Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics

• Conditions: Hematological Malignancy; Metastatic Cancer
• Interventions: Other: CAPRI

• Registration Number: NCT02828462
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program's potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact.

The investigators are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including toxic side effects, patient quality of life and patient experience . An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health care resources' used. A parallel process evaluation will be conducted to describe implementation of the intervention

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Study Start: 2016-10-24
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-23
• Primary Completion: 2019-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients (male or female) aged > 18 years
• Life expectancy > 6 months
• Patients with tumour or hematological malignancy being treated at Gustave Roussy
• Patients with oral therapy (cytotoxic or targeted therapies)
• Patients starting therapy
• Patients living in France
• Patients affiliated to a social security system or equivalent
• OMS score from 0 to 2 at the time of inclusion
• Signed inform consent
• Patients able to follow protocol

Exclusion Criteria

• Patients being treated with hormonotherapy only
• Patients enrolled in a clinical trial ongoing treatment with an experimental compound except in the case where the sponsor agrees that the CAPRI protocol is not intefering with the trial
• Not French speaking patients
• Patients deprived of liberty
• Patients with no internet access or telephone line

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	CAPRI	Patients using the device

Primary Outcome Measures

Name	Time	Method
Relative dose intensity	Assessed every 30 days from randomization up to 6 months	RDI will be calculated as follow "delivered dose intensity/dose intensity of the standard tumor regimen"

Secondary Outcome Measures

Name	Time	Method
Toxicity	Assessed every 30 days from randomization up to 6 months	Grade 3 or 4 using NCICTCAE version 4.0
Compliance	Assessed every 30 days from randomization up to 6 months	Compliance will be assessed using Morisky questionnaire

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France