Yan Huimin, Gonzalo-Encabo Paola, Wilson Rebekah L, Christopher Cami N, Cannon James D, Kang Dong-Woo, Gardiner John, Perez Michelle, Norris Mary K, Gundersen Daniel, Hayman Laura L, Freedman Rachel A, Rebbeck Timothy R, Shi Ling, Dieli-Conwright Christina M
Department of Exercise and Health Sciences, Manning College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, United States.
Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
Front Oncol. 2024 Sep 16;14:1427046. doi: 10.3389/fonc.2024.1427046. eCollection 2024.
Higher rates of physical inactivity and comorbid conditions are reported in Hispanic/Latinx and Black cancer patients receiving chemotherapy compared to their White counterparts. Despite the beneficial effect of exercise training for cancer patients, rates of participation in exercise oncology clinical trials are low among disadvantaged and racial and ethnic minority groups. Here, we will examine the effect of an exercise intervention using a novel, accessible, and cost-effective home-based exercise approach among Hispanic/Latinx and Black cancer patients receiving chemotherapy on exercise participation and cardiovascular disease risk.
The THRIVE trial is an 8-month prospective, three-arm study of 45 patients who are randomized in a 1:1:1 fashion to a supervised exercise intervention (SUP), unsupervised exercise (UNSUP), or an attention control (AC) group. Eligible patients include those with breast, colorectal, or prostate cancer, who are sedentary, overweight or obese, self-identify as Hispanic/Latinx or Black, and plan to receive chemotherapy. Patients randomized to the SUP group participate in a home-based 16-week periodized aerobic and resistance exercise program performed three days per week, supervised through video conference technology. Patients randomized to the UNSUP group participate in an unsupervised 16-week, telehealth-based, periodized aerobic and resistance exercise program performed three days per week using the same exercise prescription parameters as the SUP group. Patients randomized to the AC group receive a 16-week home-based stretching program. The primary outcome is changes in minutes of physical activity assessed by 7-day accelerometry at post-intervention. Secondary outcomes include cardiovascular risk factors, patient-reported outcomes, and physical function. Outcome measures are tested at baseline, post-intervention at month 4, and after a non-intervention follow-up period at month 8.
The THRIVE trial is the first study to employ a novel and potentially achievable exercise intervention for a minority population receiving chemotherapy. In addition, this study utilizes an intervention approach to investigate the biological and behavioral mechanisms underlying exercise participation in these cancer patients. Results will guide and inform large randomized controlled trials to test the effect of home-based exercise on treatment outcomes and comorbid disease risk in minority patients with cancer undergoing chemotherapy.
https://classic.clinicaltrials.gov/ct2/show/NCT05327452, identifier (NCT#05327452).
据报道，与白人癌症患者相比，接受化疗的西班牙裔/拉丁裔和黑人癌症患者身体活动不足和合并症的发生率更高。尽管运动训练对癌症患者有有益影响，但弱势群体以及种族和少数民族群体参与运动肿瘤学临床试验的比例较低。在此，我们将研究一种新颖、便捷且经济高效的居家运动方法对接受化疗的西班牙裔/拉丁裔和黑人癌症患者运动参与度和心血管疾病风险的影响。
THRIVE试验是一项为期8个月的前瞻性三臂研究，共纳入45名患者，他们以1:1:1的比例随机分为监督运动干预组（SUP）、非监督运动组（UNSUP）或注意力控制组（AC）。符合条件的患者包括患有乳腺癌、结直肠癌或前列腺癌、久坐不动、超重或肥胖、自我认定为西班牙裔/拉丁裔或黑人且计划接受化疗的患者。随机分配到SUP组的患者参加为期16周的居家有氧和抗阻运动计划，每周进行三天，通过视频会议技术进行监督。随机分配到UNSUP组的患者参加一项非监督的为期16周的基于远程医疗的有氧和抗阻运动计划，每周进行三天，使用与SUP组相同的运动处方参数。随机分配到AC组的患者接受为期16周的居家伸展计划。主要结局是干预后通过7天加速度计评估的身体活动分钟数的变化。次要结局包括心血管危险因素、患者报告的结局和身体功能。结局指标在基线、干预后第4个月以及第8个月的非干预随访期进行测试。
THRIVE试验是第一项针对接受化疗的少数族裔人群采用新颖且可能可行的运动干预的研究。此外，本研究采用干预方法来研究这些癌症患者运动参与背后的生物学和行为机制。研究结果将指导并为大型随机对照试验提供信息，以测试居家运动对接受化疗的少数族裔癌症患者治疗结局和合并疾病风险的影响。
https://classic.clinicaltrials.gov/ct2/show/NCT05327452，标识符（NCT#05327452）。
