Franco Sofia, Carraça Eliana V, Nobre Inês, Rodrigues Bruno, Ilharco Vítor, Kahlert Lea, Silva Marlene N
CIDEFES Centro de Investigação em Educação Física, Desporto, Exercício e Saúde, Universidade Lusófona, Lisbon, Portugal.
Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz Quebrada, Lisbon, Portugal.
Pilot Feasibility Stud. 2025 Jan 11;11(1):4. doi: 10.1186/s40814-024-01587-0.
Despite the benefits of physical activity (PA), cancer survivors report engagement barriers, and existing interventions often lack comprehensive solutions. Theory-based interventions using evidence-based behavior change techniques (BCTs) have been shown to be effective in promoting PA for breast cancer survivors, although their feasibility and acceptability lack evidence. The PAC-WOMAN trial is a three-arm randomized controlled trial aimed at promoting short- and long-term PA and improving the quality of life of breast cancer survivors. This study describes the development of a brief counseling theory-based motivational intervention from the PAC-WOMAN trial, assessing its feasibility and acceptability.
A broad search of theory-based interventions for people with chronic diseases was conducted. Key strategies from each intervention helped shape the main components and BCTs used in the eight bimonthly sessions of the PAC-WOMAN brief counseling intervention, which was based on self-determination theory principles and aimed at empowering participants to develop self-regulation resources for PA through basic psychological needs satisfaction. A toolkit and manuals for intervention facilitators and participants were developed. A feasibility study was conducted to monitor implementation fidelity, acceptability, adherence, and participants' experiences (via a focus group).
Twelve women (mean age 55.9 ± 6.7 years) participated. Implementation monitoring indicated that the intervention was feasible. The attrition rate was 25%. Focus-group discussion suggested that weekly sessions would increase attendance, highlighted the helpfulness of self-monitoring and the importance of role models for PA, and identified the session on safely exercising at home as key in improving PA levels.
This research aims to enhance systematic reporting in intervention development by detailing the specific BCTs used, translating them into implementation strategies, providing comprehensive resources for facilitators/participants, and supporting the implementation, dissemination, and adoption of a theory-based intervention informed by previous research. Feasibility testing suggests that the intervention was well accepted by participants and feasible, although it could benefit from adjustments in format to increase compliance.
NCT05860621, registered 20 April 2023 - retrospectively registered, https://clinicaltrials.gov/study/NCT05860621 . Registered 21 April 2023 - retrospectively registered, https://doi.org/10.17605/OSF.IO/ZAQ9N . UMIN000050945, registered 27 April 2023 - retrospectively registered, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058070 .
尽管体育活动(PA)有益,但癌症幸存者报告了参与障碍,而且现有的干预措施往往缺乏全面的解决方案。使用循证行为改变技术(BCTs)的基于理论的干预措施已被证明在促进乳腺癌幸存者的体育活动方面是有效的,尽管其可行性和可接受性缺乏证据。PAC-WOMAN试验是一项三臂随机对照试验,旨在促进乳腺癌幸存者的短期和长期体育活动,并改善其生活质量。本研究描述了PAC-WOMAN试验中一种基于简短咨询理论的动机干预措施的开发过程,评估了其可行性和可接受性。
对针对慢性病患者的基于理论的干预措施进行了广泛搜索。每项干预措施的关键策略有助于塑造PAC-WOMAN简短咨询干预措施八个双月疗程中使用的主要组成部分和BCTs,该干预措施基于自我决定理论原则,旨在通过满足基本心理需求,使参与者有能力为体育活动开发自我调节资源。为干预促进者和参与者开发了一个工具包和手册。进行了一项可行性研究,以监测实施保真度、可接受性、依从性和参与者的体验(通过焦点小组)。
12名女性(平均年龄55.9±6.7岁)参与了研究。实施监测表明该干预措施是可行的。损耗率为25%。焦点小组讨论表明,每周一次的疗程将提高出勤率,强调了自我监测的帮助作用以及体育活动榜样的重要性,并确定在家安全锻炼的疗程是提高体育活动水平的关键。
本研究旨在通过详细说明所使用的具体BCTs、将其转化为实施策略、为促进者/参与者提供全面资源以及支持基于先前研究的基于理论的干预措施的实施、传播和采用,来加强干预开发中的系统报告。可行性测试表明,该干预措施得到了参与者的良好接受且可行,尽管它可能会从形式调整中受益以提高依从性。
NCT05860621,2023年4月20日注册 - 追溯注册,https://clinicaltrials.gov/study/NCT05860621 。2023年4月21日注册 - 追溯注册,https://doi.org/10.17605/OSF.IO/ZAQ_{9}N 。UMIN000050945,2023年4月27日注册 - 追溯注册,https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058070 。