Background/Objectives: Psychological distress is a significant concern among cancer patients, negatively affecting their quality of life and adherence to treatment. The Cancer Patient Empowerment Program (CancerPEP) was developed as a comprehensive, home-based intervention aimed at reducing psychological distress by incorporating physical activity, dietary guidance, and social support. This study aimed to evaluate the feasibility, accrual and attrition rates, safety, and effectiveness of the CancerPEP intervention, with and without the biofeedback device, on psychological distress from baseline to 6 months, specifically focusing on the effects of group randomization and the difference between pre- and post-intervention results. Methods: This single-site, crossover randomized clinical trial included 104 cancer patients who were randomized to receive the CancerPEP intervention, with or without a Heart Rate Variability (HRV) biofeedback monitor. At 6 months, participants who did not receive the device were allowed to use one until the end of the year, while those who did receive the device were followed up to 12 months. Randomization was stratified by the presence or absence of clinically significant psychological distress and metastatic status. Psychological distress was assessed using the Kessler Psychological Distress Scale (K10) at baseline, 6 months, and 12 months. The primary endpoint was the presence of nonspecific psychological distress, as measured by the K10 scale at 6 months from the trial start, based on group randomization. A secondary exploratory analysis assessed psychological distress at baseline, 6 months, and 12 months for both groups, while controlling for group randomization and prognostic covariates. Prognostic covariates included age; comorbidities; time between diagnosis and randomization; treatment modality; relationship status; and use of prescribed medications for anxiety, depression, or both. An exploratory sub-analysis was conducted for the breast cancer subgroup, based on the sample size available after recruitment. The trial is registered at ClinicalTrials.gov (NCT05508412). Results: The provision of the HRV biofeedback monitor in conjunction with the CancerPEP intervention did not significantly affect the primary outcome in either the full sample or the breast cancer subgroup, indicating that the HRV biofeedback provision was not beneficial in this trial. No self-reported or otherwise discovered adverse events at the 6-month mark were observed. About 10% of participants were lost to follow-up in both the early and late HRV monitor provision groups. Participation in the CancerPEP program led to a significant reduction in psychological distress over time. The odds of psychological distress were significantly higher at the start of the trial than at the end of the intervention (aOR = 2.64, 95% CI: 1.53–4.56) or 6 months after the intervention (aOR = 2.94, 95% CI: 1.62–5.30). Similarly, in the breast cancer subgroup, distress was higher at the trial’s start than at 6 months, i.e., after the intervention (aOR = 2.25, 95% CI: 1.24–4.08), or at the end of the trial at 12 months (aOR = 2.73, 95% CI: 1.35–5.52). Conclusions: CancerPEP significantly reduces psychological distress in cancer patients, with consistent improvements noted across various cancer types and stages, including benefits specifically for breast cancer patients. These findings build upon the success of the Prostate Cancer Patient Empowerment Program (PC-PEP), indicating that a similar comprehensive intervention can be advantageous for all cancer patients and may be further tailored to address specific needs. With its holistic approach—encompassing physical, dietary, and psychosocial support—CancerPEP shows promise as a vital component of survivorship care. Ongoing 24-month evaluations will yield critical data on its long-term benefits. Additionally, a randomized trial with a control group (usual care without intervention) for breast cancer patients is currently under way and could potentially guide the integration of CancerPEP into standard oncology care to enhance patient outcomes and quality of life.
**背景/目的：** 心理困扰是癌症患者面临的重要问题，对其生活质量和治疗依从性产生负面影响。癌症患者赋能计划是一项全面的居家干预措施，旨在通过结合体育活动、饮食指导和社会支持来减轻心理困扰。本研究旨在评估CancerPEP干预（无论是否使用生物反馈设备）从基线到6个月的可行性、招募与流失率、安全性及对心理困扰的有效性，特别关注组间随机化的影响以及干预前后结果的差异。 **方法：** 这项单中心、交叉随机临床试验纳入了104名癌症患者，他们被随机分配接受CancerPEP干预，其中部分患者同时使用心率变异性生物反馈监测仪。在6个月时，未获得设备的参与者被允许使用设备直至年底，而已获得设备的参与者则被随访至12个月。随机化根据是否存在临床显著心理困扰以及转移状态进行分层。心理困扰在基线、6个月和12个月时使用凯斯勒心理困扰量表进行评估。主要终点是基于组间随机化，在试验开始后6个月时通过K10量表测量的非特异性心理困扰的存在情况。一项次要探索性分析评估了两组在基线、6个月和12个月时的心理困扰，同时控制了组间随机化和预后协变量。预后协变量包括：年龄、合并症、诊断至随机化的时间间隔、治疗方式、关系状况以及是否使用针对焦虑、抑郁或两者兼有的处方药物。根据招募后获得的样本量，对乳腺癌亚组进行了探索性亚组分析。本试验已在ClinicalTrials.gov注册。 **结果：** 在完整样本或乳腺癌亚组中，提供HRV生物反馈监测仪与CancerPEP干预相结合，并未显著影响主要结局，表明在本试验中提供HRV生物反馈并无额外获益。在6个月时未观察到自我报告或其他方式发现的不良事件。早期和晚期提供HRV监测仪的组别中，均有约10%的参与者失访。参与CancerPEP项目随时间推移显著降低了心理困扰。试验开始时的心理困扰几率显著高于干预结束时（调整后比值比 = 2.64，95% CI：1.53–4.56）或干预后6个月（调整后比值比 = 2.94，95% CI：1.62–5.30）。同样，在乳腺癌亚组中，试验开始时的困扰程度高于6个月（即干预后）（调整后比值比 = 2.25，95% CI：1.24–4.08）或试验结束时的12个月（调整后比值比 = 2.73，95% CI：1.35–5.52）。 **结论：** CancerPEP能显著减轻癌症患者的心理困扰，在不同癌症类型和分期中均观察到一致的改善，包括对乳腺癌患者的特定获益。这些发现建立在"前列腺癌患者赋能计划"成功的基础上，表明类似的综合性干预对所有癌症患者均有益处，并可进一步定制以满足特定需求。凭借其涵盖身体、饮食和心理社会支持的整体方法，CancerPEP有望成为癌症生存护理的重要组成部分。正在进行的24个月评估将提供关于其长期获益的关键数据。此外，一项针对乳腺癌患者、设有对照组（常规护理，无干预）的随机试验目前正在进行中，可能为将CancerPEP整合到标准肿瘤治疗中以改善患者结局和生活质量提供指导。
肿瘤(癌症)患者之家