ORE - 30 Seconds (Oncologists Recommend Exercise in 30 Secs) (ORE)

A Randomized Controlled Trial to Evaluate the Impact of Oncologists 'Exercise Recommendation on the Exercise Levels in Lung Cancer Patients

The O.R.E. - 30 seconds (Oncologists Recommend Exercise in 30 secs) trial aims to test the impact of oncologist recommendations on physical activity level, in patients with lung cancer.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Exercise recommendation group; Behavioral: Exercise recommendation plus guidebook group

Detailed Description

Lung malignancy still remains the leading cause of cancer incidence and mortality worldwide. Despite the improvement in terms of innovative treatments, lung cancer and related therapies continue to be associated with severe physical, psychological, and social side effects.

In recent years, several studies have investigated the potential role of physical activity (PA) and exercise (EX) as supportive therapy following a lung cancer diagnosis. Several randomized controlled studies provided evidence that EX is safe for lung cancer patients and may enhance several physiologic and psychologic outcomes. During the preoperative period, EX has demonstrated to increase cardiorespiratory fitness (CRF), and muscular strength, to reduce postoperative complications and length of hospital stay. Following surgery and/or during medical treatments, EX has shown to have a potent modulator effect, able to increase the health-related fitness capacities (especially CRF, muscular strength, and body composition), manage some treatment side effects, such as cancer-related fatigue, sleep disorder and anxiety/depression symptoms. In lung cancer settings, health-related fitness capacities, especially CRF, muscular strength and body composition, are resulted to be prognostic factors. For example, Jones et al. prospectively found that each 50 meters improvement in six minutes walking test (for assessing CRF) was associated with a reduction of 13% in the risk of death in patients with metastatic non-small cell lung cancer. Moreover, some preliminary observational data suggest that higher postdiagnosis PA is associated with lower recurrence, and specific and all-cause mortality in breast, colon, and prostate cancers. American Cancer Society and the American College of Sports Medicine recommend that cancer patients should achieve at least 90 min of moderate-intensity aerobic physical activity each week, with strength and flexibility exercises at least two times per week.

Though the EX benefits are remarkable, most lung cancer patients result insufficiently active. Physician counseling has a positive impact on physical activity levels in sedentary adults, and even in the oncological setting can be a crucial key to engaging or improving PA or EX. Lung cancer patients reported that they prefer to receive PA information primarily from oncologists, and this counseling seems effective in improving PA levels. A randomized controlled trial indicated that 30-second oncologist counseling has a modest effect on PA behavior in breast cancer patients. In particular, at five weeks post-consultation, patients that received EX recommendation reported 3.4 metabolic equivalents of the task (MET)-hour of total EX per week (approximately 30 minutes of moderate-intensity) more compared to the usual care group.

To date, limited data support the favorable role of oncologist recommendation, with no research focusing on lung cancer settings. To bridge this gap, we propose the O.R.E. - 30 seconds (Oncologists Recommend Exercise in 30 secs) trial to test the impact of oncologist recommendation on physical activity level.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice Avancini, Ph.D.; Phone Number: 3403624264; Email: alice.avancini@univr.it

Study Locations

• Italy
  • Verona, Italy, 37131
    • Recruiting
    • University of Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed diagnosis of lung cancer (from 0 to 24 months since diagnosis;
• Stage I-IV;
• Age ≥ 18 years;
• ECOG (performance status) ≤ 1;
• Written informed consent signed.

Exclusion Criteria:

• Obvious significant physical or psychological disabilities (e.g., wheelchair, severe anxiety);
• Not able to speak, read or write in Italian;
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Exercise recommendation group	Behavioral: Exercise recommendation group; A verbal exercise recommendation will be provided. This recommendation will be reported also in the hospital resignation letter.
Experimental: Exercise recommendation plus guidebook group	Behavioral: Exercise recommendation plus guidebook group; This group will receive the exercise (verbal and written) recommendation. Additionally, the oncologist hand the patient a guidebook about exercise, specifically designed for cancer patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise level	Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)	Change from baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary behavior	Sedentary behavior will be evaluated with the sedentary Behavior Questionnaire (0-500)	Change from baseline to 4 weeks
Quality of life	Quality of life will be evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (0-100)	Change from baseline to 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival will be assessed through death from any cause.	Change from baseline to12 months
Progression free survival	Progression free survival will be assessed through tumor progression or death from any cause	Change from baseline to 12 months
Treatment-related side effects	Treatment-related side effects will be assessed using the Common Terminology Criteria for Adverse Events	Change from baseline to 12 months
Exercise level	Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)	Change from baseline to 8 weeks
Sedentary behavior	Sedentary behavior will be evaluated with the sedentary Behavior Questionnaire (0-500)	Change from baseline to 8 weeks
Quality of life	Quality of life will be evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (0-100)	Change from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: Universita di Verona

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 26622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No