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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started Jul 2022
Typical duration for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 6, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedAugust 11, 2022
August 1, 2022
1.2 years
August 6, 2022
August 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Exercise level
Exercise level will be evaluated with Godin's Shepard Leisure Time Exercise Questionnaire (0-700)
Change from baseline to 4 weeks
Secondary Outcomes (2)
Sedentary behavior
Change from baseline to 4 weeks
Quality of life
Change from baseline to 4 weeks
Other Outcomes (6)
Overall survival
Change from baseline to12 months
Progression free survival
Change from baseline to 12 months
Treatment-related side effects
Change from baseline to 12 months
- +3 more other outcomes
Study Arms (3)
Exercise recommendation group
EXPERIMENTALExercise recommendation plus guidebook group
EXPERIMENTALControl
NO INTERVENTIONInterventions
A verbal exercise recommendation will be provided. This recommendation will be reported also in the hospital resignation letter.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Obvious significant physical or psychological disabilities (e.g., wheelchair, severe anxiety);
- Not able to speak, read or write in Italian;
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Verona
Verona, 37131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-investigator
Study Record Dates
First Submitted
August 6, 2022
First Posted
August 11, 2022
Study Start
July 1, 2022
Primary Completion
September 1, 2023
Study Completion
July 1, 2025
Last Updated
August 11, 2022
Record last verified: 2022-08