"CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise

Universita di Verona80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Mixed Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (2)

Italian League for Fight Cancer

Biella, Turin, Italy

University of Verona

Verona, Italy

Outcomes

Primary Outcomes

The number of participants with an adverse event

Adverse events will categorize according to the Common Terminology Criteria for Adverse Events (version 5.0)

Time frame: Change from baseline to 12 weeks

The eligibility rate

The number of patients considered eligible dividing the number of subjects who meet inclusion criteria

Time frame: At 12 weeks

The recruitment rate

The number of patients randomized dividing the number of subjects considered eligible

Time frame: At 12 weeks

The adherence to exercise protocol

Measured by the total number of exercise sessions attended

Time frame: 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.

Time frame: At 6 months

Secondary Outcomes

Cardiorespiratory fitness

Using the Six minutes walking test

Time frame: Change from baseline cardiorespiratory fitness at 3 months

Upper limb muscle strength

Using the Handgrip strength test

Time frame: Change from baseline muscle strength at 3 months

Lower limb muscle strength

Using the Isometric Leg Press strength test

Time frame: Change from baseline muscle strength at 3 months

Upper limb flexibility

Using the Back Scratch test

Time frame: Change from baseline flexibility at 3 months

Lower limb flexibility

Using the Sit and Reach test

Time frame: Change from baseline flexibility at 3 months

Body mass index

Calculated from weight and height

Time frame: Change from baseline antrhopometric values at 3 months

Waist-hip ratio

Calculated usign the waist and hip circumferences

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: Change from baseline physical activity level at 3 months