"CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise

Mixed Cancer Clinical Trial

— CHOiCE  

Official title:

Different Modalities of Exercise for Physical Activity Promotion in Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04226508
• Other study ID #: 33320
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2023
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mixed Cancer

Intervention

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.

Locations

Country	Name	City	State
Italy	Italian League for Fight Cancer	Biella	Turin
Italy	University of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The eligibility rate	The number of patients considered eligible dividing the number of subjects who meet inclusion criteria	At 12 weeks
Primary	The recruitment rate	The number of patients randomized dividing the number of subjects considered eligible	At 12 weeks
Primary	The adherence to exercise protocol	Measured by the total number of exercise sessions attended	At 12 weeks
Primary	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	Cardiorespiratory fitness	Using the Six minutes walking test	Change from baseline cardiorespiratory fitness at 3 months
Secondary	Upper limb muscle strength	Using the Handgrip strength test	Change from baseline muscle strength at 3 months
Secondary	Lower limb muscle strength	Using the Isometric Leg Press strength test	Change from baseline muscle strength at 3 months
Secondary	Upper limb flexibility	Using the Back Scratch test	Change from baseline flexibility at 3 months
Secondary	Lower limb flexibility	Using the Sit and Reach test	Change from baseline flexibility at 3 months
Secondary	Body mass index	Calculated from weight and height	Change from baseline antrhopometric values at 3 months
Secondary	Waist-hip ratio	Calculated usign the waist and hip circumferences	Change from baseline antrhopometric values at 3 months
Secondary	Enjoyment	Using the Physical Activity Enjoyment Scale (PACES), ranging from 0 (no enjoyment) to 75 (max enjoyment)	Change from baseline enjoyment at 3 months
Secondary	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
Secondary	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