Back to resultsQUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program (QUALIOR)
Primary Purpose
Home Based Standardised Adapted Physical Activity Programme, Patients Taking Oral Targeted Therapy for Metastatic Cancer
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Supervised physical exercise programs
Adapted physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Home Based Standardised Adapted Physical Activity Programme focused on measuring Adapted physical activity, Oral targeted therapy, Advanced cancer, Fatigue, Quality of life, Randomized Study
Eligibility Criteria
Inclusion Criteria:
- Patient's ≥18 years old.
- 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).
- Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy.
- Patients may have been treated with immunotherapy.
- Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
- Life expectancy of ≥3 months.
- ECOG performance status ≤2.
- Patients able to comply with the constraints of the SPEP protocol.
- Pain under control (VAS ˂3; 0-10 scale).
- Haemoglobin level ≥9 g/dL.
- Patient must have signed the informed consent form before any study-related procedures.
- Patients must have public health insurance coverage.
Exclusion Criteria:
- Patient receiving an injectable targeted therapy.
- Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed)
- Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed).
- 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).
- 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).
- Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg.
- Bone metastases with risk of fractures.
- Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule.
- Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol.
- Persons deprived of liberty or under guardianship.
Sites / Locations
- ICO Paul Papin
- CH Annecy Genevois - site d'Annecy
- CHRU de Besançon
- Centre François Baclesse
- CH de Cholet
- GHMG - Institut Daniel Hollard
- CHD Vendée
- Hospices Civils de Lyon - Hôpital Louis Pradel
- CHU La Timone
- ICO RenéGauducheau
- CH Nimes - Institut de Cancérologie du Gard
- Institut Curie Paris
- Centre Eugène Marquis
- INSTITUT CURIE - Site René Huguenin St Cloud
- HIA Begin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ARM A: A
ARM B: B
Arm Description
Supervised physical exercise programs (SPEP)
Adapted physical activity (APA)
Outcomes
Primary Outcome Measures
FACT-F relative on Fatigue
Self reported Questionnaires
FACT-G
Self Reported Questionnaire relative on Well-Being Patient
Secondary Outcome Measures
PFS
Progression Free Survival
OS
Overall Survival
Quality of life
Self reported Questionnaire on quality of life
Fatigue
Self reported Questionnaire FACT-F on Fatigue
Fatigue
visual analogic scale for fatigue
Pain
visual analogic scale for pain (VAS)
Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria )
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Compliance about oral targeted therapy
Self reported Questionnaire Morisky-Green
Benefit of physical activity: walk
6 minutes walking test
Benefit of physical activity muscle function
muscle function
Benefit of physical activity muscle strength
muscle strength
Physical Activity IPAQ
self reported Questionnaire IPAQ ( International Physical Activity Questionnaire)
Physical Activity, Body Mass Index
Body Mass Index
Scores of anxiety and depression
Hospital Anxiety and Depression Scale (HADs)
Cognitive functions
Self reported questionnaire FACT-Cog
Evaluation of Ingesta, Anorexia
Ingesta
Evaluation of Ingesta, VAS
VAS
Evaluation of Anorexia
Self reported FAACT (module A-C)
Full Information
NCT ID
NCT03169075
First Posted
May 22, 2017
Last Updated
August 31, 2023
Sponsor
UNICANCER
Collaborators
CAMI: Sport & Cancer
1. Study Identification
Unique Protocol Identification Number
NCT03169075
Brief Title
QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program
Acronym
QUALIOR
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
October 11, 2023 (Anticipated)
Study Completion Date
July 11, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
CAMI: Sport & Cancer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Home Based Standardised Adapted Physical Activity Programme, Patients Taking Oral Targeted Therapy for Metastatic Cancer
Keywords
Adapted physical activity, Oral targeted therapy, Advanced cancer, Fatigue, Quality of life, Randomized Study
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARM A: A
Arm Type
Experimental
Arm Description
Supervised physical exercise programs (SPEP)
Arm Title
ARM B: B
Arm Type
Active Comparator
Arm Description
Adapted physical activity (APA)
Intervention Type
Behavioral
Intervention Name(s)
Supervised physical exercise programs
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Adapted physical activity
Intervention Description
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
Primary Outcome Measure Information:
Title
FACT-F relative on Fatigue
Description
Self reported Questionnaires
Time Frame
Month 3 ( M3)
Title
FACT-G
Description
Self Reported Questionnaire relative on Well-Being Patient
Time Frame
Month3 ( M3)
Secondary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
