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| Name | Class |
|---|---|
| CAMI: Sport & Cancer | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A: A | Experimental | Supervised physical exercise programs (SPEP) |
|
| ARM B: B | Active Comparator | Adapted physical activity (APA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised physical exercise programs | Behavioral | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence JOLY, MD PhD | Centre François Baclesse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO Paul Papin | Angers | 49000 | France | |||
| CH Annecy Genevois - site d'Annecy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33036567 | Derived | 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. |
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Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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|
| Adapted physical activity | Behavioral | 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 |
|
| 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 |
| Annecy |
| 74474 |
| France |
| CHRU de Besançon | Besançon | 25000 | France |
| Centre François Baclesse | Caen | 14076 | France |
| CH de Cholet | Cholet | 49300 | France |
| GHMG - Institut Daniel Hollard | Grenoble | MD Phd | France |
| CHD Vendée | La Roche-sur-Yon | 85925 | France |
| Hospices Civils de Lyon - Hôpital Louis Pradel | Lyon | 69000 | France |
| CHU La Timone | Marseille | 13000 | France |
| ICO RenéGauducheau | Nantes | 44000 | France |
| CH Nimes - Institut de Cancérologie du Gard | Nîmes | 30000 | France |
| Institut Curie Paris | Paris | 75005 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| INSTITUT CURIE - Site René Huguenin St Cloud | Saint-Cloud | 92000 | France |
| HIA Begin | Saint-Mandé | 94160 | France |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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