NeoplasmsIsereADOMNCT03330730

Evaluation of the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer

A study testing IsereADOM service package in people with Neoplasms, run by Centre Leon Berard at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of the project is to compare the effectiveness and efficiency of innovative care through the IsereADOM home-care service package versus standard care in the prevention of unplanned hospitalizations in patients with cancer treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: IsereADOM service package
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 3 sitesFrance
Study dates: 11 Jan 2018to 17 Jun 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age > or = 18 years old at the time of signature of informed consent form
patient with solid or hematologic tumor under treatment for cancer at the time of inclusion
Patient managed in a medical emergency context in the 2 weeks prior to inclusion
Patient living in Isère department (area of coverage of experiment)
ECOG Performance index < or = 3
patient with a life expectancy of 6 months or more

Show all 9Show fewer

patient with social security system
patient able to read, write and understand French
patient with signed informed consent

Who cannot join

Patient included in clinical trial evaluating early stage therapeutic innovation with pharmacokinetic sampling
Patients with follow-up in Hospitalization at Home at the end of the hospitalization for inclusion
Patient without help "referent" in the entourage (spouse, family, friend ...)
Patient residing in Elderly Accommodation (EHPAD) or in any other institution for dependent persons
Patient who is homeless or living in a home that does not allow the installation of the necessary equipment
Patient with severe cognitive impairment, defined by score at Mini Mental State Examination (MMSE)< 23/30
Patient unable to comply (or unwilling to comply) with follow-up of the study for the duration of participation

Trial locations and contacts

3 sites in 1 country.

France3 sites

CHU Grenoble Alpes
Grenoble
Institut Daniel Hollard
Grenoble
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, 69008

Other trials in France

About this study

Official title: A Randomized, Controlled, Multicenter, Prospective, Open Study Evaluating the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer

Read the detailed description

Specific management of cancer patients involves carrying out often heavy treatments (surgery, chemotherapy, radiotherapy, interventional radiology, etc.) during which close coaching is necessary. In spite of this adapted follow-up, the natural evolution of the disease and the management of treatment tolerance make these patients a frail population, sometimes isolated, for which admission to emergency services and admission to full hospitalization can be required.

This trial will use a service package at home named IsereADOM, currently in the development phase in the management of 4 types of populations:

Retired persons with no proven loss of autonomy;
Users with loss of autonomy at risk of falling;
Cardiac insufficiency;
Patients with cancer.

This service package is based on the identification of a person of proximity, called "sentinel referent". This person, in charge of monitoring the patient at his / her home, has access to various connected tools installed at the patient's home (scales, tensiometer ...) as well as computer solutions enabling the sharing of information with the different actors in the management of the patient.

In addition, the patient benefits from motivational coaching based on investigator's recommendation and telephone and internet information platforms.

Conditions: Neoplasms
Being tested: IsereADOM service package
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IsereADOM service packageOther
Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching

Study groups in NCT03330730
Study group	Role	What they receive
Experimental	Experimental	Patients with oncological follow up and home-care service package IsereADOM: Objects connected to patients' home (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer) with graduated protocol for medical platform support. Digital linkbook (different from the medical file) accessible to the patient and the standard care actors. Referent sentinel: a field actor to coordinate the care. Preferred contact of the patient outside the center Motivational coaching: 1 to 2 axes to be defined by the investigator among the following axes (physical activity, nutrition and hydration, drug compliance, medical follow-up, chronic and moral pain, acceptance of the disease and treatments). Receives: Other: IsereADOM service package
Control	No intervention	Patients with oncological follow up only

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of the effectiveness and efficiency of innovative care with the IsereADOM home-care service package versus standard support
Comparison of the mean number of unplanned hospitalizations observed within 6 months of randomization.
Measured: 6 months
Incremental Cost-Utility Ratio comparison
Evaluation of the costs of the home-care service package; Assessment of health care consumption from a community perspective; Calculation of the years of life gained in good health (QALY)
Measured: 6 months

Secondary outcomes (19)

