"CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise

NCT ID: NCT04226508

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2024-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physical exercise

Group Type: EXPERIMENTAL

Physical exercise

Intervention Type: 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.

Interventions

Physical exercise

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Alice Avancini

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Lanza

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

Italian League for Fight Cancer

Biella, Turin, Italy

University of Verona

Verona, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 38206849 (View on PubMed)

Other Identifiers

33320

Identifier Type: -

Identifier Source: org_study_id