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Following an insufficient recruitment, the sponsor decided to halt prematurely inclusions
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Oral anticancer treatments account a quarter of cancer treatments. These oral treatments are allowed at home, avoid hospitalization and limit the use of central venous routes. Oral treatments cause many side effects and patients are reluctant to report them because they are afraid that their treatment will be changed. But when these side effects are poorly managed, they can reduce adherence to treatment.
The main hypothesis of this randomized study is that the combination of an initial consultation with a trio (nurse, doctor, pharmacist) and a weekly telephone nurse follow-up during the administration of oral anticancer treatments decreases the rate and duration of side effects.
The main objective is to evaluate the impact at 3 months of a optimized management by an initial consultation with a trio nurse, doctor, pharmacist and a weekly nurse telephone follow-up versus a standard management on the level of digestive, skin and mucosal side effects of grade 3 in patients with oral chemotherapy.
This randomized study is realized in patients with kidney or breast cancer.
Oral anticancer treatments account a quarter of cancer treatments. These oral treatments are allowed at home, avoid hospitalization and limit the use of central venous routes. Oral treatments cause many adverse effects (nausea, vomiting, digestive disorders, skin and mucous ...) that can significantly impact the quality of life. Patients are reluctant to report side effects because they are afraid that their treatment will be changed. But if these side effects are poorly managed, they can reduce adherence to treatment. The majority of devices are evaluated post-treatment and none relates to the treatment administration period.
The main hypothesis of this randomized study is that the combination of an initial consultation with a trio (nurse, doctor, pharmacist) and a weekly telephone nurse follow-up during the administration of treatments decreases the rate and duration of digestive, cutaneous and mucosal side effects.
The main objective is to evaluate the impact at 3 months of a optimized management by an initial consultation with a trio nurse, doctor, pharmacist and a weekly nurse telephone follow-up versus a standard management on the level of digestive, skin and mucosal side effects of grade 3 in patients with oral chemotherapy (Xeloda® or Sutent®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| accented follow-up | Experimental | Initial consultation with a trio oncologist / pharmacist / nurse; weekly telephone follow-up with a nurse between each treatment and follow-up visit with the oncologist at each renewal of treatment. |
|
| standard follow-up | No Intervention | Initial consultation with the oncologist and follow-up visit with the oncologist |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| managment of oral therapy | Other | Initial consultation with a trio oncologist / pharmacist / nurse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of side effects | Side effects evaluated: digestive, cutaneous and mucosal grade 3 and 4 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Dijon | 21000 | France |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |