通过监督与动机行为改变干预促进乳腺癌芳香化酶抑制剂（PAC-WOMAN）幸存者的体力活动：一项 3 臂实用随机对照试验方案。
Promoting physical activity through supervised vs motivational behavior change interventions in breast cancer survivors on aromatase inhibitors (PAC-WOMAN): protocol for a 3-arm pragmatic randomized controlled trial.
机构信息
Centro de Investigação Em Educação Física, Desporto, Saúde e Exercício (CIDEFES), Universidade Lusófona, Campo Grande 376, Lisboa, 1749-024, Portugal.
CIAFEL, Faculdade de Desporto, Universidade do Porto, Porto, Portugal.
出版信息
BMC Cancer. 2023 Jul 5;23(1):632. doi: 10.1186/s12885-023-11137-1.
BACKGROUND
Aromatase inhibitors (AI) are frequently used to treat hormone-receptor-positive breast cancer, but they have multiple adverse effects (e.g., osteoporosis, arthralgia), resulting in premature therapy discontinuation/switch. Physical activity (PA) can attenuate these negative effects and improve quality of life (QoL). However, most cancer survivors fail to perform/sustain adequate PA levels, especially in the long-term. Theory-based interventions, using evidence-based behavior change techniques, aimed at promoting long-term behavior change in breast cancer survivors are effective, but remain scarce and fail to promote self-regulatory skills and better-quality motivations associated with sustained PA adoption. This paper describes the design of the PAC-WOMAN trial, which will test the long-term effectiveness and cost-effectiveness of two state of the art, group-based interventions encouraging sustained changes in PA, sedentary behavior, and QoL. Additional aims include examining the impact of both interventions on secondary outcomes (e.g., body composition, physical function), and key moderators/mediators of short and long-term changes in primary outcomes.
METHODS
A 3-arm pragmatic randomized controlled trial, involving a 4-month intervention and a 12-month follow-up, will be implemented, in a real exercise setting, to compare: 1) brief PA counseling/motivational intervention; 2) structured exercise program vs. waiting-list control group. Study recruitment goal is 122 hormone-receptor-positive breast cancer survivors (stage I-III), on AI therapy (post-primary treatment completion) ≥ 1 month, ECOG 0-1. Outcome measures will be obtained at baseline, 4 months (i.e., post-intervention), 10 and 16 months. Process evaluation, analyzing implementation determinants, will also be conducted.
DISCUSSION
PAC-WOMAN is expected to have a relevant impact on participants PA and QoL and provide insights for the improvement of interventions designed to promote sustained adherence to active lifestyle behaviors, facilitating its translation to community settings.
TRIAL REGISTRATION
April 20, 2023 - NCT05860621. April 21, 2023 - https://doi.org/10.17605/OSF.IO/ZAQ9N April 27, 2023 - UMIN000050945.
背景
芳香化酶抑制剂（AI）常用于治疗激素受体阳性乳腺癌，但它们有多种不良反应（如骨质疏松症、关节痛），导致治疗提前中断/转换。身体活动（PA）可以减轻这些负面影响，提高生活质量（QoL）。然而，大多数癌症幸存者无法进行/维持足够的 PA 水平，尤其是在长期。基于理论的干预措施，使用基于证据的行为改变技术，旨在促进乳腺癌幸存者的长期行为改变，是有效的，但仍然很少，并且未能促进与持续 PA 采用相关的自我监管技能和更好质量的动机。本文描述了 PAC-WOMAN 试验的设计，该试验将测试两种基于最新技术的基于小组的干预措施在促进 PA、久坐行为和 QoL 的持续变化方面的长期有效性和成本效益。额外的目标包括检查这两种干预措施对次要结果（如身体成分、身体功能）的影响，以及对主要结果短期和长期变化的关键调节因素/中介因素的影响。
方法
一项 3 臂实用随机对照试验，包括 4 个月的干预和 12 个月的随访，将在实际的运动环境中实施，以比较：1）简短的 PA 咨询/动机干预；2）结构化运动方案与等待名单对照组。研究招募目标是 122 名激素受体阳性乳腺癌幸存者（I-III 期），正在接受 AI 治疗（初级治疗完成后）≥1 个月，ECOG 0-1。将在基线、4 个月（即干预后）、10 个月和 16 个月时获得结果测量值。还将进行过程评估，分析实施决定因素。
讨论
PAC-WOMAN 有望对参与者的 PA 和 QoL 产生重大影响，并为改善旨在促进积极生活方式行为持续依从的干预措施提供见解，促进其向社区环境的转化。
试验注册
2023 年 4 月 20 日-NCT05860621。2023 年 4 月 21 日-https://doi.org/10.17605/OSF.IO/ZAQ9N 2023 年 4 月 27 日-UMIN000050945。
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