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

Study Overview
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Brief Summary
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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
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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

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

Intervention / Treatment
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* Behavioral: Supervised physical exercise programs
* Behavioral: Adapted physical activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A: A<br>Supervised physical exercise programs (SPEP) | Behavioral: Supervised physical exercise programs<br>* 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<br>|
| Active Comparator: ARM B: B<br>Adapted physical activity (APA) | Behavioral: Adapted physical activity<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACT-F relative on Fatigue | Self reported Questionnaires | Month 3 ( M3) | 
| FACT-G | Self Reported Questionnaire relative on Well-Being Patient | Month3 ( M3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | 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 | 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 | Self reported Questionnaire on quality of life | Month 1, Month 2, Month 3, and every 3 months for 1 year | 
| Fatigue | Self reported Questionnaire FACT-F on Fatigue | Month 1, Month 2, Month 3, and every 3 months for 1 year | 
| Fatigue | visual analogic scale for fatigue | Month 1, Month 2, Month 3, and every 3 months for 1 year | 
| Pain | 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 ) | 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 | Self reported Questionnaire Morisky-Green | Baseline, Month 1, Month 2, Month 3 | 
| Benefit of physical activity: walk | 6 minutes walking test | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | 
| Benefit of physical activity muscle function | muscle function | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | 
| Benefit of physical activity muscle strength | muscle strength | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | 
| Physical Activity IPAQ | 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 | Body Mass Index | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | 
| Scores of anxiety and depression | Hospital Anxiety and Depression Scale (HADs) | Baseline, Month 1, Month 2, Month 3 | 
| Cognitive functions | Self reported questionnaire FACT-Cog | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | 
| Evaluation of Ingesta, Anorexia | Ingesta | Baseline, Month 3 | 
| Evaluation of Ingesta, VAS | VAS | Baseline, Month 3 | 
| Evaluation of Anorexia | Self reported FAACT (module A-C) | Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adapted physical activity, Oral targeted therapy, Advanced cancer, Fatigue, Quality of life, Randomized Study