Implementation, Effectiveness and Impact of a Value Based Intervention for Patients with Breast or Lung Cancer

NCT04960735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1007

Last updated 2025-03-10

No results posted yet for this study

Summary

VOICE project aims to guide health services in their reorganization towards the provision of the highest value care for the patient at the best cost. VOICE is targeted to patients with breast and lung cancer. The purpose is to offer a new innovative strategic framework based on value-based healthcare model to these patients in Europe. VOICE Community consists of 13 hospitals across Europe working collaboratively to implement this approach.

The Community addresses what matters most to patients by measuring patient reported health outcomes in routine clinical practice on a systematic and long-term basis, by including patients´ perspective in clinical decision-making, improving patient empowerment and physician-patient communication, assessing the impact on costs of the processes implemented, identifying factors for a successful implementation of value-based healthcare and boosting knowledge generation and best practice exchange across Europe.

The VOICE ambition is to collect the health-related Quality of Life evidence from more than 1000 patients (patients with breast cancer and patients with lung cancer), by means of health related and patient reported questionnaires (ICHOM, International Consortium for Health Outcome Measurements, standard sets). Hospitals will go further by assessing the satisfaction, acceptability, relationship with professionals or decision-making process with patients.

The VOICE Community will benchmark health outcomes and related costs to improve care delivery of these patients.

Conditions

Interventions

OTHER

VOICE intervention

The intervention consists of four stages: * S1, Value identification and description of current care processes: Needs are detected from two perspectives: feedback from patients and mapping of healthcare processes. ICHOM questionnaires are reviewed. Patient surveys and clinical forms are developed. The methodology for cost analysis is set up. * S2, Intervention implementation: Patients are recruited according to the eligibility criteria. Their care follows the current healthcare pathway and information is collected at different time points. * S3, Assessment of outcomes and continued benchmarking: Data and costs are analysed at both local level and Community level (benchmarking). Interviews and focus groups are held (optional). Root cause analysis is performed. * S4, Best practice sharing: Identifying what lessons could be learned from the best-performing sites, according to the results of the VOICE community benchmarking and following qualitative techniques.

Sponsors & Collaborators

  • Hospital de Cruces

    collaborator OTHER
  • Hospital Donostia

    collaborator OTHER
  • Hospital Universitario 12 de Octubre

    collaborator OTHER
  • Complejo Hospitalario de Especialidades Juan Ramón Jimenez

    collaborator OTHER
  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    collaborator OTHER
  • Instituto Portugues de Oncologia, Francisco Gentil, Porto

    collaborator OTHER
  • Onze Lieve Vrouwziekenhuis Aalst

    collaborator OTHER
  • UNICANCER

    collaborator OTHER
  • Biosistemak Institute for Health Systems Research

    lead OTHER

Principal Investigators

  • Ane Fullaondo, Ph.D. · Biosistemak (formerly Kronikgune)

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-12-31
Completion
2023-03-30

Countries

  • Belgium
  • France
  • Italy
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04960735 on ClinicalTrials.gov