Division of Gastroenterology, Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Republic of Korea.
Division of Gastroenterology, Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Republic of Korea.
JMIR Mhealth Uhealth. 2021 Aug 31;9(8):e21088. doi: 10.2196/21088.
Approximately 80% of pancreatic ductal adenocarcinoma (PDAC) patients suffer from anorexia, weight loss, and asthenia. Most PDAC patients receive chemotherapy, which often worsens their nutritional status owing to the adverse effects of chemotherapy. Malnutrition of PDAC patients is known to be associated with poor prognosis; therefore, nutritional management during chemotherapy is a key factor influencing the outcome of the treatment. Mobile apps have the potential to provide readily accessible nutritional support for patients with PDAC.
We aimed to evaluate the efficacy of a mobile app-based program, Noom, in patients receiving chemotherapy for PDAC.
We prospectively enrolled 40 patients who were newly diagnosed with unresectable PDAC from a single university-affiliated hospital in South Korea, and randomly assigned them into a Noom user group (n=20) and a non-Noom user group (n=20). The 12-week in-app interventions included meal and physical activity logging as well as nutritional education feedback from dietitians. The non-Noom user group did not receive any nutrition intervention. The primary outcomes were the changes in the nutritional status and quality of life (QoL) from the baseline to 12 weeks. The secondary outcomes included the changes in the skeletal muscle index (SMI) from the baseline to 12 weeks. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Patient-Generated Subjective Global Assessment (PG-SGA) were used as paper questionnaires to assess the QoL and nutritional status of the patients. Intention-to-treat and per-protocol analyses were conducted. Regarding the study data collection time points, we assessed the nutritional status and QoL at the baseline (T0), and at 4 (T1), 8 (T2), and 12 (T3) weeks. Abdominal computed tomography (CT) imaging was conducted at the baseline and after 8 weeks for tumor response and SMI evaluation. The skeletal muscle area (cm) was calculated using routine CT images. The cross-sectional areas (cm) of the L3 skeletal muscles were analyzed.
Between February 2017 and January 2018, 48 patients were assessed for eligibility. Totally 40 patients with pancreatic cancer were included by random allocation. Only 17 participants in the Noom user group and 16 in the non-Noom user group completed all follow-ups. All the study participants showed a significant improvement in the nutritional status according to the PG-SGA score regardless of Noom app usage. Noom users showed statistically significant improvements on the global health status (GHS) and QoL scales compared to non-Noom users, based on the EORTC QLQ (P=.004). The SMI decreased in both groups during chemotherapy (Noom users, 49.08±12.27 cm/m to 46.08±10.55 cm/m; non-Noom users, 50.60±9.05 cm/m to 42.97±8.12 cm/m). The decrement was higher in the non-Noom user group than in the Noom user group, but it was not statistically significant (-13.96% vs. -3.27%; P=.11).
This pilot study demonstrates that a mobile app-based approach is beneficial for nutritional and psychological support for PDAC patients receiving chemotherapy.
ClinicalTrials.gov NCT04109495; https://clinicaltrials.gov/ct2/show/NCT04109495.
大约 80%的胰腺导管腺癌 (PDAC) 患者患有厌食、体重减轻和乏力。大多数 PDAC 患者接受化疗，由于化疗的副作用，往往会使他们的营养状况恶化。PDAC 患者的营养不良与预后不良有关；因此，化疗期间的营养管理是影响治疗结果的关键因素。移动应用程序有可能为 PDAC 患者提供易于获得的营养支持。
我们旨在评估基于移动应用程序的 Noom 在接受 PDAC 化疗的患者中的疗效。
我们前瞻性地招募了 40 名来自韩国一所大学附属医院的新诊断为不可切除 PDAC 的患者，并将他们随机分配到 Noom 用户组（n=20）和非 Noom 用户组（n=20）。12 周的应用程序干预包括膳食和体力活动记录以及营养师提供的营养教育反馈。非 Noom 用户组未接受任何营养干预。主要结局是从基线到 12 周时营养状况和生活质量（QoL）的变化。次要结局包括从基线到 12 周时骨骼肌指数（SMI）的变化。欧洲癌症研究与治疗组织（EORTC）生活质量核心问卷（QLQ-C30）和患者生成的主观整体评估（PG-SGA）被用作纸质问卷来评估患者的 QoL 和营养状况。采用意向治疗和方案分析。关于研究数据收集时间点，我们在基线（T0）、4 周（T1）、8 周（T2）和 12 周（T3）时评估了营养状况和 QoL。在基线和 8 周时进行腹部计算机断层扫描（CT）成像以评估肿瘤反应和 SMI 评估。使用常规 CT 图像计算骨骼肌面积（cm）。分析 L3 骨骼肌的横截面积（cm）。
2017 年 2 月至 2018 年 1 月期间，对 48 名患者进行了资格评估。共有 48 名胰腺癌患者通过随机分配被纳入研究。只有 17 名 Noom 用户组和 16 名非 Noom 用户组的参与者完成了所有随访。所有研究参与者根据 PG-SGA 评分均显示出营养状况的显著改善，无论是否使用 Noom 应用程序。与非 Noom 用户相比，Noom 用户在全球健康状况（GHS）和 QoL 量表上的改善具有统计学意义（P=.004）。在化疗期间，两组的 SMI 均下降（Noom 用户，49.08±12.27 cm/m 至 46.08±10.55 cm/m；非 Noom 用户，50.60±9.05 cm/m 至 42.97±8.12 cm/m）。非 Noom 用户组的下降幅度高于 Noom 用户组，但无统计学意义（-13.96%对-3.27%；P=.11）。
这项初步研究表明，基于移动应用程序的方法对接受化疗的 PDAC 患者的营养和心理支持是有益的。
ClinicalTrials.gov NCT04109495；https://clinicaltrials.gov/ct2/show/NCT04109495。
