Value-based Healthcare for Outcomes in Breast and Lung Cancer in Europe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,007
- Locations
- 16
- Primary Endpoint
- Change from baseline overall well-being for patients with breast cancer at 6 months
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from baseline overall well-being for patients with breast cancer at 6 months
Time Frame: 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.
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.
Change from baseline Asthenia and fatigue (including physical functioning) at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Arm and breast symptoms for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---BR23 (BR23: Breast Cancer Module).
Change from baseline Adverse effects: peripheral neuropathy for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Vaginal symptoms for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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).
Change from baseline Sexual functioning for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---BR23 (BR23: Breast Cancer Module).
Change from baseline Satisfaction with breasts for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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).
Change from baseline Adverse effects: Arthralgia for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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).
Change from baseline Fatigue for patients with lung cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Cognitive function for patients with Lung Cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Emotional functioning (also including anxiety and depression) for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Cognitive functioning for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Emotional functioning for patients with lung cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Shortness of breath for patients with Lung Cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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).
Change from baseline Social and working functioning (also including financial impact) for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Body image for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---BR23 (BR23: Breast Cancer Module).
Change from baseline Adverse effects: vasomotor symptoms for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six months.
Outcome measure reported by patients with breast cancer by means of completion of the questionnaire EORTC QLQ---BR23 (BR23: Breast Cancer Module).
Change from baseline Global health status / Quality of life for patients with Lung Cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Cough for patients with lung cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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).
Change from baseline Quality of life for patients with breast cancer at 6 months
Time Frame: Breast Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Social function for patients with lung cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Physical functioning for patients with Lung Cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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.
Change from baseline Pain for patients with lung cancer at 6 months
Time Frame: Lung Cancer patients completed the PROMs questionnaires at baseline and after six 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).
Secondary Outcomes
- 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)
- Average total cost per patient with lung cancer(For Lung cancer patients, during the intervention at 12 months period since the diagnostic)