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

Metastatic Cancer Clinical Trial

— CAPRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02828462
• Other study ID #: 2016-A00254-47
• Secondary ID: 2016/2371
• Status: Recruiting
• Start date: October 24, 2016
• Est. completion date: October 2020

Study information

• Verified date: July 2018
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Marie Ferrua
• Phone: 0142116148
• Email: marie.ferrua[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematological Malignancy
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Other:
• CAPRI

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative dose intensity	RDI will be calculated as follow "delivered dose intensity/dose intensity of the standard tumor regimen"	Assessed every 30 days from randomization up to 6 months
Secondary	Compliance	Compliance will be assessed using Morisky questionnaire	Assessed every 30 days from randomization up to 6 months
Secondary	Toxicity	Grade 3 or 4 using NCICTCAE version 4.0	Assessed every 30 days from randomization up to 6 months