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ACTIVE NOT RECRUITING
NCT03169075
NA

QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program

Sponsor: UNICANCER

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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

BEHAVIORAL

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