Evolution of the Physical Condition in Treated Cancer Patients
PROTECT-01
2 other identifiers
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
September 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 11, 2020
February 1, 2020
1 year
April 18, 2019
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
evolution of exercise tolerance
To describe exercise tolerance, by a six-minute walk test, in patients treated for a cancer (of lung, breast or colon) after 8 weeks of treatment.
change from baseline exercise tolerance at 12 weeks after the end of the treatment
Secondary Outcomes (12)
measurement of parameters reflecting the physical condition
change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
change from baseline physical condition at 12 weeks after the end of the treatment
- +7 more secondary outcomes
Study Arms (1)
experimental: observational cohort
EXPERIMENTALEvaluation of the physical condition and the quality of life
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient with psychiatric, neurologic or musculoskeletal disorders
- Pregnant or breastfeeding women
- Minor or protected adult
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Paul Strauss
Strasbourg, 67200, France
Related Publications (1)
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.
PMID: 32903594DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland SCHOTT, Md
Centre Paul Strauss
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2019
First Posted
May 21, 2019
Study Start
September 17, 2019
Primary Completion
September 17, 2020
Study Completion
June 1, 2021
Last Updated
February 11, 2020
Record last verified: 2020-02