Evolution of the Physical Condition in Treated Cancer Patients

NCT ID: NCT03956641

Last Updated: 2020-02-11

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2021-06-01

Brief Summary

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Adaptated Physical Activity (APA) during treatment of cancer is one of the actual global health recommendation because of the benefits observed in several parameters evaluated in many clinical studies. A best knowledge of the physical and medical characteristics of patients, including type of cancer and type of treatment, is primordial to optimize the patient care and the effectiveness of APA programs.

Descriptive, explorative and prospective study of 3 different populations:

One population with locally advanced or metastatic non-small cell lung cancer treated with multiple therapeutic lines. Two different populations of early cancer patients and treated with a platinum-based regimen for colon cancer and a taxane-based chemotherapy for breast cancer.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer Metastatic Breast Cancer Female Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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experimental: observational cohort

Evaluation of the physical condition and the quality of life

Group Type EXPERIMENTAL

Adaptated Physical Activity

Intervention Type OTHER

Evaluation of the physical condition and the quality of life during the course of treatment (after 8 weeks of treatment) and at the end of the treatment's line (except for breast cancer patients)

Interventions

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Adaptated Physical Activity

Evaluation of the physical condition and the quality of life during the course of treatment (after 8 weeks of treatment) and at the end of the treatment's line (except for breast cancer patients)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Woman with breast cancer treated with adjuvant chemotherapy (taxane) or patient with colon cancer treated with adjuvant regimen (FOLFOX) or patient with locally advanced or metastatic lung cancer
* Patient without contraindication to the study-specific assessments
* Eastern Cooperative Oncology Group ≤ 2
* Age ≥ 18 years old
* Life expectancy \> 6 months
* Able to speak, read and understand French
* Written informed consent obtained from the patient
* Registration in a national health care system

Exclusion Criteria

* Patient with psychiatric, neurologic or musculoskeletal disorders
* Pregnant or breastfeeding women
* Minor or protected adult
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Paul Strauss

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland SCHOTT, Md

Role: PRINCIPAL_INVESTIGATOR

Centre Paul Strauss

Locations

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Centre Paul Strauss

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Valerie SARTORI

Role: CONTACT

+33 388 25 85 41

Joris MALLARD

Role: CONTACT

+ 33 388 25 85 68

Facility Contacts

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SARTORI Valérie

Role: primary

+33 368 76 72 23

References

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Mallard J, Hucteau E, Schott R, Petit T, Demarchi M, Belletier C, Ben Abdelghani M, Carinato H, Chiappa P, Fischbach C, Kalish-Weindling M, Bousiniere A, Dufour S, Favret F, Pivot X, Hureau TJ, Pagano AF. Evolution of Physical Status From Diagnosis to the End of First-Line Treatment in Breast, Lung, and Colorectal Cancer Patients: The PROTECT-01 Cohort Study Protocol. Front Oncol. 2020 Aug 7;10:1304. doi: 10.3389/fonc.2020.01304. eCollection 2020.

Reference Type DERIVED
PMID: 32903594 (View on PubMed)

Other Identifiers

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2019-A00848-49

Identifier Type: OTHER

Identifier Source: secondary_id

2019-001

Identifier Type: -

Identifier Source: org_study_id

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