Optimizing the Management of Patients With Oral Therapy

NCT ID: NCT03623490

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2021-05-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

accented follow-up

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.

Group Type: EXPERIMENTAL

managment of oral therapy

Intervention Type: OTHER

Initial consultation with a trio oncologist / pharmacist / nurse

standard follow-up

Initial consultation with the oncologist and follow-up visit with the oncologist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

managment of oral therapy

Initial consultation with a trio oncologist / pharmacist / nurse

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Georges François Leclerc

Dijon, , France

Countries

France

Other Identifiers

IPAC

Identifier Type: -

Identifier Source: org_study_id