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

NCT04960735 | Completed

• 1 other identifier: INT/2020/VOICE
• Study Type: interventional
• Target: 1,007
• Locations: 5 countries
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (23)

• 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 Outcomes (6)

• Rate of survival of patients with Breast Cancer

  For Breast cancer patients, during the intervention: at baseline and at six months.

• Rate of survival of patients with Lung Cancer

  For Breast cancer patients, during the intervention: at baseline, and at three and at six months.

• Number of patients suffering serious treatment-related complications due to care of treatment for breast cancer

  For Breast cancer patients, during the intervention: at six months since the diagnostic.

• Number of patients suffering serious treatment-related complications due to care of treatment for lung cancer

  For Lung Cancer patients, during the intervention: at six months since the diagnostic.

• Average total cost per patient with breast cancer

  For Breast cancer patients, during the intervention at 12 months period since the diagnostic

Study Arms (1)

Patients with cancer (patients with breast cancer and patients with lung cancer)

EXPERIMENTAL

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

Interventions

VOICE intervention OTHER

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.

Patients with cancer (patients with breast cancer and patients with lung cancer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Biosistemak Institute for Health Systems Research: lead
• Hospital de Cruces: collaborator
• Hospital Donostia: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Complejo Hospitalario de Especialidades Juan Ramón Jimenez: collaborator
• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: collaborator
• Instituto Portugues de Oncologia, Francisco Gentil, Porto: collaborator
• Onze Lieve Vrouwziekenhuis Aalst: collaborator
• UNICANCER: collaborator

Study Sites (8)

Olv Aalst

Aalst, Flanders, B-9300, Belgium

Location

Institut de Cancerologie de l'Ouest

Angers, Maine Et Loira, 49 055, France

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Forlì-Cesena, 47014, Italy

Location

Instituto Português de Oncologia do Porto

Porto, 4200-072, Portugal

Location

Donostia University Hospital

San Sebastián, Gipuzkoa, 20014, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, Huelva, 21005, Spain

Location

12 Octubre University Hospital

Madrid, Madrid, 28041, Spain

Location

Cruces University Hospital

Barakaldo, Vizcaya, 48903, Spain

Location

Related Publications (2)

• 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.

  PMID: 37875008 BACKGROUND

• 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.

  PMID: 38878265 BACKGROUND

Related Links

• Description of VOICE project in the web page of the Sponsor

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ane Fullaondo, Ph.D.

  Biosistemak (formerly Kronikgune)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 14, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: March 30, 2023
• Last Updated: March 10, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); ES (4); IT (1); BE (1); FR (1)