NCT05650814

Brief Summary

The primary goal of this non-profit single-centre randomized pilot interventional study is to evaluate the acceptability of a daily telemonitoring of five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) using a medical device in advanced cancer patients with relevant cardiovascular and respiratory comorbidities assisted at home. In addition to the standard home care, participants in the intervention group will keep the medical device at home. They will register five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) once a day for eight weeks. Participants belonging to the control group will receive standard home care. The secondary goals of this study include the following:

  • Analyzing the effect of telemonitoring on patients' quality of life and psychological status.
  • Observing the possible effects of telemonitoring on the caregiver care burden.
  • Assessing the possible effects of telemonitoring on the caregiver perceived satisfaction with the home care received.
  • Comparing the number of physician and nurse home visits and phone calls between the patients using the device and patients in standard home care.
  • Comparing the number of emergency room visits, admissions, and hospitalization days between the patients using the device and patients in standard home care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2024

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

November 30, 2022

Last Update Submit

December 19, 2022

Conditions

CancerCardiovascular DiseasesRespiratory Disease

Keywords

CancerHome careTelemedicineTelemonitoringPalliative careQuality of life

Outcome Measures

Primary Outcomes (2)

  • Acceptability

    Percentage of eligible patients proposed for the study who agree to participate.

    8 weeks

  • Number of measurements

    Number of measurements/week per patient.

    8 weeks

Secondary Outcomes (5)

  • Quality of life

    Day 1, day 28 and day 56

  • Perceived health status

    Day 1, day 28 and day 56

  • Psychological status

    Day 1, day 28 and day 56

  • Caregiver burden

    Day 1, day 28 and day 56

  • Satisfaction with care

    Day 56

Study Arms (2)

ButterfLife

EXPERIMENTAL

The patient will be recommended to take the measurement of five vital parameters once a day by ButterfLife device. Daily telemonitoring will be conducted in addition to standard home care.

Device: ButterfLife

Control

OTHER

The patients will receive standard home care.

Other: Control

Interventions

ButterfLifeDEVICE

On day 1, the investigator delivers the ButterfLife device at home and explains its use. The patient is recommended to take the measurement once a day, preferably in the morning and to repeat the measurement of parameters during the day if necessary. The doctor will check the data recorded by the patient every day and the trend of the parameters over time by a graphical representation on the electronic medical record (Vitaever®, Nethical S.r.l.). Daily telemonitoring will be conducted in addition to standard home care.

ButterfLife
ControlOTHER

Patients will receive standard home care: visits will be planned according to the patient's needs. In case of an unstable clinical condition, worsening of symptoms, and alteration of vital parameters, patient can contact by phone the physician or the nurse, who will decide how to intervene.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced cancer assisted at home;
  • Age ≥ 18 years;
  • Able to understand the objectives of the study and sign the informed consent;
  • Able to speak and understand the Italian language;
  • KPS ≥ 50;
  • Presence of at least one of the following comorbidities:
  • Chronic Obstructive Pulmonary Disease (COPD);
  • Chronic ischaemic heart disease (CIC) after acute myocardial infarction (AMI)
  • Pulmonary emphysema;
  • Valvulopathy;
  • Systemic arterial hypertension;
  • Severe coronary artery disease;
  • Respiratory failure related to primary or metastatic lung cancer disease;
  • Cardiomyopathy developed after oncological treatment. This symptomatology may be directly related to the oncological disease or independent of it (pre-existing pathology at the time of cancer diagnosis, symptoms occurring as a result of oncological therapies, age-related onset).
  • The severity of these comorbidities must be relevant to the patient's clinical profile expressed in at least one of the following conditions:
  • +3 more criteria

You may not qualify if:

  • Patients with a diagnosis of dementia or cognitive impairment hampering the comprehension of the study information and/or signing of informed consent,
  • Patients who are dying.
  • Patients refusing to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione ANT Italia ONLUS

Bologna, BO, 40128, Italy

RECRUITING

MeSH Terms

Conditions

NeoplasmsCardiovascular DiseasesRespiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Italo Malavasi

    Fondazione ANT Italia ONLUS

    PRINCIPAL INVESTIGATOR

  • Guido Biasco

    University of Bologna

    STUDY DIRECTOR

  • Anna Vittoria Mattioli

    University of Modena e Reggio Emilia

    STUDY CHAIR

Central Study Contacts

Rita Ostan

CONTACT

+393487900191rita.ostan@ant.it

Andrea Giannelli

CONTACT

+393475225352andrea.giannelli@ant.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 14, 2022

Study Start

May 23, 2022

Primary Completion

November 23, 2023

Study Completion

May 23, 2024

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)