改善妇科癌症治疗效果（ACUMEN）：一项随机对照运动试验方案

Enhancing treatment outcomes after gynaecological cancer (ACUMEN): a randomised controlled exercise trial protocol.

作者信息

Chiu Vivian, Boytar Alexander, Cunningham Brent, Skinner Tina, Turner Jane, Anderson Debra, Khan Asaduzzaman, Bailey Tom, Porter-Steele Janine, Young Leonie, Tuffaha Haitham, Perrin Lewis, Garrett Andrea, Goh Jeffrey, Rose Grace, Clifford Briana, Gomersall Sjaan, Korbie Darren, Constantin Nicolas, Li Jackie, McCarthy Alexandra Leigh

机构信息

School of Nursing, Midwifery and Social Work, The University of Queensland, Level 3, Chamberlain Building (35), St Lucia, QLD, 4072, Australia.

Griffith Health Group, Griffith University, Gold Coast, Australia.

出版信息

BMC Cancer. 2025 Jul 21;25(1):1195. doi: 10.1186/s12885-025-14298-3.

DOI:10.1186/s12885-025-14298-3

PMID:40691826

Abstract

BACKGROUND

Treatment for gynaecological cancer often entails challenges that negatively affect quality-of-life. While exercise has been shown to improve physical and psychosocial well-being during cancer recovery, affected women often avoid exercise due to the specific health challenges they face after treatment. The Enhancing treatment outcomes after gynaecological cancer (ACUMEN) program aims to enhance health-related quality of life in this group by promoting lifelong exercise habits.

METHODS

The ACUMEN trial is a single-blind, multi-centre randomised controlled trial that evaluates the impact of a structured exercise intervention on quality of life in women who have completed primary treatment for gynaecological cancer within the last 60 months. A total of 342 participants will be randomly assigned to either usual care or an intervention group. The intervention involves a 12-week personalised exercise program, where participants will complete three 1-h exercise sessions per week. During the first six weeks, participants will receive two supervised sessions with accredited exercise physiologists or physiotherapists and self-manage one session per week. In the following six weeks, this shifts to one supervised session and two self-managed sessions weekly, with goal of fostering sustainable, self-managed exercise habits. Assessments will take place at baseline, Week 12 (end of intervention), and Week 24 (end of maintenance). The primary outcome is health-related quality of life, measured by the Short Form-36. Secondary outcomes include exercise self-efficacy, body composition, symptoms of lymphoedema, physical fitness, biological markers, and habitual physical activity levels. For intervention group participants assigned accredited exercise physiologists or physiotherapists will track attendance, adherence, feasibility, and safety.

DISCUSSION

The ACUMEN trial will evaluate whether a structured exercise program improves health-related quality of life in women recovering from gynaecological cancer treatment. The findings will help determine if the intervention is effective and sustainable, with a simultaneous cost-effectiveness analysis conducted to assess its value for money. Results from this study could inform future exercise-based interventions to enhance cancer recovery.

TRIAL REGISTRATION

Australian New Zealand Clinical Trial Registry (ACTRN12621000050853, registered 19/01/2021).

摘要

背景

妇科癌症的治疗常常带来诸多挑战，对生活质量产生负面影响。虽然运动已被证明在癌症康复期间能改善身体和心理社会健康状况，但患病女性由于治疗后面临的特定健康挑战，往往会回避运动。妇科癌症治疗后改善治疗效果（ACUMEN）项目旨在通过促进终身运动习惯来提高该群体与健康相关的生活质量。

方法

ACUMEN试验是一项单盲、多中心随机对照试验，评估结构化运动干预对在过去60个月内完成妇科癌症初始治疗的女性生活质量的影响。总共342名参与者将被随机分配到常规护理组或干预组。干预包括一个为期12周的个性化运动项目，参与者每周将完成三次1小时的运动课程。在前六周，参与者将接受两次由认可的运动生理学家或物理治疗师指导的课程，并每周自行安排一次课程。在接下来的六周里，转变为每周一次指导课程和两次自行安排的课程，目标是培养可持续的、自主管理的运动习惯。评估将在基线、第12周（干预结束时）和第24周（维持期结束时）进行。主要结局是通过简短健康调查问卷-36（Short Form-36）测量的与健康相关的生活质量。次要结局包括运动自我效能、身体成分、淋巴水肿症状、身体素质、生物标志物和习惯性身体活动水平。对于干预组中分配了认可的运动生理学家或物理治疗师的参与者，他们将跟踪出勤情况、依从性、可行性和安全性。