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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01949974

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Standard Palliative Chemotherapy Other: Integral Attention Program (PAI)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

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.	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.

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.

Drug: Standard Palliative Chemotherapy

Standard Palliative Chemotherapy, depending on type cancer.

Other: Integral Attention Program (PAI)

Outcome Measures

Primary Outcome Measures

Survival adjusted for quality of life [At one year of follow-up]
Quality of life will be measured by the EuroQoL-5D questionnaire.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General de l'Hospitalet de Llobregat	Hospitalet de Llobregat	Barcelona	Spain	08906
2	Corporació Sanitària Parc Taulí	Sabadell	Barcelona	Spain
3	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025

Sponsors and Collaborators

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.