Lung CancerORENCT05497544
ORE - 30 Seconds (Oncologists Recommend Exercise in 30 Secs)
A study testing Exercise recommendation group and Exercise recommendation plus guidebook group in people with Lung Cancer, run by Universita di Verona at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Exercise recommendation group and Exercise recommendation plus guidebook group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Obvious significant physical or psychological disabilities (e.g., wheelchair, severe anxiety);
- Not able to speak, read or write in Italian;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Verona
Verona, 37131
Alice Avancini, 3403624264 ext. 39, alice.avancini@univr.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Exercise recommendation group, Exercise recommendation plus guidebook group
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise recommendation groupBehavioural
A verbal exercise recommendation will be provided. This recommendation will be reported also in the hospital resignation letter.
Exercise recommendation plus guidebook groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise recommendation group | Experimental | Not described Receives: Behavioral: Exercise recommendation group |
| Exercise recommendation plus guidebook group | Experimental | Not described Receives: Behavioral: Exercise recommendation plus guidebook group |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise level
Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)
Measured: Change from baseline to 4 weeks
Secondary outcomes (2)
Sedentary behavior
Sedentary behavior will be evaluated with the sedentary Behavior Questionnaire (0-500)
Measured: 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)
Measured: Change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Jul 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Avancini, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497544
- Sponsor's protocol ID
- 26622
- Acronym
- ORE
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Avancini A, Belluomini L, Giannarelli D, Insolda J, Borsati A, Sposito M, Menis J, Lavagnolo P, Tregnago D, Trestini I, Schena F, Milella M, Pilotto S. Impact of the Oncologist's Recommendation on Exercise Levels and Quality of Life in Patients With Lung Cancer: The ORE Randomized Controlled Trial. Cancer Med. 2026 May;15(5):e71857. doi: 10.1002/cam4.71857.
PubMed 42036773
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Impact of Oncologists 'Exercise Recommendation on the Exercise Levels in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05497544
- Acronym / sponsor ID
- ORE / 26622
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise recommendation group | Experimental | Behavioral: Exercise recommendation group |
| Exercise recommendation plus guidebook group | Experimental | Behavioral: Exercise recommendation plus guidebook group |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Obvious significant physical or psychological disabilities (e.g., wheelchair, severe anxiety);
- Not able to speak, read or write in Italian;
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise recommendation groupA verbal exercise recommendation will be provided. This recommendation will be reported also in the hospital resignation letter. | Behavioural | Exercise recommendation group |
| Exercise recommendation plus guidebook groupThis group will receive the exercise (verbal and written) recommendation. Additionally, the oncologist hand the patient a guidebook about exercise, specifically designed for cancer patients. | Behavioural | Exercise recommendation plus guidebook group |
Primary outcome
Exercise level
Time frame: Change from baseline to 4 weeks
Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)
2 secondary outcomes
Sedentary behavior
Time frame: Change from baseline to 4 weeks
Quality of life
Time frame: Change from baseline to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Derived from this study: PubMed 42036773Avancini A, Belluomini L, Giannarelli D, Insolda J, Borsati A, Sposito M, Menis J, Lavagnolo P, Tregnago D, Trestini I, Schena F, Milella M, Pilotto S. Impact of the Oncologist's Recommendation on Exercise Levels and Quality of Life in Patients With Lung Cancer: The ORE Randomized Controlled Trial. Cancer Med. 2026 May;15(5):e71857. doi: 10.1002/cam4.71857.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise recommendation group and Exercise recommendation plus guidebook group in people with Lung Cancer, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Avancini, Ph.D. (3403624264, alice.avancini@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise level (time frame: Change from baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.