Ogomori Kelsey, Broering Jeanette, Rogine Camille, Kin Cindy, Chang George J, Finlayson Emily
University of California San Francisco School of Medicine, San Francisco, California, USA
Surgery, University of California San Francisco, San Francisco, California, USA.
BMJ Open. 2025 Feb 18;15(2):e088001. doi: 10.1136/bmjopen-2024-088001.
Colorectal cancer is a leading cause of cancer mortality in the USA and occurs most frequently in older adults. These patients are at increased risk of adverse outcomes following major cancer surgery. While prehabilitation has been shown to mitigate this risk, multiple barriers to implementation remain. Our team created a digital tool co-designed with older adults that employs an algorithm to assess patient-specific geriatric vulnerabilities and generate personalised prehabilitation programmes before surgery.
We have designed a multisite, unblinded randomised trial to be completed at three high-volume academic cancer centres located in California or Texas. Our study population is individuals aged 65 and older with planned colorectal cancer resection who are proficient in English and have home internet access. We aim to enroll 132 patients who will be randomised in a 2:1 ratio to receive the intervention (assistance from a home health coach and access to the web application (web app)) or control (usual care with written prehabilitation materials). Our primary outcome is patient engagement with prehabilitation activities.
A properly executed, written, informed consent will be obtained from each subject prior to entering the subject into the trial. Information will be given in both oral and written form, and subjects may withdraw at any time from the study without effect on their medical care. The protocol and consent form have been approved by the Institutional Review Board (IRB) of each participating centre. We anticipate publication of results in a peer-reviewed journal.
NCT05520866.
结直肠癌是美国癌症死亡的主要原因，在老年人中最为常见。这些患者在接受重大癌症手术后出现不良结局的风险增加。虽然术前康复已被证明可降低这种风险，但实施过程中仍存在多重障碍。我们的团队创建了一种与老年人共同设计的数字工具，该工具采用一种算法来评估患者特定的老年脆弱性，并在手术前生成个性化的术前康复计划。
我们设计了一项多中心、非盲随机试验，将在位于加利福尼亚州或得克萨斯州的三个大型学术癌症中心完成。我们的研究对象是年龄在65岁及以上、计划进行结直肠癌切除术、精通英语且家中可上网的个体。我们的目标是招募132名患者，他们将以2:1的比例随机分组，接受干预措施（家庭健康教练的协助以及使用网络应用程序（网络应用））或对照措施（提供书面术前康复材料的常规护理）。我们的主要结局是患者参与术前康复活动的情况。
在将每位受试者纳入试验之前，将获得其妥善签署的书面知情同意书。信息将以口头和书面形式提供，受试者可随时退出研究，且这不会影响他们的医疗护理。该方案和同意书已获得每个参与中心的机构审查委员会（IRB）的批准。我们预计将在同行评审期刊上发表研究结果。
NCT05520866。
