"CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise (CHOiCE)

Different Modalities of Exercise for Physical Activity Promotion in Cancer Patients

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Mixed Cancer
• Intervention / Treatment: Other: Physical exercise

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37131
    • University of Verona
  • Turin
    • Biella, Turin, Italy, 13900
      • Italian League for Fight Cancer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Physical exercise	Other: Physical exercise; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Massimo Lanza, Universita di Verona

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 33320

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No