NCT03623490

Optimizing the Management of Patients With Oral Therapy

Optimizing the Management of Patients With Oral Therapy: a Randomized Trial Evaluating the Impact of Management on the Occurrence of Side Effects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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®).

Conditions

• Kidney Cancer
• Breast Cancer

Interventions

Type	Name	Description
OTHER	managment of oral therapy	Initial consultation with a trio oncologist / pharmacist / nurse

Timeline

• Start date: 2018-05-22
• Primary completion: 2021-05-11
• Completion: 2021-05-11
• First posted: 2018-08-09
• Last updated: 2023-10-17

Locations

1 site across 1 country: France