Mixed Cancer
Conditions
Brief summary
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).
Interventions
OTHERPhysical exercise
The patients can choose between three modality of EX: 1. 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. 2. Personal training program: a personalized activity is proposed. Patients are followed individually in a gym contest by a qualified kinesiologist. 3. 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.
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The CHOiCE includes different substudies, with different study designs, i.e., RCT, single arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants with an adverse event | Change from baseline to 12 weeks | Adverse events will categorize according to the Common Terminology Criteria for Adverse Events (version 5.0) |
| The eligibility rate | At 12 weeks | The number of patients considered eligible dividing the number of subjects who meet inclusion criteria |
| The recruitment rate | At 12 weeks | The number of patients randomized dividing the number of subjects considered eligible |
| The adherence to exercise protocol | At 12 weeks | Measured by the total number of exercise sessions attended |
| The dropouts rate | At 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index | Change from baseline antrhopometric values at 3 months | Calculated from weight and height |
| Waist-hip ratio | Change from baseline antrhopometric values at 3 months | Calculated usign the waist and hip circumferences |
| Cardiorespiratory fitness | Change from baseline cardiorespiratory fitness at 3 months | Using the Six minutes walking test |
| Quality of life (QoL) | Change from baseline quality of life at 3 months | 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) |
| Physical activity level | Change from baseline physical activity level at 3 months | 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. |
| Enjoyment | Change from baseline enjoyment at 3 months | Using the Physical Activity Enjoyment Scale (PACES), ranging from 0 (no enjoyment) to 75 (max enjoyment) |
| Upper limb muscle strength | Change from baseline muscle strength at 3 months | Using the Handgrip strength test |
| Lower limb muscle strength | Change from baseline muscle strength at 3 months | Using the Isometric Leg Press strength test |
| Upper limb flexibility | Change from baseline flexibility at 3 months | Using the Back Scratch test |
| Lower limb flexibility | Change from baseline flexibility at 3 months | Using the Sit and Reach test |
Countries
Italy
Outcome results
None listed