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• Status: Withdrawn
• Conditions: Cancer
• Intervention / Treatment: Other: Integral Attention Program (PAI); Drug: Standard Palliative Chemotherapy

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08906
      • Hospital General de l'Hospitalet de Llobregat
    • Sabadell, Barcelona, Spain
      • Corporacio Sanitaria Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integral Attention Program (PAI); 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); 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.	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.; Drug: Standard Palliative Chemotherapy; 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	Quality of life will be measured by the EuroQoL-5D questionnaire.	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)	At one year of follow-up
Control of symptoms using the Edmonton Symptom Assessment System	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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• 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: June 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 20, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 28, 2014
• Last Update Submitted That Met QC Criteria: May 27, 2014
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Advanced cancer; Randomized Clinical Trial; Palliative Chemotherapy; Integral Attention Program
• Other Study ID Numbers: IIBSP-PAI-2011-36; 2012-001128-36 (EudraCT Number); PI11/01366 (Other Grant/Funding Number: Institute of Health Carlos III)