Background Internet-delivered interventions can provide remarkable opportunities in addressing breast cancer survivors' unmet support care needs, as they present an effective strategy to improve care coordination and provide access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on improving survivors' psychosocial needs using internet-based tools is scarce and its practical implementation is limited. Objectives To study the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, a 10 weeks guided internet-delivered individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive behavioural (CBT) intervention developed to improve mild to moderate anxiety and depression in Breast cancer survivors when compared to treatment as usual (TAU) in a waiting list control group (WLC). Methods A two-arm, parallel, open label, multicentre, waiting list randomized controlled trial will be conducted to investigate the efficacy and cost-effectiveness of INNOVBC. The primary outcomes in this research will be anxiety and depression. Secondary outcomes will include psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality of Life (HRQoL). Ethical approval This study has been reviewed and approved by Comissão Nacional de Proteção de Dados; Instituto Português de Oncologia do Porto Francisco Gentil; Unidade Local de Saúde de Matosinhos, EPE; Centro Hospitalar de São João and Ordem dos Psicólogos ethical committees. Expected results It is anticipated that iNNOVBC will show to be an efficacious and cost-effective program in improving the outcomes of interest in this study, as opposed to a WLC under TAU. The results of this research will be published in accordance with CONSORT-EHEALTH guidelines. Conclusions This study will inform on the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, in improving psychosocial outcomes in breast cancer survivors when compared to TAU in a WLC. Its conclusions will contribute to understand the idiosyncrasies of designing and implementing internet-delivered interventions in breast cancer survivors. Trial Registration code: INNOVBC (NCT03275727).

中文翻译：

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一项指导性互联网提供的个体定制受 ACT 影响的认知行为干预，以改善乳腺癌幸存者的心理社会结果 (iNNOVBC)：研究方案。

背景 互联网提供的干预措施可以为解决乳腺癌幸存者未满足的支持护理需求提供显着的机会，因为它们提出了改善护理协调并提供有效、经济高效和方便的幸存者护理的有效策略。然而，专注于使用基于互联网的工具改善幸存者社会心理需求的研究很少，而且其实际实施也很有限。目标 研究 iNNOVBC 的可接受性、可行性、有效性和成本效益，这是一项为期 10 周的互联网指导、个性化接受和承诺疗法 (ACT) 影响的认知行为 (CBT) 干预措施，旨在改善轻度至中度焦虑和抑郁与等待名单对照组（WLC）中的常规治疗（TAU）相比，乳腺癌幸存者的疗效。方法将进行双臂、平行、开放标签、多中心、等待名单随机对照试验，以研究 INNOVBC 的疗效和成本效益。这项研究的主要结果是焦虑和抑郁。次要结果包括心理灵活性、疲劳、失眠、性功能障碍和健康相关生活质量（HRQoL）。伦理批准 本研究已得到 Comissao Nacional de Proteção de Dados 的审查和批准；弗朗西斯科·让蒂尔港葡萄牙肿瘤研究所；Unidade Local de Saúde de Matosinhos，EPE；Centro Hospitalar de São João 和 Ordem dos Psicólogos 伦理委员会。预期结果 与 TAU 下的 WLC 相比，预计 iNOVBC 将成为改善本研究中感兴趣的结果的有效且具有成本效益的计划。这项研究的结果将根据 CONSORT-EHEALTH 指南发布。结论 与 WLC 中的 TAU 相比，本研究将介绍 iNNOVBC 在改善乳腺癌幸存者心理社会结果方面的可接受性、可行性、功效和成本效益。其结论将有助于了解乳腺癌幸存者设计和实施互联网干预措施的特质。试用注册代码：INNOVBC (NCT03275727)。