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

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05723471
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 57
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Adaptative Physical Activity	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Oct 31, 2027
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of physical activity session [2 years]

   improvement of long-term adhesion to physical activity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stéphanie MOTTON	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT05723471
• Other Study ID Numbers: RC31/21/0600
• First Posted: Feb 10, 2023
• Last Update Posted: Feb 10, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Toulouse: Adaptative physical activity; Cancer; Quality of Life

Study Results

No Results Posted as of Feb 10, 2023