AzTrials
AzTrials

Mixed CancerCHOiCENCT04226508

"CHOiCE"! Choose Health: Oncological Patients Cenetered Exercise

A study testing Physical exercise in people with Mixed Cancer, run by Universita di Verona at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Mixed Cancer
What is being tested?
Physical exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesItaly
Study dates
1 Sep 2019to 30 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Italian League for Fight Cancer

    Biella, Turin, 13900

  • University of Verona

    Verona, 37131

Other trials in Italy

About this study

Official title: Different Modalities of Exercise for Physical Activity Promotion in Cancer Patients

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
Being tested
Physical exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exerciseOther

    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.
Study groups in NCT04226508
Study groupRoleWhat they receive
ControlNo interventionNot described
Physical exerciseExperimentalNot described
Receives: Other: Physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of participants with an adverse event

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

    Measured: Change from baseline to 12 weeks

  2. The eligibility rate

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

    Measured: At 12 weeks

  3. The recruitment rate

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

    Measured: At 12 weeks

  4. The adherence to exercise protocol

    Measured by the total number of exercise sessions attended

    Measured: At 12 weeks

  5. 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.

    Measured: At 6 months

Secondary outcomes (10)

  1. Cardiorespiratory fitness

    Using the Six minutes walking test

    Measured: Change from baseline cardiorespiratory fitness at 3 months

  2. Upper limb muscle strength

    Using the Handgrip strength test

    Measured: Change from baseline muscle strength at 3 months

  3. Lower limb muscle strength

    Using the Isometric Leg Press strength test

    Measured: Change from baseline muscle strength at 3 months

  4. Upper limb flexibility

    Using the Back Scratch test

    Measured: Change from baseline flexibility at 3 months

  5. Lower limb flexibility

    Using the Sit and Reach test

    Measured: Change from baseline flexibility at 3 months

  6. Body mass index

    Calculated from weight and height

    Measured: Change from baseline antrhopometric values at 3 months

  7. Waist-hip ratio

    Calculated usign the waist and hip circumferences

    Measured: Change from baseline antrhopometric values at 3 months

  8. Enjoyment

    Using the Physical Activity Enjoyment Scale (PACES), ranging from 0 (no enjoyment) to 75 (max enjoyment)

    Measured: Change from baseline enjoyment at 3 months

  9. 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)

    Measured: Change from baseline quality of life at 3 months

  10. 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.

    Measured: Change from baseline physical activity level at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start1 Sep 2019
  3. Primary completion30 Jun 2023
  4. Study completion30 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The CHOiCE includes different substudies, with different study designs, i.e., RCT, single arm.
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04226508
Sponsor's protocol ID
33320
Acronym
CHOiCE
Status last verified
Nov 2023
First submitted
20 Dec 2019
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Avancini A, Borsati A, Adamoli G, Toniolo L, Ciurnelli C, Trevisan A, Belluomini L, Trestini I, Tregnago D, Sposito M, Insolda J, Manduca S, Auriemma A, Fiorio E, Milella M, Lanza M, Schena F, Pilotto S. Real-world feasibility and effectiveness of a personalized exercise program during cancer treatment: results from the CHOiCE prospective study. Oncologist. 2026 May 8;31(6):oyag153. doi: 10.1093/oncolo/oyag153.

    PubMed 42015889

  • 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.

    PubMed 38206849

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise in people with Mixed Cancer, run by Universita di Verona at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants with an adverse event (time frame: Change from baseline to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04226508, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in