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

Not Applicable

Terminated

• Conditions: Oncology, Gerontology
• Interventions: Other: nursing visit; Other: no nursing visit

• Registration Number: NCT03300310
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-03
• Study Start: 2017-11-15
• Primary Completion: 2020-07-03
• Study Completion: 2020-07-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with nursing visit	nursing visit	a nurse visit is scheduled twice a week during 3 months at patient home.
without nursing visit	no nursing visit	no nursing visit

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Comparison of the patient's perception of observance to anticancer therapy	3 months
Assessment of patients' satisfaction (of the arm with passage of the nurse) and the professionals	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
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

Trial Locations

Locations (6)

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

ICO Angers; 🇫🇷 Angers, France

CH Saint Nazaire; 🇫🇷 Saint Nazaire, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital privé du Confluent; 🇫🇷 Nantes, France

ICO Nantes; 🇫🇷 St Herblain, France