Budget impact analysis
Calculation of incremental costs and saved costs with the experimental strategy
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of loss of autonomy with questionnaires "Activities of Daily Living"
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of loss of autonomy with questionnaires "Instrumental Activities of Daily Living"
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of anxiety with questionnaire "Hospital Anxiety and Depression scale"
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of depression with questionnaire "Hospital Anxiety and Depression scale"
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of nutritional status by measuring albumin rate
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of nutritional status by measuring prealbumin rate
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of nutritional status by measuring weight
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of the quality of life with questionnaire "EuroQoL 5 Dimensions 5 Levels"
Measured: 6 months
Patient's condition evaluation
Description in both arms of home care with questionnaire "RUD" for the natural caregivers
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of consumption of unprogrammed care with patient's booklet
Measured: 6 months
Patient's condition evaluation
Evaluation in both arms of overall survival
Measured: 6 months
Patient's condition evaluation
Characterizing unjustified hospitalizations, to determine predictive factors for the efficiency of experimental management, progression-Free Survival
Measured: 6 months
Evaluation of IsereADOM home-care service package impact
Evaluation of the duration of setting up the experimental procedure by measuring the delay between the randomisation and the complete installation of the home-care service package at the patient's home
Measured: 6 months
Evaluation of IsereADOM home-care service package impact
Evaluation of the proportion of sentinel nurses asked to participate in the study
Measured: 6 months
Evaluation of IsereADOM home-care service package impact
Evaluation of the number of calls and the number of connections to the telephone and Internet platforms
Measured: 6 months
Evaluation of IsereADOM home-care service package impact
Evaluation of the number of refusal to participate.
Measured: 6 months
Evaluation of IsereADOM home-care service package impact
Evaluation of the causes of refusal to participate.
Measured: 6 months
Analysis of the geographical factors predicting the effectiveness of the package
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 201817 Jun 2019

First posted6 Nov 2017
Study start11 Jan 2018
Primary completion17 Jun 2019
Study completion17 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Centre Leon BerardThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03330730
Sponsor's protocol ID: IsereADOM
Acronym: IsereADOM
Status last verified: Dec 2019
First submitted: 25 Oct 2017
Last updated: 13 Dec 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Multicenter, Prospective, Open Study Evaluating the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer
ClinicalTrials.gov ID: NCT03330730
Acronym / sponsor ID: IsereADOM / IsereADOM
Conditions: Neoplasms
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Centre Leon BerardUniversity, hospital or other
Collaborators: Conseil general de l'Isere
Study start: 11 Jan 2018 (actual)
Primary completion: 17 Jun 2019 (actual)
Study completion: 17 Jun 2019 (actual)
First posted: 6 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This trial will use a service package at home named IsereADOM, currently in the development phase in the management of 4 types of populations:

Retired persons with no proven loss of autonomy;
Users with loss of autonomy at risk of falling;
Cardiac insufficiency;
Patients with cancer.

In addition, the patient benefits from motivational coaching based on investigator's recommendation and telephone and internet information platforms.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental	Experimental	Other: IsereADOM service packagePatients with oncological follow up and home-care service package IsereADOM: Objects connected to patients' home (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer) with graduated protocol for medical platform support. Digital linkbook (different from the medical file) accessible to the patient and the standard care actors. Referent sentinel: a field actor to coordinate the care. Preferred contact of the patient outside the center Motivational coaching: 1 to 2 axes to be defined by the investigator among the following axes (physical activity, nutrition and hydration, drug compliance, medical follow-up, chronic and moral pain, acceptance of the disease and treatments).
Control	No intervention	–Patients with oncological follow up only

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

age > or = 18 years old at the time of signature of informed consent form
patient with solid or hematologic tumor under treatment for cancer at the time of inclusion
Patient managed in a medical emergency context in the 2 weeks prior to inclusion
Patient living in Isère department (area of coverage of experiment)
ECOG Performance index < or = 3

Key exclusion criteria (7 listed)

Patient included in clinical trial evaluating early stage therapeutic innovation with pharmacokinetic sampling
Patients with follow-up in Hospitalization at Home at the end of the hospitalization for inclusion
Patient without help "referent" in the entourage (spouse, family, friend ...)
Patient residing in Elderly Accommodation (EHPAD) or in any other institution for dependent persons
Patient who is homeless or living in a home that does not allow the installation of the necessary equipment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IsereADOM service packageObjects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching	Other	Experimental

Primary outcome

Comparison of the effectiveness and efficiency of innovative care with the IsereADOM home-care service package versus standard support
Time frame: 6 months
Comparison of the mean number of unplanned hospitalizations observed within 6 months of randomization.
Incremental Cost-Utility Ratio comparison
Time frame: 6 months
Evaluation of the costs of the home-care service package; Assessment of health care consumption from a community perspective; Calculation of the years of life gained in good health (QALY)

19 secondary outcomes

Budget impact analysis
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Patient's condition evaluation
Time frame: 6 months
Evaluation of IsereADOM home-care service package impact
Time frame: 6 months
Evaluation of IsereADOM home-care service package impact
Time frame: 6 months
Evaluation of IsereADOM home-care service package impact
Time frame: 6 months
Evaluation of IsereADOM home-care service package impact
Time frame: 6 months
Evaluation of IsereADOM home-care service package impact
Time frame: 6 months
Analysis of the geographical factors predicting the effectiveness of the package
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.

Related trials for Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IsereADOM service package in people with Neoplasms, run by Centre Leon Berard at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the effectiveness and efficiency of innovative care with the IsereADOM home-care service package versus standard support (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03330730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.