Feasibility of an Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer on Cancer-related Fatigue: a Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Feasibility - Adherence rate to the outpatient RP sessions
研究概览
简要总结
In Italy, the incidence of lung cancer for the year 2020 has been estimated at about 41.000 new diagnoses. Patients with lung cancer experience debilitating symptoms caused by the disease itself and cancer treatments, such as dyspnea and fatigue, which reduce physical function and quality of life (QoL). It is estimated that 90% of patients undergoing chemotherapy and 57% of patients undergoing lung resection suffer of Cancer-Related Fatigue (CRF).
Previous studies have shown that educational interventions and aerobic and resistance exercise are effective in improving CRF and QoL in patients with lung cancer. However, to date the optimal dose, mode and timing to deliver the intervention during the care pathway for lung cancer patients is unknown. Tolerability and frequency of cancer treatment could be a barrier to adherence to the intervention. Therefore, this study aims to evaluate the feasibility of a rehabilitation intervention aimed at improving CRF with respect to timing of delivery: early vs delayed rehabilitation in lung cancer patients.
详细描述
The primary outcome of the study is to evaluate the feasibility of the experimental pulmonary rehabilitation (RP) program combining the exercise component with the educational component for patients with lung cancer undergoing chemotherapy and/or radiotherapy and/or immunotherapy, delivering RP at different points in the course of their care pathway. The secondary outcome is to evaluate the impact of the intervention on several health outcomes (CRF, physical performance, and QoL) by assessing any differences between early and delayed RP.
The early RP intervention will be delivered in the first three months of cancer treatment, while the same delayed RP intervention will be delivered three months after the start of treatment. Finally, considering the potential beneficial role that exercise on survival of patients with cancer, this study also aims to evaluate this outcome at 12 months after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The randomization will be done online directly from Smarty, the software that will manage the eCRF for collecting of the study data.
Furthermore, outcomes will be assessed blindly by staff involved in the research project who do not directly deliver the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed of stage II and III lung cancer (NSCLC) candidates for anticancer therapies (chemotherapy, radiotherapy, immunotherapy, or combinations thereof), associated or not with surgery. In the last case, patients will be included at least 30 days after surgery.
- •Prognosis ≥ 12 months
- •At least 18 years old
- •Recruited from the pneumology, oncology, radiotherapy, and physical medicine and rehabilitation unit of the Azienda Unità Sanitaria Locale - IRCCS of Reggio Emilia
- •Willing and able to give written informed consent
排除标准
- •Clinical disorders that contraindicate participation in a moderate exercise program (e.g. preexisting severe physical disabilities, major cognitive or sensory deficits, severe psychiatric disorders, language barrier, etc.).
- •NSCLC stage IV
- •Patients who are candidates for surgery alone
- •Patients who are candidates for neoadjuvant therapy
研究组 & 干预措施
Early pulmonary rehabilitation (RP)
RP immediately after enrollment.
干预措施: Pulmonary rehabilitation (Behavioral)
Delayed pulmonary rehabilitation (RP)
RP after 3 months after enrollment.
干预措施: Pulmonary rehabilitation (Behavioral)
结局指标
主要结局
Feasibility - Adherence rate to the outpatient RP sessions
时间窗: At 3 and 6 months after baseline
The number of patients adhering to at least 70% of outpatient RP sessions scheduled for the relative allocation group will be recorded.
次要结局
- Recruitment rate(At baseline)
- Adherence to the exercise home-based sessions(At baseline, at 3 and 6 months after baseline)
- Dropout rate(At 3 and 6 months after baseline)
- Physical performance(At baseline, at 3 and 6 months after baseline)
- Physical activity level(At baseline, at 3, 6, and 12 months after baseline)
- Cancer-related fatigue (CRF)(At baseline, at 3, 6, and 12 months after baseline)
- Quality of life (QoL)(At baseline, at 3, 6, and 12 months after baseline)
- Survival(At 12 months after baseline)
- Adverse events(At 3, 6, and 12 months after baseline)