, motivational outcomes, and patient satisfaction.
METHODS
This two-armed, randomized controlled trial will recruit inactive PCS (stage I-IV) across Canada who self-report engaging in >8 hours/day of SB. Participants will be randomized to the intervention (n=60; Fitbit and behavioral support) or active control group (n=60; Fitbit-only). The intervention consists of the use of a Fitbit and a series of six behavioral support sessions (two group, four individual) to aid PCS in gradually replacing SB with light-intensity PA by increasing their daily step counts to 3,000 steps above their baseline values. The Fitbit-only control condition will receive a Fitbit and public health PA resources. The primary outcome is change in SB measured objectively using activPAL inclinometers. All secondary outcomes will be measured via self-report, except for PA which will be measuring using Fitbits. Data will be collected at baseline, post-intervention, and at 6-month post-intervention.
DISCUSSION
Reducing SB and increasing light-intensity PA plays an important, yet often undervalued role in the health and well-being of PCS. This study will create a unique distance-based platform that can be used by clinical and community-based organizations as a low-cost, supportive care tool to improve health outcomes for PCS.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT05214937 . Registered January 28, 2022 Protocol version: v.1.
背景
前列腺癌幸存者（PCS）在治疗后会出现长期的副作用，如疲劳、抑郁和焦虑。需要提供高质量和有吸引力的支持性护理方案，以减轻这些慢性和衰弱性影响。独立于体力活动（PA），大量的久坐行为（SB）与慢性疾病相关的风险因素和较差的癌症特异性生活质量（QoL）有关。同时增加 PA 和减少 SB 可能是一种有效的健康促进策略。鉴于 PCS 可能面临参与监督计划的多种障碍，因此需要开发和评估采用基于距离的方法进行行为改变的干预措施的效果。本研究的主要目的是确定为期 12 周的干预（Fitbit +行为咨询）与 Fitbit 对照组相比，在减少 PCS 中 SB 方面的效果。次要结果包括低强度 PA、QoL、动机结果和患者满意度。
方法
这项双臂、随机对照试验将招募加拿大各地不活跃的 PCS（I-IV 期），他们自我报告每天>8 小时的 SB。参与者将被随机分配到干预组（n=60；Fitbit 和行为支持）或积极对照组（n=60；仅 Fitbit）。干预措施包括使用 Fitbit 和一系列六次行为支持会议（两次小组，四次个人），通过将他们的每日步数增加到比基线值高出 3000 步，帮助 PCS 逐渐用低强度 PA 代替 SB。仅 Fitbit 对照条件将收到 Fitbit 和公共卫生 PA 资源。主要结果是使用 activPAL 测斜仪客观测量的 SB 变化。所有次要结果将通过自我报告进行测量，除了 PA 将使用 Fitbits 进行测量。数据将在基线、干预后和干预后 6 个月收集。
讨论
减少 SB 和增加低强度 PA 在 PCS 的健康和福祉中发挥着重要但往往被低估的作用。这项研究将创建一个独特的基于距离的平台，可供临床和社区组织使用，作为一种低成本的支持性护理工具，以改善 PCS 的健康结果。
试验注册
ClinicalTrials.gov 标识符 NCT05214937。于 2022 年 1 月 28 日注册 协议版本：v.1。
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