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| Name | Class |
|---|---|
| Hôpital Privé de la Loire | UNKNOWN |
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The purpose of this study is to assess the effectiveness of a nurse telephone interview in the management of cancer patients treated by oral chemotherapy. This is a multicenter prospective randomized controlled pragmatic interventional trial conducted in collaboration with two oncology care facilities. Eligible population consists of all patients suffering from advanced cancer and treated by oral chemotherapy except hormonotherapy. 184 patients will be enrolled in the study. The experimental group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care, and telephone interviews by a nurse every 14 +/- 2 days for 6 months. The control group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care.
The effectiveness of the intervention will be evaluated by a toxicity score of the 9 most common side effects of oral cancer (oral mucositis, hand-foot syndrome, diarrhea, nausea, vomiting, pain, asthenia, rash and anorexia) officers from NCI CTCAE v4.0-(Common Toxicity Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 Toxicity grades).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse phone call | Experimental | a nurse will interview patients by phone every 14 +/- 2 days for 6 months |
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| Control Group | No Intervention | Common practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse phone call | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Toxicity score | Toxicity Score 9 most common side effects of oral chemotherapy (oral mucositis, hand-foot syndrome, diarrhea, nausea, vomiting, pain, asthenia, rash and anorexia) officers from the NCI-CTCAE v4.0 (Common Toxicity Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 toxicity grades) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathieu ORIOL, MD | Contact | 04 77 91 70 71 | mathieu.oriol@icloire.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Privé de la Loire | Recruiting | Saint-Etienne | 42100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33409726 | Derived | Bouleftour W, Muron T, Guillot A, Tinquaut F, Rivoirard R, Jacquin JP, Saban-Roche L, Boussoualim K, Tavernier E, Augeul-Meunier K, Collard O, Mery B, Pupier S, Oriol M, Bourmaud A, Fournel P, Vassal C. Effectiveness of a nurse-led telephone follow-up in the therapeutic management of patients receiving oral antineoplastic agents: a randomized, multicenter controlled trial (ETICCO study). Support Care Cancer. 2021 Aug;29(8):4257-4267. doi: 10.1007/s00520-020-05955-3. Epub 2021 Jan 7. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Institut de Cancerologie de la Loire | Recruiting | Saint-Priest-en-Jarez | 42271 | France |
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