Clinical trial NCT04226508: "CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise
Official title: Different Modalities of Exercise for Physical Activity Promotion in Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mixed Cancer
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The CHOiCE includes different substudies, with different study designs, i.e., RCT, single arm.
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The number of participants with an adverse event
timeFrame: Change from baseline to 12 weeks
measure: The eligibility rate
timeFrame: At 12 weeks
measure: The recruitment rate
timeFrame: At 12 weeks
measure: The adherence to exercise protocol
timeFrame: At 12 weeks
measure: The dropouts rate
timeFrame: At 6 months
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Change from baseline cardiorespiratory fitness at 3 months
measure: Upper limb muscle strength
timeFrame: Change from baseline muscle strength at 3 months
measure: Lower limb muscle strength
timeFrame: Change from baseline muscle strength at 3 months
measure: Upper limb flexibility
timeFrame: Change from baseline flexibility at 3 months
measure: Lower limb flexibility
timeFrame: Change from baseline flexibility at 3 months
measure: Body mass index
timeFrame: Change from baseline antrhopometric values at 3 months
measure: Waist-hip ratio
timeFrame: Change from baseline antrhopometric values at 3 months
measure: Enjoyment
timeFrame: Change from baseline enjoyment at 3 months
measure: Quality of life (QoL)
timeFrame: Change from baseline quality of life at 3 months
measure: Physical activity level
timeFrame: Change from baseline physical activity level at 3 months
Other outcomes:
Locations:
city: Biella
country: Italy
facility: Italian League for Fight Cancer
state: Turin
city: Verona
country: Italy
facility: University of Verona
Study officials:
affiliation: Universita di Verona
name: Massimo Lanza
role: PRINCIPAL_INVESTIGATOR
References: