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The "CHOICE!" study is an exercise program following the recommendation of the American College of Sports Science for cancer patients. The aims of the intervention are to test the safety and feasibility of a structured program, letting patients choose the modality of delivery. Secondary endpoints include exercise health-related skills and quality of life. The program considers the preferences of exercise of cancer survivors, giving the possibility to choose the exercise modality (autonomous, with a personal trainer or group class). This program will be tested in different cancer populations with different study designs based on different patients cohort (i.e., RCT or single-arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Physical exercise | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Other | The patients can choose between three modality of EX:
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with an adverse event | Adverse events will categorize according to the Common Terminology Criteria for Adverse Events (version 5.0) | Change from baseline to 12 weeks |
| The eligibility rate | The number of patients considered eligible dividing the number of subjects who meet inclusion criteria | At 12 weeks |
| The recruitment rate | The number of patients randomized dividing the number of subjects considered eligible | At 12 weeks |
| The adherence to exercise protocol | Measured by the total number of exercise sessions attended | At 12 weeks |
| The dropouts rate | Defined as a participant who leaves the study for any reason prior to completing the 12-week (24 session) exercise program. All reasons for drop out will be reported. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | Using the Six minutes walking test | Change from baseline cardiorespiratory fitness at 3 months |
| Upper limb muscle strength | Using the Handgrip strength test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Lanza | Universita di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Italian League for Fight Cancer | Biella | Turin | 13900 | Italy | ||
| University of Verona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42015889 | Derived | Avancini A, Borsati A, Adamoli G, Toniolo L, Ciurnelli C, Trevisan A, Belluomini L, Trestini I, Tregnago D, Sposito M, Insolda J, Manduca S, Auriemma A, Fiorio E, Milella M, Lanza M, Schena F, Pilotto S. Real-world feasibility and effectiveness of a personalized exercise program during cancer treatment: results from the CHOiCE prospective study. Oncologist. 2026 May 8;31(6):oyag153. doi: 10.1093/oncolo/oyag153. | |
| 38206849 |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The CHOiCE includes different substudies, with different study designs, i.e., RCT, single arm.
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| Change from baseline muscle strength at 3 months |
| Lower limb muscle strength | Using the Isometric Leg Press strength test | Change from baseline muscle strength at 3 months |
| Upper limb flexibility | Using the Back Scratch test | Change from baseline flexibility at 3 months |
| Lower limb flexibility | Using the Sit and Reach test | Change from baseline flexibility at 3 months |
| Body mass index | Calculated from weight and height | Change from baseline antrhopometric values at 3 months |
| Waist-hip ratio | Calculated usign the waist and hip circumferences | Change from baseline antrhopometric values at 3 months |
| Enjoyment | Using the Physical Activity Enjoyment Scale (PACES), ranging from 0 (no enjoyment) to 75 (max enjoyment) | Change from baseline enjoyment at 3 months |
| Quality of life (QoL) | Using European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ C-30), ranging from 0 (lowest QoL) to 100 (highest QoL) | Change from baseline quality of life at 3 months |
| Physical activity level | Using the Godin's Leisure Time Exercise Questionnaire (GLTEQ). GLTEQ inquires about frequency of vigorous, moderate and mild intensity EX as defined by Godin. Subsequently, each frequency is multiplied by its correspondent metabolic equivalent of the task (MET), i.e. vigorous*9; moderate*5; mild*3. A Leisure Score Index (LSI) was calculated, using the sum of vigorous and moderate components. Based on LSI patients were then classified as active (if LSIā„ 24) and insufficiently active (if LSI<24) according to the American College of Sport Medicine Physical Activity Guidelines. | Change from baseline physical activity level at 3 months |
| Verona |
| 37131 |
| Italy |
| Derived |
| Avancini A, Borsati A, Baldo E, Ciurnelli C, Trestini I, Tregnago D, Belluomini L, Sposito M, Insolda J, Auriemma A, Fiorio E, Piacentini M, Schena F, Milella M, Pilotto S. A Feasibility Study Investigating an Exercise Program in Metastatic Cancer Based on the Patient-Preferred Delivery Mode. Oncologist. 2024 Jun 3;29(6):e828-e836. doi: 10.1093/oncolo/oyae002. |