Jebanesan Nirusha, Alibhai Shabbir M H, Santa Mina Daniel, Jones Jennifer, Legacy Nicholas, Freeman Laura, Smith Ainslee, Cobbing Saul, Vadali Neera, Lo Shiuhang, Godhwani Kian, Nasiri Ferozah, Antonio Maryjo, Stephens Douglas, Pitters Eric, Bennie Fay, Stephens Anne, Papadakos Janet, Cerullo Linda, Zjadewicz Margaret, Jang Raymond, Eng Lawson, Krzyzanowska Monika, Matthew Andrew, Durbano Sara, Mehta Rajin, Menjak Ines, Emmenegger Urban, Sattar Schroder, Sun Virginia, Ladham Katherina, Puts Martine
Lawrence Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.
Department of Medicine and Institute of Health Policy, Management, and Evaluation, University Health Network and University of Toronto, Toronto, Ontario, Canada.
J Geriatr Oncol. 2025 Apr;16(3):102194. doi: 10.1016/j.jgo.2025.102194. Epub 2025 Feb 5.
Frail older adults receiving cancer treatment are at heightened risk of adverse outcomes. Despite the known benefits of exercise during cancer treatment to improve well-being, few exercise studies focus on frail older adults receiving cancer treatment and their support person. Geriatric assessment (GA) is often recommended prior to the start of treatment for frail adults with cancer, but combining the GA with a planned exercise regimen remains unexplored. This study aims to determine the feasibility and acceptability of implementing geriatric assessment and management (GAM) in combination with virtual chair-based exercise (CBE) and health education for frail older adults with cancer and their support persons.
This phase 2 randomized controlled trial will include patients aged 70 years and above with a lung, gastrointestinal, or genitourinary cancer referred for first- or second-line chemotherapy, immunotherapy, or targeted therapy. Patients must be frail (≥3 on the Vulnerable Elders Survey), sedentary on the Godin Leisure Time Activity Questionnaire (<90 min of moderate/intense activity per week), have English proficiency with ability to consent, a physician-estimated life expectancy of at least six months, and deemed safe to exercise. Each older adult will be invited to bring a support person to participate in the study. Patients will be randomized 1:1 to GAM combined with online CBE and health education for 12 weeks or waitlist control. Participating support persons will follow the same intervention group. Primary endpoints for feasibility and acceptability will be recruitment rate, retention, adherence, and data collection. Outcome measures include physical activity, function, fatigability, quality of life, treatment toxicity, and unplanned hospital visits. Outcome measures will be used to obtain estimates of the effect size and feasibility analysis needed for designing a phase 3 study. The study will take place at two hospitals in Toronto, Canada.
This study will investigate the feasibility, acceptability, and obtain preliminary estimates of the outcomes of GAM plus CBE and health education in preventing functional decline and improving quality of life in frail older adults receiving cancer treatment and their support persons. The results will help to design a definitive phase 3 randomized controlled trial.
The trial is registered at ClinicalTrials.gov (Registration Number: NCT05509751).
接受癌症治疗的体弱老年人出现不良后果的风险更高。尽管已知在癌症治疗期间进行锻炼对改善健康有益，但很少有锻炼研究关注接受癌症治疗的体弱老年人及其支持人员。对于体弱的癌症成年患者，通常建议在治疗开始前进行老年综合评估（GA），但将GA与有计划的锻炼方案相结合的情况仍未得到探索。本研究旨在确定对患有癌症的体弱老年人及其支持人员实施老年综合评估与管理（GAM），并结合虚拟椅上运动（CBE）和健康教育的可行性和可接受性。
这项2期随机对照试验将纳入年龄在70岁及以上、因一线或二线化疗、免疫治疗或靶向治疗而转诊的肺癌、胃肠道癌或泌尿生殖系统癌症患者。患者必须体弱（在脆弱老年人调查中得分≥3），根据戈丁休闲时间活动问卷显示久坐不动（每周中度/剧烈活动时间<90分钟），具备英语能力且能够签署知情同意书，医生估计预期寿命至少为6个月，并且被认为运动安全。每位老年人将被邀请携带一名支持人员参与研究。患者将按1:1随机分为接受GAM联合在线CBE和健康教育12周组或等待名单对照组。参与的支持人员将跟随相同的干预组。可行性和可接受性的主要终点将是招募率、保留率、依从性和数据收集。结果指标包括身体活动、功能、疲劳性、生活质量、治疗毒性和非计划住院次数。结果指标将用于获得设计3期研究所需的效应大小估计值和可行性分析。该研究将在加拿大多伦多的两家医院进行。
本研究将调查GAM加CBE和健康教育在预防接受癌症治疗的体弱老年人及其支持人员功能衰退和改善生活质量方面的可行性、可接受性，并获得结果的初步估计值。研究结果将有助于设计一项确定性的3期随机对照试验。
该试验已在ClinicalTrials.gov注册（注册号：NCT05509751）。
