QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program
NCT ID: NCT03169075
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
190 participants
INTERVENTIONAL
2017-07-11
2028-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ARM A: A
Supervised physical exercise programs (SPEP)
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
ARM B: B
Adapted physical activity (APA)
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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CAMI: Sport & Cancer
UNKNOWN
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Florence JOLY, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre François Baclesse
Locations
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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
Countries
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References
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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.
Other Identifiers
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UC-0106/1510 SdS 01 QUALIOR
Identifier Type: -
Identifier Source: org_study_id
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