CHOiCE! Choose Health: Oncological Patients Cenetered Exercise

Study Overview
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Brief Summary
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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).

Official Title
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Different Modalities of Exercise for Physical Activity Promotion in Cancer Patients

Conditions
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Mixed Cancer

Intervention / Treatment
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* Other: Physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a confirmed cancer diagnosis; ≥ 8 weeks post-surgical procedure; Medical clearance for participation provided by primary care physician or oncologist; Informed consent signed; Exclusion Criteria: Age < 18 years old; Pregnancy; Inability to ambulate; Contraindication to participation in a regular physical activity program; Inability to understand the instructions for PA and/or Mini Mental State index <24; Serious physical limitation and/or Karnofsky index <50.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The CHOiCE includes different substudies, with different study designs, i.e., RCT, single arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Physical exercise<br> | Other: Physical exercise<br>* The patients can choose between three modality of EX: Autonomous supervised training : a personalized activity is proposed. People choosing this modality have a written material, in which all the exercise, the activity, the frequency, the duration, the intensity are specifically described and reported, to perform the training at home. A training diary and 7 meetings (face to face, or skype or other modality) are proposed for monitoring the intervention. Personal training program: a personalized activity is proposed. Patients are followed individually in a gym contest by a qualified kinesiologist. Group training program: the training is performed in a small group, supervised and monitored by a qualified kinesiologist. The instructor-user ratio is 1:4 - 1:8, depending on the functional conditions and the heterogeneity of the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 LSI≥ 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 |