Optimizing the Management of Patients With Oral Therapy

Breast Cancer Clinical Trial

— IPAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03623490
• Other study ID #: IPAC
• Status: Terminated
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: May 11, 2021

Study information

• Verified date: October 2023
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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®).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient over 18 years old.

2. Men or women with kidney cancer treated with Sutent® chemotherapy (Cohort 1) according to the following schedule: 42-day course: 28 days of treatment + 14 days of break therapeutic)

3. Women with breast cancer treated with Xeloda® (Cohort 2) chemotherapy according to the following schedule: 21-day course: 14 days of treatment + 7 days of therapeutic break).

4. Patient (e) able to understand French read, write, speak.

5. Patient who received information about the study.

6. Written and signed consent.

7. Affiliation to a social security scheme.

8. Patient reachable by phone.

Exclusion Criteria:

1. Patient under guardianship, curatorship or safeguard of justice.

2. Patient with severe mental retardation impairing comprehension abilities.

3. Impossibility of submitting to the medical follow-up of the test.

4. If hospitalized at the time of inclusion: hospitalization forecast greater than 1 week.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Other:
• managment of oral therapy
Initial consultation with a trio oncologist / pharmacist / nurse

Locations

Country	Name	City	State
France	Centre Georges François Leclerc	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of side effects	Side effects evaluated: digestive, cutaneous and mucosal grade 3 and 4	6 months