Feasibility of an early versus delayed rehabilitation intervention in patients with lung cancer on cancer-related fatigue: a pilot RCT

Sep 23, 2026

Upload by Himbo

Cancer-related fatigue (CRF) decreases physical performance and quality of life (QoL) in lung cancer patients, yet the best timing for rehabilitation during treatment remains uncertain. This pilot randomized controlled trial evaluates feasibility of pulmonary rehabilitation (PR) combining physical exercise and educational sessions for patients receiving cancer therapies. Forty individuals with stage II–III non-small-cell lung cancer undergoing chemo, radiotherapy, or immunotherapy are randomized to early-PR or delayed-PR groups, with CRF, QoL, activity level, and endurance assessed from baseline through 6 months and with survival, CRF, QoL, and activity assessed one year later.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Introduction

Study aims and rationale

Methods

Study design and participants

Intervention: early vs delayed PR

Outcomes and assessment timeline

Clinical trial registration

FUTURE ONCOLOGY 2026, VOL. 22, NO. 2, 147–156 [https://doi.org/10.1080/14796694.2025.2607632](https://doi.org/10.1080/14796694.2025.2607632) CLINICAL TRIAL PROTOCOL Feasibility of an early versus delayed rehabilitation intervention in patients with lung cancer on cancer-related fatigue: a pilot RCT Stefania Fugazzaroa, Carlotta Maininia, Alessia Pecoraria, Monica Dentia, Maria Beatrice Galavottia, Monica Messoria, Stefania Costib,c, Patrizia Ciammellad, Francesco Falcoe, Francesca Zanellif, Silvio Cavutog and Barbara Bressib aPhysical Medicine and Rehabilitation Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy; bResearch & EBP Unit, Health Professions Department, Azienda USL-IRCCS Di Reggio Emilia, Reggio Emilia, Italy; cDepartment of Surgery, Medicine, Dentistry and Morphological Sciences, University of Modena and Reggio Emilia, Modena, Italy; dRadiation Oncology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy; ePneumology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy; fMedical Oncology, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy; gClinical Trial Center-Statistics Unit, SOC Infrastructure, Research and Statistics, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy ABSTRACT Background: Cancer-related fatigue (CRF) reduces physical performance and quality of life (QoL). Some authors suggest including moderate-intensity physical exercise to manage CRF; however, the optimal timing to offer rehabilitation remains unclear. The primary aim is to investigate the feasibility of a pulmonary rehabilitation (PR) program, including physical exercise and educational sessions, for lung cancer patients undergoing cancer treatments; secondary objectives are to investigate its effect on CRF, physical performance, and QoL. Methods: This randomized controlled trial enrolls 40 patients with stage II or III non-small-cell lung cancer undergoing chemotherapy, radiotherapy, or immunotherapy. Patients are randomly assigned to one of two groups: Group A (early-PR) begins PR after enrollment, at the beginning of non-surgical therapies, while Group B (delayed-PR) begins PR for 3 months after enrollment. The PR program consists of two education sessions focused on CRF management and eight supervised exercise sessions, including aerobic, strengthening, stretching, and breathing exercises, combined with home exercises. CRF, QoL, activity level, and endurance are assessed at the baseline (T0) and at 3 and 6 months (T1–T2). One year after T0, survival is assessed along with the CRF, QoL, and activity level (T3). Feasibility will be assessed at 3 and 6 months. Clinical Trial [Registration:](Registration: www.clinicaltrials.gov)[ www.clinicaltrials.gov](Registration: www.clinicaltrials.gov) identifier is NCT06051136. PLAIN LANGUAGE SUMMARY What is this article about? Many patients with lung cancer experience severe exhaustion (cancer-related fatigue, CRF), which makes it difficult to perform daily activities and lowers their quality of life. Physical exercise is an effective way to manage this fatigue, but it is not yet clear what is the best time to begin a rehabilitation program during cancer treatment. This study investigates whether a pulmonary rehabilitation (PR) program, which includes physical exercise and practical advice, is feasible and safe to implement for lung cancer patients undergoing treatment. What are the expected results of this study? This clinical trial involves 40 patients with non-small-cell lung cancer receiving anticancer therapies. Patients are divided into two groups: one starts rehabilitation immediately, while the other starts 3 months later. The program consists of eight supervised exercise sessions (aerobic, strength, breathing exercises) and two informational sessions focused on managing fatigue. We expect to demonstrate that the program is feasible (i.e. patients can complete it) and that by comparing the two groups, we will identify whi

FAQs

What is the main purpose of this pilot RCT?

To investigate the feasibility of a pulmonary rehabilitation program for lung cancer patients undergoing cancer treatments. The program includes physical exercise and educational sessions.

How are participants allocated to the early and delayed rehabilitation groups?

Forty stage II–III non-small-cell lung cancer patients are randomized to Group A (early-PR) starting PR after enrollment and at the beginning of non-surgical therapies, or Group B (delayed-PR) starting PR 3 months after enrollment.

What outcomes are measured and at what time points?

CRF, QoL, activity level, and endurance are assessed at baseline (T0) and at 3 and 6 months (T1–T2). One year after T0, survival is assessed along with CRF, QoL, and activity level.

Sep 23, 2026

Upload by Himbo