"CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise

Not Applicable

Active, not recruiting

• Conditions: Mixed Cancer
• Interventions: Other: Physical exercise

• Registration Number: NCT04226508
• Lead Sponsor: Universita di Verona

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Primary Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical exercise	Physical exercise	-

Primary Outcome Measures

Name	Time	Method
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 recruitment rate	At 12 weeks	The number of patients randomized dividing the number of subjects considered eligible
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.
The eligibility rate	At 12 weeks	The number of patients considered eligible dividing the number of subjects who meet inclusion criteria
The adherence to exercise protocol	At 12 weeks	Measured by the total number of exercise sessions attended

Secondary Outcome Measures

Name	Time	Method
Cardiorespiratory fitness	Change from baseline cardiorespiratory fitness at 3 months	Using the Six minutes walking test
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
Upper limb flexibility	Change from baseline flexibility at 3 months	Using the Back Scratch test
Upper limb muscle strength	Change from baseline muscle strength at 3 months	Using the Handgrip strength test
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)
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)
Lower limb muscle strength	Change from baseline muscle strength at 3 months	Using the Isometric Leg Press strength test
Lower limb flexibility	Change from baseline flexibility at 3 months	Using the Sit and Reach test

Trial Locations

Locations (2)

University of Verona; 🇮🇹 Verona, Italy

Italian League for Fight Cancer; 🇮🇹 Biella, Turin, Italy