Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment in the Elderly

Study Overview
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Brief Summary
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The increasingly used oral anticancer treatments allow the patient to reduce treatment and social constraints to reduce hospitalization costs. The counterpart is a decrease in the monitoring of the correct intake of drugs and the detection of side effects. These two risks are major in the elderly, due to comorbidities, poly-medication and decreased attention. The project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes for 3 months, compared to a conventional management without a nursing visit. It is a prospective, randomized, controlled, multicenter study to include 224 patients over 18 months. The impact will be assessed by counting the tablets not taken and by filling an observation booklet with the nurse at home.

Official Title
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Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment

Conditions
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Oncology, Gerontology

Intervention / Treatment
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* Other: nursing visit
* Other: no nursing visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 70 and over Patient initiating an oral anticancer treatment (Chemotherapy, Targeted therapy, 2nd generation hormone therapy type Acetate abiraterone and Enzalutamide) Patient who received an onco-geriatric assessment Patient with informed consent signed Exclusion Criteria: Patient in a medical institution Patient under exclusive hormone therapy Patient already eligible for nurse support Patient not speaking French Patient under tutelage and guardianship or under safeguard of justice Patient already included in a research protocol Patient sharing his or her home with a person receiving nursing care at home more than once a week and for a period longer than 1 month after the patient's inclusion.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with nursing visit<br>a nurse visit is scheduled twice a week during 3 months at patient home. | Other: nursing visit<br>* nursing visit at patient home<br>|
| Experimental: without nursing visit<br>no nursing visit | Other: no nursing visit<br>* the patient take his treatment without nursing visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison, at 3 months after the oncological treatments began, of the observance rate of the anticancer drugs (corresponding to the entire carcinological protocol) with or without passage of a nurse at the patient's home. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the patient's perception of observance to anticancer therapy |  | 3 months | 
| Comparison of causes of possible premature and definitive cessation of cancer treatments 3 months after the start of treatment and changes in treatment (dose, rhythm of cycles) |  | 3 months | 
| Assessment of patients' satisfaction (of the arm with passage of the nurse) and the professionals |  | 3 months | 
| Determination of the percentage of patients able to be included in the study compared to the number of patients who received an oncogeriatric assessment |  | 3 months |