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

NCT ID: NCT01949974

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Integral Attention Program (PAI)

Intervention Type: OTHER

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 and PAI

Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.

Group Type: ACTIVE_COMPARATOR

Standard Palliative Chemotherapy

Intervention Type: DRUG

Standard Palliative Chemotherapy, depending on type cancer.

Integral Attention Program (PAI)

Intervention Type: OTHER

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.

Interventions

Standard Palliative Chemotherapy

Standard Palliative Chemotherapy, depending on type cancer.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Pascual, Dr., PhD

Role: PRINCIPAL_INVESTIGATOR

Palliative Unit. Clinical Oncology Service. Hospital de la Santa Creu i Sant Pau. Barcelona. Spain.

Locations

Hospital General de l'Hospitalet de Llobregat

L'Hospitalet de Llobregat, Barcelona, Spain

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

Other Identifiers

2012-001128-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PI11/01366

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIBSP-PAI-2011-36

Identifier Type: -

Identifier Source: org_study_id