Clinical trial NCT03300310: Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment in the Elderly
Official title: Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oncology, Gerontology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 61
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: Comparison of the patient's perception of observance to anticancer therapy
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
measure: Assessment of patients' satisfaction (of the arm with passage of the nurse) and the professionals
timeFrame: 3 months
measure: Determination of the percentage of patients able to be included in the study compared to the number of patients who received an oncogeriatric assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Angers
country: France
facility: ICO Angers
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Hôpital privé du Confluent
city: Saint Nazaire
country: France
facility: CH Saint Nazaire
city: St Herblain
country: France
facility: ICO Nantes
Study officials:
References: