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

November 7, 2023 updated by: UNICANCER

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49000
        • ICO Paul Papin
      • Annecy, France, 74474
        • CH Annecy Genevois - Site d'Annecy
      • Besançon, France, 25000
        • CHRU De Besancon
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Cholet, France, 49300
        • CH de Cholet
      • Grenoble, France, MD Phd
        • GHMG - Institut Daniel Hollard
      • La Roche-sur-Yon, France, 85925
        • CHD Vendee
      • Lyon, France, 69000
        • Hospices Civils de Lyon - Hopital Louis Pradel
      • Marseille, France, 13000
        • CHU La Timone
      • Nantes, France, 44000
        • ICO RenéGauducheau
      • Nîmes, France, 30000
        • CH Nimes - Institut de Cancérologie du Gard
      • Paris, France, 75005
        • Institut Curie Paris
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Saint-Cloud, France, 92000
        • INSTITUT CURIE - Site René Huguenin St Cloud
      • Saint-Mandé, France, 94160
        • Hia Begin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient's ≥18 years old.
  2. Patient treated for a metastatic solid tumour within the following 4 cohorts: breast cancer, kidney cancer, lung cancer, and other tumours treated with oral targeted therapies (including melanomas, sarcomas, hepatic sarcomas, and colon cancers).
  3. Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy.
  4. Patients may have been treated with immunotherapy.
  5. Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
  6. Life expectancy of ≥3 months.
  7. ECOG performance status ≤2.
  8. Patients able to comply with the constraints of the SPEP protocol.
  9. Pain under control (VAS ˂3; 0-10 scale).
  10. Haemoglobin level ≥9 g/dL.
  11. Patient must have signed the informed consent form before any study-related procedures.
  12. Patients must have public health insurance coverage.

Exclusion Criteria:

  1. Patient receiving an injectable targeted therapy.
  2. Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed)
  3. Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed).
  4. Patient with known risk of fracture, symptomatic cardiac insufficiency (NYHA-3), respiratory insufficiency (grade 3), intense pain not controlled with analgesic treatment, and/or neuropathy (grade 3).
  5. Patients with a history of cancer in the last 5 years (except basal cell carcinoma adequately treated and in situ cervical cancer treated and cured).
  6. Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg.
  7. Bone metastases with risk of fractures.
  8. Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule.
  9. Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol.
  10. Persons deprived of liberty or under guardianship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARM A: A
Supervised physical exercise programs (SPEP)
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
Active Comparator: ARM B: B
Adapted physical activity (APA)
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FACT-F relative on Fatigue
Time Frame: Month 3 ( M3)
Self reported Questionnaires
Month 3 ( M3)
FACT-G
Time Frame: Month3 ( M3)
Self Reported Questionnaire relative on Well-Being Patient
Month3 ( M3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 75 months
Progression Free Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 75 months
OS
Time Frame: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months
Overall Survival
From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months
Quality of life
Time Frame: Month 1, Month 2, Month 3, and every 3 months for 1 year
Self reported Questionnaire on quality of life
Month 1, Month 2, Month 3, and every 3 months for 1 year
Fatigue
Time Frame: Month 1, Month 2, Month 3, and every 3 months for 1 year
Self reported Questionnaire FACT-F on Fatigue
Month 1, Month 2, Month 3, and every 3 months for 1 year
Fatigue
Time Frame: Month 1, Month 2, Month 3, and every 3 months for 1 year
visual analogic scale for fatigue
Month 1, Month 2, Month 3, and every 3 months for 1 year
Pain
Time Frame: Month 1, Month 2, Month 3, and every 3 months for 1 year
visual analogic scale for pain (VAS)
Month 1, Month 2, Month 3, and every 3 months for 1 year
Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria )
Time Frame: Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year
Compliance about oral targeted therapy
Time Frame: Baseline, Month 1, Month 2, Month 3
Self reported Questionnaire Morisky-Green
Baseline, Month 1, Month 2, Month 3
Benefit of physical activity: walk
Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
6 minutes walking test
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Benefit of physical activity muscle function
Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
muscle function
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Benefit of physical activity muscle strength
Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
muscle strength
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Physical Activity IPAQ
Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
self reported Questionnaire IPAQ ( International Physical Activity Questionnaire)
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Physical Activity, Body Mass Index
Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Body Mass Index
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Scores of anxiety and depression
Time Frame: Baseline, Month 1, Month 2, Month 3
Hospital Anxiety and Depression Scale (HADs)
Baseline, Month 1, Month 2, Month 3
Cognitive functions
Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Self reported questionnaire FACT-Cog
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Evaluation of Ingesta, Anorexia
Time Frame: Baseline, Month 3
Ingesta
Baseline, Month 3
Evaluation of Ingesta, VAS
Time Frame: Baseline, Month 3
VAS
Baseline, Month 3
Evaluation of Anorexia
Time Frame: Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Self reported FAACT (module A-C)
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNICANCER

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CAMI: Sport & Cancer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Florence JOLY, MD PhD, Centre Francois Baclesse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UC-0106/1510 SdS 01 QUALIOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Home Based Standardised Adapted Physical Activity Programme

Clinical Trials on Supervised physical exercise programs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings