Impact of a Collaborative Program of Physical Activity of Newly-diagnosed Cancer Patients (PROGRESS)

April 7, 2025 updated by: University Hospital, Toulouse

Impact of a Collaborative Program of Customized, Adaptive and Supervised Physical Activity on Adherence, Fitness, Quality of Life and Resilience of Newly-diagnosed Cancer Patients

During the last twenty years, the cancer overall incidence has been increasing in europe and developed countries, while diagnostic and therapeutic progress have contributes to a reduction in mortality. Currently, almost 4 million people are treated or followed for cancer in France. The physical, psychological and social after-effects are significant.

Adaptated physical activity plays an important role in the rehabilitation process. Overall, meta-analyses carried-out with most frequent cancers demonstrate that physical activity practiced would allow an improvement in quality of life, tolerance to anticancer treatments and survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, two-arm parallel-group randomizes (in a 1:1 ratio), open-label, controlled intervention clinical trial of the comparison of long term adherence to physical activity between an adaptative, customized and collaborative exercise program and standard exercise prescription in patients with newly diagnosed cancer.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • newly-diagnosed cancer patient
  • able to start a program of physical activity within the first year follow diagnosis
  • performance status between 0 to 2

Exclusion Criteria:

  • uncontrolled cardiovascular disease
  • peripheral neuropathy grade 3-4 with risk of falling
  • bone metastasis with risk of bone fracture
  • platelets <100X109/L
  • hemoglobin <8g/dL
  • patient under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adaptative Physical Activity
Other: Adaptative Physical Activity
12 weeks of a collaborative program of customized, adaptative and supervised physical activity by sports instructor
No Intervention: Standard Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of physical activity session
Time Frame: 2 years
improvement of long-term adhesion to physical activity
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Stéphanie MOTTON, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/21/0600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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