A Phase 4 interventional study of Standard Palliative Chemotherapy and Integral Attention Program (PAI) in Cancer, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Withdrawn at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-28.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 4, Interventional, and Supportive care
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.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have previously received at least one chemotherapy cycle of the following tumors:
Exclusion Criteria:
The key points of the PAI are: * To assess and manage pain and other symptoms resulting from disease progression. * To evaluate the information needs that may arise and to address them. * To encourage patient and family adaptation to the situation of advanced disease and in the terminal phase of it. * To provide guidance in decision-making while respecting patient autonomy. * To establish a plan of care and treatment, adapted to the evolution and needs of the patient. * To promote continuity of care.
Other: Integral Attention Program (PAI)
Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.
Drug: Standard Palliative Chemotherapy · Other: Integral Attention Program (PAI)
Standard Palliative Chemotherapy, depending on type cancer.
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.
Survival adjusted for quality of life
Quality of life will be measured by the EuroQoL-5D questionnaire.
Time frame: At one year of follow-up
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)
Time frame: At one year of follow-up
Control of symptoms using the Edmonton Symptom Assessment System
Time frame: At one year of follow-up
Toxicity by the American National Cancer Institute toxicity
Time frame: 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).
Time frame: At one year of follow-up
Costs reported by the information system of each hospital
Time frame: At the end of follow-up
Adverse effects related to study interventions
Time frame: At one year of follow-up
This study is withdrawn, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau