Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment in the Elderly (IPIO-PA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Oncology, Gerontology
• Intervention / Treatment: Other: nursing visit; Other: no nursing visit

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • ICO Angers
  • La Roche-sur-Yon, France, 85000
    • CHD Vendee
  • Nantes, France, 44000
    • CHU de Nantes
  • Nantes, France, 44200
    • Hôpital Privé du Confluent
  • Saint Nazaire, France, 44 606
    • CH Saint Nazaire
  • St Herblain, France, 44805
    • ICO Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): July 3, 2020
• Study Completion (Actual): July 3, 2020

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RC17_0096; 2017-A00629-44 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No