Clinical trial NCT04960735: Implementation, Effectiveness and Impact of a Value Based Intervention for Patients with Breast or Lung Cancer
Official title: Value-based Healthcare for Outcomes in Breast and Lung Cancer in Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Keywords: Value-Based Healthcare
Breast Cancer
Lung Cancer
Patient Health Outcomes
Patient's perspective
Patient Reported Outcomes Measures (PROMs)
Patient Reported Experience Measures (PREMs)
Patient quality of life
Healthcare process
Cost analyses
Lead sponsor: Biosistemak Institute for Health Systems Research
Sponsor class: OTHER
Collaborators: name: Hospital de Cruces
name: Hospital Donostia
name: Hospital Universitario 12 de Octubre
name: Complejo Hospitalario de Especialidades Juan Ramón Jimenez
name: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
name: Instituto Portugues de Oncologia, Francisco Gentil, Porto
name: Onze Lieve Vrouwziekenhuis Aalst
name: UNICANCER
First posted: 2021-07-14
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group intervention that will collect health-related Quality of Life evidence from patients with cancer from 13 hospitals for six months. The multicentre study combines an implementation research component and effectiveness, using quantitative and qualitative methods for data collection and analysis. Outcomes will be analysed not only at individual level but also at health organisation level.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: VOICE is a Europe-wide Hospital Community pioneering in the assessment of value-based healthcare outcomes related to breast and lung cancer. The VOICE Community members have extended experience in value-based healthcare paradigm as they founded the community in 2018 in continuity with in the All.Can initiative launched by International Consortium for Health Outcome Measurements (ICHOM).

VOICE aims to implement the innovative value based healthcare approach for patients with breast cancer or lung cancer in routine practice to transform care provision and place the patient at the centre of the system. The project will assess the implementation process, the effectiveness of clinical practice and its impact on costs grouped by process for an intervention-based measurement of outcome values for patients with breast or lung cancer. As a result is expected to (i) analyse the effectiveness of an intervention based on measuring outcome values for patients in order to improve patient empowerment, shared decision-making, and physician-patient communication; (ii) assess the impact of an intervention based on measuring outcome values for patients on costs grouped by clinical process, and in the organisation of healthcare by processes and (iii) integrate the measurement of value-based health outcomes in everyday clinical practice for organisations both systematically and long term.

This study duration will be three years and a half.

* Preparation period (July-December 2018): the intervention was defined; the data battery to be collected was designed; the systems required for that purpose were developed; and professionals participating in the study were recruited and trained.
* Intervention period (January 2019-June 2020): all processes set forth were activated; patient recruitment and follow-up, as well as data collection started.
* Analysis and benchmarking period (June 2020-June 2023): data collected will be analysed and outcomes will be compared among organisations participating in the study and corresponding dissemination.

More than 1,000 patients were progressively recruited in 13 pilot sites (European Hospitals) when diagnosed with breast or lung cancer. Patients who met the eligibility criteria described below were invited to take part in the study once diagnosed at the hospital. Medical professionals (gynaecology, oncology, pneumology and thoracic surgery consultants) explained the study and provided the patients with the information sheet and informed consent form.

Recruitment was conducted in the first six months and patients were monitored for at least six months or until death, if that occurred first. Intervention outcomes were monitored at different times: at the start (on recruitment which coincided with diagnosis); at 6 months in breast cancer; and at the start (on recruitment which coincided with diagnosis), at 3 months; and after 6 months in lung cancer.

This multicentre prospective study combines an implementation research component and an effectiveness component, using quantitative and qualitative methods for data collection and analysis. Quantitative analysis includes a descriptive analysis of all variables included in the study. Categorical variables will be shown using frequencies and percentages, n (%). Continuous variables with normal distribution will be shown as standard deviation (SD). Continuous variables with non-normal distribution will be shown as median and first and third quartiles (Q1, Q3). Pre and post intervention differences between categorical variables will be calculated with McNemar's test used on paired data. In continuous variables, the Student´s t test will be used on paired data; or the Wilcoxon rank sum test for variables with normal and non-normal distributions, respectively. Moreover, regression models for the pre/post difference will be proposed to assess whether that difference varies from 0. Models will be adjusted by possible determinant factors such as gender and other socio-demographic elements.

The qualitative analysis to be carried out at the end of the intervention will include semi-structured interviews and focus groups methods. Analyses will be performed at individual level (patient) and at organisational level (costs).

Data management will meet the current European Union (EU) General Data Protection Regulations (GDPR) and shall include detailed information on the procedures in terms of data collection, conservation, protection, reuse and/or destruction. The project will only obtain essential data, and will never share patients' personal data or raw anonymous data. Data obtained will be used for assessment purposes, impact valuation and to increase the empirical base. Templates are based on ICHOM data dictionary for breast cancer and lung cancer where each variable is coded and responses are typified.

