A Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE): Protocol for a randomised controlled feasibility trial

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-04-21 DOI:10.1016/j.cct.2025.107923

Neil Kearney , Deirdre Connolly , Katayoun Bahramian , Grainne Sheill , Kelly Coghlan-Lynch , Jacintha O'Sullivan , Niamh Coleman , Ciara O'Hanlon Brown , David Gallagher , Catherine O'Gorman , Catherine O'Brien , Antonia Tierney , Kate Rankin , Linda O'Neill , Emer Guinan

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引用次数: 0

Abstract

Background

Exercise is an important tool which has been shown to help patients manage many of the side effects of their cancer treatment, reduce toxicities, and improve prognosis. The benefits of exercise have been well documented, however, performing regular exercise during treatment remains a challenge for most patients. The Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE) is an exercise programme that has been co-designed by healthcare professionals and people with a personal lived experience of chemotherapy. The primary aim of this study is to examine the feasibility of delivering the FIERCE programme for cancer patients during chemotherapy.

Methods

The FIERCE study is a randomised controlled feasibility trial which will include 50 participants who are scheduled to receive chemotherapy for the treatment of breast, colorectal, or ovarian cancer. Participants will be randomly allocated to Group 1: FIERCE programme, or Group 2: Self-managed pedometer programme in a 2:1 ratio. Participants will be enrolled in the study for the duration of their chemotherapy treatment. The primary outcome of feasibility will be measured using a mixed-methods approach. Secondary outcomes of cardiorespiratory fitness, muscular strength, skeletal muscle mass, physical function, fatigue, and quality of life will be measured at baseline (T0) and post-intervention (T1).

Discussion

The FIERCE feasibility study aims to explore if a flexible, individualised exercise programme will support individuals to be active during chemotherapy treatment. If proven to be feasible, a large-scale randomised controlled trial will be undertaken focusing on the efficacy of the FIERCE programme on different health outcomes.

Trial Registration

The study is registered with ClinicalTrials.gov, registration number: NCT06280885.

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化疗期间癌症患者灵活的个体化运动计划（激烈）：随机对照可行性试验方案

运动是一种重要的工具，已被证明可以帮助患者控制癌症治疗的许多副作用，减少毒性，改善预后。运动的好处已被充分证明，然而，在治疗期间进行定期运动对大多数患者来说仍然是一个挑战。针对化疗期间癌症患者的灵活个性化运动计划（激烈）是一项由医疗保健专业人员和有化疗个人生活经验的人共同设计的运动计划。本研究的主要目的是检查在化疗期间为癌症患者提供凶猛方案的可行性。凶猛研究是一项随机对照可行性试验，将包括50名计划接受化疗治疗乳腺癌、结直肠癌或卵巢癌的参与者。参与者将按2:1的比例随机分配到第一组：激烈计划或第二组：自我管理计步器计划。参与者将在化疗期间被纳入研究。可行性的主要结果将采用混合方法进行测量。在基线（T0）和干预后（T1）测量心肺功能、肌肉力量、骨骼肌质量、身体功能、疲劳和生活质量的次要结局。激烈的可行性研究旨在探讨一个灵活的，个性化的锻炼计划是否能支持个人在化疗期间保持活跃。如果证明可行，将开展一项大规模随机对照试验，重点关注激烈规划对不同健康结果的功效。本研究已在ClinicalTrials.gov注册，注册号：NCT06280885。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.