Gnagnarella Patrizia, Dragà Daniele, Baggi Federica, Simoncini Maria Claudia, Sabbatini Annarita, Mazzocco Ketti, Bassi Fabio Domenico, Pravettoni Gabriella, Maisonneuve Patrick
Division of Epidemiology and Biostatistics, European Institute of Oncology, Via Adamello, 16, 20139, Milan, Italy.
Physiotherapy Unit, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy.
Trials. 2016 Jul 28;17:363. doi: 10.1186/s13063-016-1487-x.
Most women with breast cancer experience a progressive weight gain during and after treatment. Obesity is associated with an increased risk of recurrence, contralateral breast cancer, and death. Physical activity after cancer diagnosis has been reported to have positive effects on body composition and quality of life. We present the protocol of the InForma study, a trial testing the efficacy of an intervention on weight loss (≥5 % of the baseline body weight) in a group of overweight or obese breast cancer survivors.
METHODS/DESIGN: This is a four-arm randomized controlled trial. Patients will receive a 6-month intervention and be followed for a further 18 months. Intervention is designed to improve adherence to a healthy diet and/or to increase physical activity, taking advantage of a wrist-based activity monitor. Participants will be recruited among overweight or obese breast cancer patients treated at the European Institute of Oncology, after completion of eventual adjuvant chemotherapy and/or radiotherapy. It is envisaged that 260 patients will be randomized into four arms: Dietary Intervention; Physical Activity Intervention; Physical Activity and Dietary Intervention; and Less Intensive Intervention. Women will be offered individualized counseling consisting of face-to face discussion and phone calls in addition to group meetings. A motivational interviewing approach will be used to encourage health behavior change. All participants will be given a pedometer device to monitor their physical activity. Participants' dietary intake will be repeatedly assessed using a validated food frequency questionnaire. Participants' quality of life and anxiety will be assessed with the Functional Assessment of Cancer Therapy-Breast and the State-Trait Anxiety Inventory questionnaires. Blood samples will be collected at baseline and follow-up visits to assess lipid and hormone profiles. Body composition will be repeatedly assessed using bioelectrical impedance vector analysis for identifying changes of fat and fat-free mass. Women allocated to the less intensive intervention arm will be considered as the control group.
While there is a rising concern about the role of obesity in cancer recurrence and survival, this trial with its multi-arm design, motivational approach and use of a pedometer device will provide important insights regarding the most effective approach in promoting weight control in breast cancer survivors.
ISRCTN53325751 (registration date: 16 October 2015); ClinicalTrials.gov NCT02622711 (registration date: 2 December 2015).
大多数乳腺癌女性在治疗期间及之后体重会逐渐增加。肥胖与复发、对侧乳腺癌及死亡风险增加相关。据报道，癌症诊断后进行体育活动对身体成分和生活质量有积极影响。我们介绍了InForma研究的方案，该试验旨在测试一项干预措施对一组超重或肥胖乳腺癌幸存者体重减轻（≥基线体重的5%）的疗效。
方法/设计：这是一项四臂随机对照试验。患者将接受为期6个月的干预，并进一步随访18个月。干预旨在利用基于手腕的活动监测器，提高对健康饮食的依从性和/或增加体育活动。参与者将在欧洲肿瘤研究所接受治疗的超重或肥胖乳腺癌患者中招募，在完成最终的辅助化疗和/或放疗之后。预计将有260名患者随机分为四组：饮食干预组；体育活动干预组；体育活动与饮食干预组；以及低强度干预组。除小组会议外，还将为女性提供包括面对面讨论和电话咨询在内的个性化咨询。将采用动机访谈法鼓励健康行为改变。所有参与者将获得一个计步器设备以监测其体育活动。将使用经过验证的食物频率问卷反复评估参与者的饮食摄入量。将使用癌症治疗功能评估-乳腺癌问卷和状态-特质焦虑量表问卷评估参与者的生活质量和焦虑情况。将在基线和随访时采集血样以评估血脂和激素水平。将使用生物电阻抗矢量分析反复评估身体成分，以确定脂肪和去脂体重的变化。分配到低强度干预组的女性将被视为对照组。
虽然人们越来越关注肥胖在癌症复发和生存中的作用，但这项采用多臂设计、动机方法并使用计步器设备的试验，将为促进乳腺癌幸存者体重控制的最有效方法提供重要见解。
ISRCTN53325751（注册日期：2015年10月16日）；ClinicalTrials.gov NCT02622711（注册日期：2015年12月2日）。
