"CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise

NCT04226508 | Unknown

• 1 other identifier: 33320
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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).

Conditions

Mixed Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Cardiorespiratory fitness

  Change from baseline cardiorespiratory fitness at 3 months

• Upper limb muscle strength

  Change from baseline muscle strength at 3 months

• Lower limb muscle strength

  Change from baseline muscle strength at 3 months

• Upper limb flexibility

  Change from baseline flexibility at 3 months

• Lower limb flexibility

  Change from baseline flexibility at 3 months

Study Arms (2)

Control

NO INTERVENTION

Physical exercise

EXPERIMENTAL

Other: Physical exercise

Interventions

Physical exercise OTHER

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.

Physical exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a confirmed cancer diagnosis;
• ≥ 8 weeks post-surgical procedure;
• Medical clearance for participation provided by primary care physician or oncologist;
• Informed consent signed;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (2)

Italian League for Fight Cancer

Biella, Turin, 13900, Italy

Location

University of Verona

Verona, 37131, Italy

Location

Related Publications (1)

• Avancini A, Borsati A, Baldo E, Ciurnelli C, Trestini I, Tregnago D, Belluomini L, Sposito M, Insolda J, Auriemma A, Fiorio E, Piacentini M, Schena F, Milella M, Pilotto S. A Feasibility Study Investigating an Exercise Program in Metastatic Cancer Based on the Patient-Preferred Delivery Mode. Oncologist. 2024 Jun 3;29(6):e828-e836. doi: 10.1093/oncolo/oyae002.

  PMID: 38206849 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Massimo Lanza

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: The CHOiCE includes different substudies, with different study designs, i.e., RCT, single arm.

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 13, 2020
• Study Start: September 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

IT (2)