Clinical trial NCT05497544: ORE - 30 Seconds (Oncologists Recommend Exercise in 30 Secs)
Official title: A Randomized Controlled Trial to Evaluate the Impact of Oncologists 'Exercise Recommendation on the Exercise Levels in Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exercise level
timeFrame: Change from baseline to 4 weeks
Secondary outcomes:
measure: Sedentary behavior
timeFrame: Change from baseline to 4 weeks
measure: Quality of life
timeFrame: Change from baseline to 4 weeks
Other outcomes:
measure: Overall survival
timeFrame: Change from baseline to12 months
measure: Progression free survival
timeFrame: Change from baseline to 12 months
measure: Treatment-related side effects
timeFrame: Change from baseline to 12 months
measure: Exercise level
timeFrame: Change from baseline to 8 weeks
measure: Sedentary behavior
timeFrame: Change from baseline to 8 weeks
measure: Quality of life
timeFrame: Change from baseline to 8 weeks
Locations:
city: Verona
country: Italy
facility: University of Verona
Study officials:
References: