Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients

Cancer Clinical Trial

— PAI  

Official title:

Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01949974
• Other study ID #: IIBSP-PAI-2011-36
• Secondary ID: 2012-001128-36PI
• Status: Withdrawn
• Phase: Phase 4
• First received: September 17, 2013
• Last updated: May 27, 2014
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2013
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Standard Palliative Chemotherapy
Standard Palliative Chemotherapy, depending on type cancer.

Other:
• Integral Attention Program (PAI)
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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital General de l'Hospitalet de Llobregat	Hospitalet de Llobregat	Barcelona
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival adjusted for quality of life	Quality of life will be measured by the EuroQoL-5D questionnaire.	At one year of follow-up	No
Secondary	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	No
Secondary	Control of symptoms using the Edmonton Symptom Assessment System		At one year of follow-up	No
Secondary	Toxicity by the American National Cancer Institute toxicity		At one year of follow-up	Yes
Secondary	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	No
Secondary	Costs reported by the information system of each hospital		At the end of follow-up	No
Secondary	Adverse effects related to study interventions		At one year of follow-up	Yes