Clinical trial · Interventional
Implementation, Effectiveness and Impact of a Value Based Intervention for Patients with Breast or Lung Cancer
Value-based Healthcare for Outcomes in Breast and Lung Cancer in Europe
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VOICE intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with cancer (patients with breast cancer and patients with lung cancer)
- description
- 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.
- interventionNames
- Other: VOICE intervention
Primary outcomes (23)
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDGarcia-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
- BACKGROUNDGarcia-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