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Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer — OVER-CRF  

Lung Cancer Clinical Trial

Official title:
Feasibility of an Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer on Cancer-related Fatigue: a Pilot RCT

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06051136
Study type Interventional
Source Arcispedale Santa Maria Nuova-IRCCS
Contact Stefania Fugazzaro, Dr.
Phone 0522 296163
Email stefania.fugazzaro@ausl.re.it
Status Recruiting
Phase N/A
Start date February 28, 2023
Completion date September 30, 2024
View Details
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