英格兰北部妇女的饮食和活动-乳腺癌(NEWDAY-ABC)干预后诊断为早期雌激素阳性,her2阴性乳腺癌的妇女:一项随机对照可行性研究。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
C Wilson, K Pickering, S Wane, J Cohen, C Huang, M Northgraves, H Crank, A Anderson, H Cain, R Copeland, J Gray, J Hargreaves, R J Q McNally, J M Saxton
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引用次数: 0

摘要

背景:体重过重与乳腺癌死亡率增高有关。本研究评估了在雌激素受体阳性、人表皮生长因子受体2阴性的早期乳腺癌患者中,联合设计的减肥干预(NEWDAY-ABC)与标准治疗的可行性。方法:采用双臂、平行组、随机对照可行性研究。21例完成初级治疗(不包括内分泌治疗)3年内的ER + ve、HER2-ve I-III期乳腺癌患者,从两个英国国家卫生服务乳腺护理单位招募,随机(2:1)分为干预加标准治疗组或单独标准治疗组。干预是与患者共同设计的,包括由训练有素的生活方式顾问和营养师通过远程电话会议远程提供的以小组为基础的支持和技能研讨会。可行性结果包括招募率、数据质量、干预的可接受性和依从性。探索性临床结果包括体重减轻、人体测量、饮食改变、身体活动和患者报告的结果。结果:21名妇女同意研究,1名妇女在随机化之前退出,剩下13名干预组和7名标准护理对照组,其中11名参与者随访6个月。干预疗程的总出勤率为79.6%(74/93疗程完成)。体重(全动力随机对照试验的候选主要结局)在干预组从基线到6个月减少了3.3 kg,而标准护理对照组体重减少了1.1 kg。此外,欧洲癌症研究和治疗组织生活质量问卷-核心30 (EORTC-QLQ30)乳房模块症状量表在干预组中仅改善了乳房和手臂症状,并伴有身体活动和饮食行为的积极变化。结论:NEWDAY-ABC干预是可行的,并且在早期乳腺癌妇女的体重减轻和其他重要健康结局方面显示出初步的有效性证据。干预与标准治疗的临床和成本效益现在需要通过充分有力的临床试验进行强有力的评估。试验注册号:ISRCTN15088551,注册日期为2020年2月3日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

North of England Women's Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomised controlled feasibility study.

North of England Women's Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomised controlled feasibility study.

North of England Women's Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomised controlled feasibility study.

North of England Women's Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomised controlled feasibility study.

North of England Women's Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomised controlled feasibility study.

North of England Women's Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomised controlled feasibility study.

North of England Women's Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomised controlled feasibility study.

Background: Excess body weight is associated with higher breast cancer mortality rate. This study assessed the feasibility of a co-designed weight loss intervention (NEWDAY-ABC) versus standard care in early-stage oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients.

Methods: This was a two-arm, parallel group, randomised controlled feasibility study. Twenty-one ER + ve, HER2-ve stages I-III breast cancer patients, within 3 years of completing primary treatment (excluding endocrine therapy), were recruited from two UK National Health Service Breast Care Units and randomised (2:1) to intervention plus standard care or standard care alone. The intervention was co-designed with patients and comprised small group-based Support & Skills workshops delivered remotely via teleconference by trained lifestyle advisors and dieticians. Feasibility outcomes included recruitment rate, data quality, intervention acceptability and adherence. Exploratory clinical outcomes included weight loss, anthropometric measures, dietary change, physical activity and patient-reported outcomes.

Results: Twenty-one women consented to the study, and 1 withdrew prior to randomisation, leaving 13 in the intervention group and 7 standard care controls, with 11 participants being followed up for 6 months. The overall attendance rate for intervention sessions was 79.6% (74/93 sessions completed). Body weight (candidate primary outcome for a fully powered randomised controlled trial) was reduced in the intervention group by 3.3 kg from baseline to 6 months, versus a 1.1 kg loss of body weight in the standard care control group. Furthermore, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ30) breast module symptom scale scores for breast and arm symptoms improved in the intervention arm only, accompanied by positive changes in physical activity and dietary behaviours.

Conclusion: The NEWDAY-ABC intervention is feasible and showed preliminary evidence of efficacy in terms of weight loss and other important health outcomes in women with early-stage breast cancer. The clinical and cost-effectiveness of the intervention versus standard care now needs to be robustly evaluated via an adequately powered clinical trial.

Trial registration number: ISRCTN15088551, registered 3 February 2020.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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