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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2020-07-03

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.

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Detailed Description

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Conditions

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Oncology, Gerontology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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with nursing visit

a nurse visit is scheduled twice a week during 3 months at patient home.

Group Type EXPERIMENTAL

nursing visit

Intervention Type OTHER

nursing visit at patient home

without nursing visit

no nursing visit

Group Type EXPERIMENTAL

no nursing visit

Intervention Type OTHER

the patient take his treatment without nursing visit

Interventions

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nursing visit

nursing visit at patient home

Intervention Type OTHER

no nursing visit

the patient take his treatment without nursing visit

Intervention Type OTHER

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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No