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

July 20, 2018 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with metastatic cancer or hematological malignancy being treated with oral therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
Patients using the device
Other: CAPRI
Control
Patients not using the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative dose intensity
Time Frame: 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"
Assessed every 30 days from randomization up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: Assessed every 30 days from randomization up to 6 months
Compliance will be assessed using Morisky questionnaire
Assessed every 30 days from randomization up to 6 months
Toxicity
Time Frame: Assessed every 30 days from randomization up to 6 months
Grade 3 or 4 using NCICTCAE version 4.0
Assessed every 30 days from randomization up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 20, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00254-47
  • 2016/2371 (Other Identifier: CSET Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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