VOICE will follow the procedures indicated in the new general data protection regulation No 2016/679 that has been recently applied in Europe for the data access, protection and sharing.

The Community partners have signed an agreement to access and to share data.

Eligibility criteria: Inclusion Criteria for patients with breast cancer:

* male and female over 18
* recently diagnosed with invasive stage I-IV cancer, or Ductal Carcinoma in Situ (DCIS)
* undergoing any treatment type (surgery, radiotherapy, chemotherapy, hormone therapy and/or targeted therapy).

Inclusion Criteria for patients with lung cancer:

* male and female over 18
* newly diagnosed with lung cancer
* eligible to receive curative or palliative care treatment.

Exclusion Criteria for patients with breast cancer:

* With rare tumours
* With Lobular Carcinoma In Situ (LCIS)
* With recurring illness

Primary outcomes:
measure: Change from baseline overall well-being for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.. Lung Cancer patients completed the PROMs questionnaires at baseline, and after three and six months.
measure: Change from baseline Asthenia and fatigue (including physical functioning) at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Emotional functioning (also including anxiety and depression) for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Cognitive functioning for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Social and working functioning (also including financial impact) for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months
measure: Change from baseline Body image for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Sexual functioning for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Satisfaction with breasts for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Arm and breast symptoms for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Adverse effects: vasomotor symptoms for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Adverse effects: peripheral neuropathy for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Adverse effects: Arthralgia for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Vaginal symptoms for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Quality of life for patients with breast cancer at 6 months
timeFrame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Global health status / Quality of life for patients with Lung Cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Fatigue for patients with lung cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Social function for patients with lung cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Physical functioning for patients with Lung Cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Emotional functioning for patients with lung cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Cognitive function for patients with Lung Cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Pain for patients with lung cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Shortness of breath for patients with Lung Cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
measure: Change from baseline Cough for patients with lung cancer at 6 months
timeFrame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six months.
Secondary outcomes:
measure: Rate of survival of patients with Breast Cancer
timeFrame: For Breast cancer patients, during the intervention: at baseline and at six months.
measure: Rate of survival of patients with Lung Cancer
timeFrame: For Breast cancer patients, during the intervention: at baseline, and at three and at six months.
measure: Number of patients suffering serious treatment-related complications due to care of treatment for breast cancer
timeFrame: For Breast cancer patients, during the intervention: at six months since the diagnostic.
measure: Number of patients suffering serious treatment-related complications due to care of treatment for lung cancer
timeFrame: For Lung Cancer patients, during the intervention: at six months since the diagnostic.
measure: Average total cost per patient with breast cancer
timeFrame: For Breast cancer patients, during the intervention at 12 months period since the diagnostic
measure: Average total cost per patient with lung cancer
timeFrame: For Lung cancer patients, during the intervention at 12 months period since the diagnostic
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Olv Aalst
state: Flandes
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest
state: Maine et Loira
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
state: Forlì-Cesena
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto
city: San Sebastián
country: Spain
facility: Donostia University Hospital
state: Gipuzkoa
city: Barakaldo
country: Spain
facility: Cruces University Hospital
state: Vizcaya
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Madrid
country: Spain
facility: 12 Octubre University Hospital
Study officials:
affiliation: Biosistemak (formerly Kronikgune)
name: Ane Fullaondo, Ph.D.
role: STUDY_CHAIR
References:
citation: Garcia-Lorenzo B, Gorostiza A, Alayo I, Castelo Zas S, Cobos Baena P, Gallego Camina I, Izaguirre Narbaiza B, Mallabiabarrena G, Ustarroz-Aguirre I, Rigabert A, Balzi W, Maltoni R, Massa I, Alvarez Lopez I, Arevalo Lobera S, Esteban M, Fernandez Calleja M, Gomez Mediavilla J, Fernandez M, Del Oro Hitar M, Ortega Torres MDC, Sanz Ferrandez MC, Manso Sanchez L, Serrano Balazote P, Varela Rodriguez C, Campone M, Le Lann S, Vercauter P, Tournoy K, Borges M, Oliveira AS, Soares M, Fullaondo A; VOICE Study Group. European value-based healthcare benchmarking: moving from theory to practice. Eur J Public Health. 2024 Feb 5;34(1):44-51. doi: 10.1093/eurpub/ckad181.
citation: Garcia-Lorenzo B, Alayo I, Arrospide A, Gorostiza A, Fullaondo A; VOICE Study Group. Disentangling the value equation: a step forward in value-based healthcare. Eur J Public Health. 2024 Aug 1;34(4):632-638. doi: 10.1093/eurpub/ckae060.