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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Adaptative Physical Activity

Group Type EXPERIMENTAL

Adaptative Physical Activity

Intervention Type OTHER

12 weeks of a collaborative program of customized, adaptative and supervised physical activity by sports instructor

Standard Exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adaptative Physical Activity

12 weeks of a collaborative program of customized, adaptative and supervised physical activity by sports instructor

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No