Skip to content

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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03300310
Acronym
IPIO-PA
Enrollment
61
Registered
2017-10-03
Start date
2017-11-15
Completion date
2020-07-03
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology, Gerontology

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.

Interventions

OTHERnursing visit

nursing visit at patient home

OTHERno nursing visit

the patient take his treatment without nursing visit

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Comparison of the patient's perception of observance to anticancer therapy3 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 professionals3 months
Determination of the percentage of patients able to be included in the study compared to the number of patients who received an oncogeriatric assessment3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026