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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001128-36 | EudraCT Number | ||
| PI11/01366 | Other Grant/Funding Number | Institute of Health Carlos III |
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Dificulties in the recruitment of patients.
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The purpose of this clinical trial is to compare a non-pharmaceutical intervention (Integral Attention Program or PAI) versus standard palliative chemotherapy treatment plus PAI in patients with advanced cancer who have already received at least a first course of chemotherapy but had proven therapeutic failure.
The study hypothesis is that palliative chemotherapy offers no clear benefits in relation to quality-of-life-adjusted survival compared to a comprehensive care program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integral Attention Program (PAI) | Experimental | The key points of the PAI are:
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| Standard Palliative Chemotherapy and PAI | Active Comparator | Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Palliative Chemotherapy | Drug | Standard Palliative Chemotherapy, depending on type cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival adjusted for quality of life | Quality of life will be measured by the EuroQoL-5D questionnaire. | At one year of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Specific Quality of life: measured through the quality of life questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ C-30) and Palliative Care Scale (POS) | At one year of follow-up | |
| Control of symptoms using the Edmonton Symptom Assessment System |
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Inclusion Criteria:
Men and women ≥18 years of age.
Patients potentially eligible to receive a new chemotherapy cycle and whose clinical condition, according to the oncologist, does not identify any therapeutic strategy clearly superior to another, in the light of scientific evidence.
Patients with advanced cancers that have been treated with chemotherapy but who have not displayed complete response to treatment or who, after treatment response, are now in a situation of recurrence or disease progression
Patients who have previously received at least one chemotherapy cycle of the following tumors:
Patients who can potentially comply with study and/or monitoring procedures and to accept and sign the informed consent form.
Patients whose home is located less than 10 km, approximately, of the hospitals participating in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Pascual, Dr., PhD | Palliative Unit. Clinical Oncology Service. Hospital de la Santa Creu i Sant Pau. Barcelona. Spain. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de l'Hospitalet de Llobregat | L'Hospitalet de Llobregat | Barcelona | 08906 | Spain | ||
| Corporació Sanitària Parc Taulí |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Integral Attention Program (PAI) | Other | The PAI is a plan of care and treatment adapted in accordance with the evolution and needs of patients. This plan includes an initial comprehensive assessment of patients and their families during the first visit, including specialized psychological and social support when needed, voluntary art therapy and/or mindfulness. There will be outpatient monitoring, 24h phone assistance, home visits, support should hospitalization be required, and unscheduled visits by a palliative care team. |
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| At one year of follow-up |
| Toxicity by the American National Cancer Institute toxicity | At one year of follow-up |
| Patient satisfaction regarding care using a Likert scale of 5 items (very satisfied, satisfied, neither satisfied or dissatisfied, somewhat satisfied and not satisfied). | At one year of follow-up |
| Costs reported by the information system of each hospital | At the end of follow-up |
| Adverse effects related to study interventions | At one year of follow-up |
| Sabadell |
| Barcelona |
| Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |