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QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program
Sponsor: UNICANCER
Summary
This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) \<3/10), and life expectancy ≥3 months.
Official title: Study Evaluating the Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program, for Metastatic Cancer Patients Receiving Oral Targeted Therapy: The UNICANCER SdS 01 QUALIOR Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2017-07-11
Completion Date
2028-07-11
Last Updated
2024-11-12
Healthy Volunteers
No
Conditions
Interventions
Supervised physical exercise programs
A weekly supervised physical activity session of 60 min at the patient's home is planned for 3 months. These sessions will be supervised by an educator or physiotherapist trained, with respect to the pathology and the clinical study, specifically for this activity (Fédération Française Sport et Cancer) . The proposed exercises will be normalized and adapted to each patient's profile. Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ, Evaluation by a coach VAE
Adapted physical activity
Program based on the recommendations for performing a physical activity. A booklet containing physical activity recommendations will be given to the patients after randomization. The weekly sessions at the patients home for the experimental group (Program A) must begin as soon as possible within the 15 days after starting oral targeted therapy. Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ
Locations (15)
ICO Paul Papin
Angers, France
CH Annecy Genevois - site d'Annecy
Annecy, France
CHRU de Besançon
Besançon, France
Centre François Baclesse
Caen, France
CH de Cholet
Cholet, France
GHMG - Institut Daniel Hollard
Grenoble, France
CHD Vendée
La Roche-sur-Yon, France
Hospices Civils de Lyon - Hôpital Louis Pradel
Lyon, France
CHU La Timone
Marseille, France
ICO RenéGauducheau
Nantes, France
CH Nimes - Institut de Cancérologie du Gard
Nîmes, France
Institut Curie Paris
Paris, France
Centre Eugène Marquis
Rennes, France
INSTITUT CURIE - Site René Huguenin St Cloud
Saint-Cloud, France
HIA Begin
Saint-Mandé, France