NCT01949974

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• Completion: 2016-06-01
• First posted: 2013-09-25
• Last updated: 2014-05-28

Locations

3 sites across 1 country: Spain