Early Versus Delayed Rehabilitation Intervention in Patients With Lung Cancer

NCT06051136 | Active Not Recruiting

• 1 other identifier: OVER-CRF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility - Adherence rate to the outpatient RP sessions

  The number of patients adhering to at least 70% of outpatient RP sessions scheduled for the relative allocation group will be recorded.

  At 3 and 6 months after baseline

Secondary Outcomes (9)

• Recruitment rate

  At baseline

• Dropout rate

  At 3 and 6 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

• Physical performance

  At baseline, at 3 and 6 months after baseline

Study Arms (2)

Early pulmonary rehabilitation (RP)

EXPERIMENTAL

RP immediately after enrollment.

Behavioral: Pulmonary rehabilitation

Delayed pulmonary rehabilitation (RP)

EXPERIMENTAL

RP after 3 months after enrollment.

Behavioral: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation BEHAVIORAL

The RP intervention consists in 8 sessions supervised by the physiotherapist weekly or biweekly and 2 therapeutic education group meetings on the importance of exercise and CRF management, over the 3 months of intervention. The RP comprise exercise program performed autonomously at home. Both the outpatient and the autonomously home-based exercise sessions comprise aerobic, resistance and respiratory exercise. The exercise program is individualized and can be delivered in telerehabilitation.

Delayed pulmonary rehabilitation (RP); Early pulmonary rehabilitation (RP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia

Reggio Emilia, Reggio Emilia, 42123, Italy

Location

Related Publications (1)

• Fugazzaro S, Mainini C, Pecorari A, Denti M, Galavotti MB, Messori M, Costi S, Ciammella P, Falco F, Zanelli F, Cavuto S, Bressi B. Feasibility of an early versus delayed rehabilitation intervention in patients with lung cancer on cancer-related fatigue: a pilot RCT. Future Oncol. 2026 Jan 6:1-10. doi: 10.1080/14796694.2025.2607632. Online ahead of print.

  PMID: 41496492 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stefania Fugazzaro, Dr.

  Azienda USL Reggio Emilia - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single-center, two-arm, open-label pilot RCT.

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 22, 2023
• Study Start: February 28, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 31, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)