- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07652502
Physical Exercise During the Cancer Care Pathway (ECOLE)
Background: Physical exercise is proven safe and effective in improving quality of life and reducing treatment-related side effects in oncology. However, patient adherence to international guidelines remains suboptimal. Investigating the knowledge, attitudes, and practices (KAP) regarding physical activity is crucial to identifying unmet educational needs and barriers.
Objective: This multicenter, cross-sectional observational study (ECOLE project) aims to assess KAP levels concerning exercise among cancer patients and explore the correlations between KAP scores and sociodemographic or clinical variables.
Methods: Over a 6-month period, an anonymous online survey (Microsoft Forms) will be administered to adult cancer patients (≥18 years old) at any disease or treatment stage. A minimum sample size of 370 participants is targeted. Statistical analyses will include Descriptive Statistics, Exploratory and Confirmatory Factor Analyses to validate KAP scales, and Multivariable Logistic Regression to identify predictors of adherence (≥150 minutes/week) and perceived barriers or facilitators.
Expected Results: The study will provide a comprehensive overview of physical activity perceptions and behaviors in oncology. These insights will support the design of targeted educational interventions and structured exercise programs, contributing to the development of a novel "Exercise Oncology Specialist" within supportive care teams.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stefano Magno
- Phone Number: +390630157077
- Email: stefano.magno@policlinicogemelli.it
Study Locations
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Paris, France, 92300
- Institut Rafael
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Contact:
- Nathaniel Scher
- Email: nathaniel.scher@gmail.com
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Principal Investigator:
- Nathaniel Scher
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Iași, Romania, 700506
- Universitatea Alexandru Ioa Cuza din Iasi
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Contact:
- Beatrice Abalasei
- Email: beatrice.abalasei@uaic.ro
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Principal Investigator:
- Beatrice Abalasei
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Oncological diagnosis
- Ability to understand the language of the respective country of origin
- Electronic informed consent
Exclusion Criteria:
- Failure to accept the informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physical exercise in cancer patients.
Time Frame: 1 day
|
To evaluate the level of knowledge, attitudes, and practices (KAP) related to physical by administering the study questionnaire.exercise in cancer patients.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
safety of physical exercise oncology
Time Frame: 1 day
|
Determine the level of knowledge regarding the benefits and safety of physical exercise by administering the study questionnaire.
|
1 day
|
|
self-efficacy regarding exercise oncology
Time Frame: 1 day
|
Evaluate attitudes, perceptions, and self-efficacy regarding physical activity by administering the study questionnaire.
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1 day
|
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relationship between exercise oncology and oncological journey
Time Frame: 1 day
|
Analyze the potential relationship between knowledge, attitudes, and the practice of physical exercise
|
1 day
|
|
demographic and clinical variables in exercise oncology
Time Frame: 1 day
|
Explore the role of demographic and clinical variables (e.g., age, sex, tumor type, phase of treatment) by administering the study questionnaire.
|
1 day
|
|
barriers and facilitators to exercise oncology
Time Frame: 1 day
|
Identify potential barriers and facilitators to the practice of physical exercise by administering the study questionnaire.
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1 day
|
|
interest of cancer patients in exercise oncology
Time Frame: 1 day
|
Assess the interest of cancer patients in structured physical exercise programs by administering the study questionnaire.
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stefano Magno, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27191
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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