- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01949974
Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients (PAI)
Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain, 08025
- Hospital de La Santa Creu I Sant Pau
-
-
Barcelona
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Hospitalet de Llobregat, Barcelona, Spain, 08906
- Hospital General de l'Hospitalet de Llobregat
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Sabadell, Barcelona, Spain
- Corporacio Sanitaria Parc Tauli
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Cancer of the digestive and gastrointestinal tract
- Head and Neck Cancer
- Lung cancer
- Urologic cancers
- Gynecologic cancers
- Central nervous system cancer
- Melanoma
- 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:
- Patients who are currently receiving chemotherapy, although patient pursuing any other concomitant treatment are eligible (eg, hormone therapy or radiation therapy).
- Patients who have contraindications to chemotherapy.
- Patients who did not agree to participate in the clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Integral Attention Program (PAI)
The key points of the PAI are:
|
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.
|
Active Comparator: Standard Palliative Chemotherapy and PAI
Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.
|
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.
Standard Palliative Chemotherapy, depending on type cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival adjusted for quality of life
Time Frame: At one year of follow-up
|
Quality of life will be measured by the EuroQoL-5D questionnaire.
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At one year of follow-up
|
Secondary Outcome Measures
Outcome Measure |
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)
Time Frame: At one year of follow-up
|
At one year of follow-up
|
Control of symptoms using the Edmonton Symptom Assessment System
Time Frame: At one year of follow-up
|
At one year of follow-up
|
Toxicity by the American National Cancer Institute toxicity
Time Frame: At one year of follow-up
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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
|
At one year of follow-up
|
Costs reported by the information system of each hospital
Time Frame: At the end of follow-up
|
At the end of follow-up
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Adverse effects related to study interventions
Time Frame: At one year of follow-up
|
At one year of follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Antonio Pascual, Dr., PhD, Palliative Unit. Clinical Oncology Service. Hospital de la Santa Creu i Sant Pau. Barcelona. Spain.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IIBSP-PAI-2011-36
- 2012-001128-36 (EudraCT Number)
- PI11/01366 (Other Grant/Funding Number: Institute of Health Carlos III)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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