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

NCT03169075 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

  • Home Based Standardised Adapted Physical Activity Programme
  • Patients Taking Oral Targeted Therapy for Metastatic Cancer

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

Sponsors & Collaborators

  • CAMI: Sport & Cancer

    collaborator UNKNOWN

  • UNICANCER

    lead OTHER

Principal Investigators

  • Florence JOLY, MD PhD · Centre François Baclesse

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2024-09-30
Completion
2028-07-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169075 on ClinicalTrials.gov