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

Lung Cancer Clinical Trial

— ORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497544
• Other study ID #: 26622
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2022
• Source: Universita di Verona
• Contact: Alice Avancini, Ph.D.
• Phone: 3403624264
• Email: alice.avancini[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2025
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Exercise recommendation group
A verbal exercise recommendation will be provided. This recommendation will be reported also in the hospital resignation letter.
• 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.

Locations

Country	Name	City	State
Italy	University of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	Overall survival will be assessed through death from any cause.	Change from baseline to12 months
Other	Progression free survival	Progression free survival will be assessed through tumor progression or death from any cause	Change from baseline to 12 months
Other	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
Other	Exercise level	Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)	Change from baseline to 8 weeks
Other	Sedentary behavior	Sedentary behavior will be evaluated with the sedentary Behavior Questionnaire (0-500)	Change from baseline to 8 weeks
Other	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
Primary	Exercise level	Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)	Change from baseline to 4 weeks
Secondary	Sedentary behavior	Sedentary behavior will be evaluated with the sedentary Behavior Questionnaire (0-500)	Change from baseline to 4 weeks
Secondary	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