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

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Exercise recommendation group
Exercise recommendation plus guidebook group
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of VeronaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Exercise recommendation group

Exercise recommendation plus guidebook group

Control

Arm Description

Outcomes

Primary Outcome Measures

Exercise level
Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)

Secondary Outcome Measures

Sedentary behavior
Sedentary behavior will be evaluated with the sedentary Behavior Questionnaire (0-500)
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)

Full Information

First Posted
August 6, 2022
Last Updated
August 9, 2022
Sponsor
Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT05497544
Brief Title
ORE - 30 Seconds (Oncologists Recommend Exercise in 30 Secs)
Acronym
ORE
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise recommendation group
Arm Type
Experimental
Arm Title
Exercise recommendation plus guidebook group
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise recommendation group
Intervention Description
A verbal exercise recommendation will be provided. This recommendation will be reported also in the hospital resignation letter.
Intervention Type
Behavioral
Intervention Name(s)
Exercise recommendation plus guidebook group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise level
Description
Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)
Time Frame
Change from baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Sedentary behavior
Description
Sedentary behavior will be evaluated with the sedentary Behavior Questionnaire (0-500)
Time Frame
Change from baseline to 4 weeks
Title
Quality of life
Description
Quality of life will be evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (0-100)
Time Frame
Change from baseline to 4 weeks
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
Overall survival will be assessed through death from any cause.
Time Frame
Change from baseline to12 months
Title
Progression free survival
Description
Progression free survival will be assessed through tumor progression or death from any cause
Time Frame
Change from baseline to 12 months
Title
Treatment-related side effects
Description
Treatment-related side effects will be assessed using the Common Terminology Criteria for Adverse Events
Time Frame
Change from baseline to 12 months
Title
Exercise level
Description
Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)
Time Frame
Change from baseline to 8 weeks
Title
Sedentary behavior
Description
Sedentary behavior will be evaluated with the sedentary Behavior Questionnaire (0-500)
Time Frame
Change from baseline to 8 weeks
Title
Quality of life
Description
Quality of life will be evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (0-100)
Time Frame
Change from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Avancini, Ph.D.
Phone
3403624264
Email
alice.avancini@univr.it
Facility Information:
Facility Name
University of Verona
City
Verona
ZIP/Postal Code
37131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Avancini
Phone
3403624264
Ext
39
Email
alice.avancini@univr.it

12. IPD Sharing Statement

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

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