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
Title
OS
Description
Overall Survival
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
Title
Quality of life
Description
Self reported Questionnaire on quality of life
Time Frame
Month 1, Month 2, Month 3, and every 3 months for 1 year
Title
Fatigue
Description
Self reported Questionnaire FACT-F on Fatigue
Time Frame
Month 1, Month 2, Month 3, and every 3 months for 1 year
Title
Fatigue
Description
visual analogic scale for fatigue
Time Frame
Month 1, Month 2, Month 3, and every 3 months for 1 year
Title
Pain
Description
visual analogic scale for pain (VAS)
Time Frame
Month 1, Month 2, Month 3, and every 3 months for 1 year
Title
Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria )
Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time Frame
Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year
Title
Compliance about oral targeted therapy
Description
Self reported Questionnaire Morisky-Green
Time Frame
Baseline, Month 1, Month 2, Month 3
Title
Benefit of physical activity: walk
Description
6 minutes walking test
Time Frame
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Title
Benefit of physical activity muscle function
Description
muscle function
Time Frame
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Title
Benefit of physical activity muscle strength
Description
muscle strength
Time Frame
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Title
Physical Activity IPAQ
Description
self reported Questionnaire IPAQ ( International Physical Activity Questionnaire)
Time Frame
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Title
Physical Activity, Body Mass Index
Description
Body Mass Index
Time Frame
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Title
Scores of anxiety and depression
Description
Hospital Anxiety and Depression Scale (HADs)
Time Frame
Baseline, Month 1, Month 2, Month 3
Title
Cognitive functions
Description
Self reported questionnaire FACT-Cog
Time Frame
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
Title
Evaluation of Ingesta, Anorexia
Description
Ingesta
Time Frame
Baseline, Month 3
Title
Evaluation of Ingesta, VAS
Description
VAS
Time Frame
Baseline, Month 3
Title
Evaluation of Anorexia
Description
Self reported FAACT (module A-C)
Time Frame
Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient's ≥18 years old.
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).
Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy.
Patients may have been treated with immunotherapy.
Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
Life expectancy of ≥3 months.
ECOG performance status ≤2.
Patients able to comply with the constraints of the SPEP protocol.
Pain under control (VAS ˂3; 0-10 scale).
Haemoglobin level ≥9 g/dL.
Patient must have signed the informed consent form before any study-related procedures.
Patients must have public health insurance coverage.
Exclusion Criteria:
Patient receiving an injectable targeted therapy.
Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed)
Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed).
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).
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).
Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg.
Bone metastases with risk of fractures.
Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule.
Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol.
Persons deprived of liberty or under guardianship.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence JOLY, MD PhD
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CH Annecy Genevois - site d'Annecy
City
Annecy
ZIP/Postal Code
74474
Country
France
Facility Name
CHRU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
CH de Cholet
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
GHMG - Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
MD Phd
Country
France
Facility Name
CHD Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Hospices Civils de Lyon - Hôpital Louis Pradel
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
CHU La Timone
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
ICO RenéGauducheau
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CH Nimes - Institut de Cancérologie du Gard
City
Nîmes
ZIP/Postal Code
30000
Country
France
Facility Name
Institut Curie Paris
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
INSTITUT CURIE - Site René Huguenin St Cloud
City
Saint-Cloud
ZIP/Postal Code
92000
Country
France
Facility Name
HIA Begin
City
Saint-Mandé
ZIP/Postal Code
94160
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
33036567
Citation
Joly F, Lefeuvre-Plesse C, Garnier-Tixidre C, Helissey C, Menneveau N, Zannetti A, Salas S, Houede N, Abadie-Lacourtoisie S, Stefani L, Nenan S, Rieger I, Durand-Zaleski I, Descotes JM, Anota A. Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial. BMC Cancer. 2020 Oct 9;20(1):975. doi: 10.1186/s12885-020-07381-4.
Results Reference
derived
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QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program
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