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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Oncology, Gerontology

Treatments: Other: no nursing visit; Other: nursing visit

Study type: Interventional

Funder types: Other

Identifiers

NCT03300310

RC17_0096

2017-A00629-44 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

61 participants in 2 patient groups

with nursing visit

Experimental group

Description:

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

Treatment:

Other: nursing visit

without nursing visit

Experimental group

Description:

no nursing visit

Treatment:

Other: no nursing visit