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

Study Overview
=================
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.

Official Title
-----------------
Value-based Healthcare for Outcomes In Breast and Lung Cancer in Europe

Conditions
-----------------
Breast Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Other: VOICE intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with cancer (patients with breast cancer and patients with lung cancer)<br>Health-related Quality of Life evidence was collected from patients with cancer (patients with breast cancer and patients with lung cancer) for six months. The evidence was collected by means of health related and patient reported questionnaires (ICHOM standard sets for breast cancer and lung cancer). Patients were monitored for six months. Intervention outcomes were monitored at different times: for patients with breast cancer, at the start (on recruitment which coincided with diagnosis) and at six months; for patients with lung cancer, at the start (on recruitment which coincided with diagnosis), at three and at six months. | Other: VOICE intervention<br>* 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, Model construction: Based on the process mapping and on root cause analysis, the multidisciplinary team designs the new care pathway. Professionals are trained in those tasks allocated according to the new care process.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline overall well-being for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | 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. | 
| Change from baseline Asthenia and fatigue (including physical functioning) at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Emotional functioning (also including anxiety and depression) for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Cognitive functioning for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Social and working functioning (also including financial impact) for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months | 
| Change from baseline Body image for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---BR23 (BR23: Breast Cancer Module). | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Sexual functioning for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---BR23 (BR23: Breast Cancer Module). | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Satisfaction with breasts for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire BREAST---Q ---Satisfaction with Breast (The BREAST-Q © is a multiscale, multimodule, patient-reported outcome instrument (PRO) measuring health-related quality of life and patient satisfaction in women who undergo breast surgery.Domain Patient satisfaction: Satisfaction with breasts). | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Arm and breast symptoms for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---BR23 (BR23: Breast Cancer Module). | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Adverse effects: vasomotor symptoms for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---BR23 (BR23: Breast Cancer Module). | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Adverse effects: peripheral neuropathy for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---LMC21 (questionnaire for assessment of patient-reported outcomes during treatment of colorectal liver metastases) -- single item. | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Adverse effects: Arthralgia for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaires EORTC QLQ---BR23, EORTC QLQ---LMC21 -- (questionnaire for assessment of patient-reported outcomes during treatment of colorectal liver metastases) single item and FACT (Functional Assessment of Cancer Therapy) -- ES (Endocrine Subscale) (single item). | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Vaginal symptoms for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire FACT (Functional Assessment of Cancer Therapy) -- ES (Endocrine Subscale) (single item). | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Quality of life for patients with breast cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the standardised measure EQ-5D (5D: Dimensions) (EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys) for the measurement of health-related quality of life. EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. On the scale, a value of 100 indicates the best imaginable state of health while a value of 0 the worst imaginable state of health. | Breast Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Global health status / Quality of life for patients with Lung Cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Fatigue for patients with lung cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Social function for patients with lung cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Physical functioning for patients with Lung Cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Emotional functioning for patients with lung cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Cognitive function for patients with Lung Cancer at 6 months | Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC (European Organization for Research and Treatment of Cancer) QLQ (quality of life questionnaire) -- C30. | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Pain for patients with lung cancer at 6 months | Outcome measure reported by patients with lung cancer by means of completion of the questionnaires EORTC QLQ---C30 and EORT QLQ-LC13 (a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials). | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Shortness of breath for patients with Lung Cancer at 6 months | Outcome measure reported by patients with lung cancer by means of completion of the questionnaire EORT QLQ-LC13 (a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials). | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 
| Change from baseline Cough for patients with lung cancer at 6 months | Outcome measure reported by patients with lung cancer by means of completion of the questionnaire EORT QLQ-LC13 (a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials). | Lung Cancer patients completed the PROMs questionnaires at baseline and after six months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of survival of patients with Breast Cancer | Percentage of patients alive after completion of the study For Lung Cancer: Overall survival, Cause of death, Quality of death. | For Breast cancer patients, during the intervention: at baseline and at six months. | 
| Death attributed to breast cancer | Percentage of deceased patients whose death is attributed to breast cancer | For Breast cancer patients, during the intervention: at baseline and at six months. | 
| Rate of survival of patients with Lung Cancer | Percentage of patients alive after completion of the study | For Breast cancer patients, during the intervention: at baseline, and at three and at six months. | 
| Death attributed to lung cancer | Percentage of deceased patients whose death is attributed to breast cancer For Lung Cancer patients: Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) performance status | For Lung Cancer patients, during the intervention: at baseline and at three and at six months. | 
| Time to recovery of patients with Breast Cancer | Recurrence free survival | For Breast cancer patients, during the intervention: at baseline and at six months | 
| Number of patients suffering disutility due to care of treatment | For Breast Cancer: Number of patients reoperated, Number of patients suffering acute complications. For Lung Cancer: Treatment-related mortality, Number of patients with major surgical complications, Number of patients with major radiation complications, Number of patients with major systemic therapy complications | For Breast cancer patients, during the intervention: at baseline and at six months. For Lung Cancer patients, during the intervention: at baseline and at three and at six months | 
| Recurrence in patients with Breast Cancer | Percentage of patients with recurrence | For Breast cancer patients, during the intervention: at baseline and at six months. | 
| Sustainability recovery of patients with lung cancer | Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) performance status. This scale ranges from 0 to 5, where the higher values means a worse outcome (5 means the patient is dead) | For Lung Cancer patients, during the intervention: at baseline and at three and at six months. | 
| Overall perception of participants (patients and professionals) after the Intervention | This Overall perception outcome measure will be assessed from the point of view of the main actors involved (patients and professionals) detailing their experience with the intervention. It will be analysed by qualitative techniques at the end of the intervention and it will include semi-structured interviews (for professionals) and focus groups (for patients) methods. The qualitative evaluation will be held in person or online/telephonically, depending on the measures and recommendations in force due to Covid-19, or according to the preferences of the participants. The main variables to assess overall perception with qualitative analyses will be: For patients: Quality of life, Relationship with professionals, Acceptability of the intervention by patients, Decision-making process. For Clinicians: Satisfaction with the intervention, Intervention acceptability in professionals' routine practice, Barriers and facilitators of the implementation process, Decision-making process. | Up to 1 year after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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