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

NCT01949974 | Withdrawn Phase 4

• 3 other identifiers: IIBSP-PAI-2011-362012-001128-36PI11/01366
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Keywords

Palliative Chemotherapy; Integral Attention Program; Advanced cancer; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Survival adjusted for quality of life

  Quality of life will be measured by the EuroQoL-5D questionnaire.

  At one year of follow-up

Secondary Outcomes (6)

• 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

Study Arms (2)

Integral Attention Program (PAI)

EXPERIMENTAL

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)

Standard Palliative Chemotherapy and PAI

ACTIVE COMPARATOR

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

Drug: Standard Palliative Chemotherapy; Other: Integral Attention Program (PAI)

Interventions

Standard Palliative Chemotherapy DRUG

Standard Palliative Chemotherapy, depending on type cancer.

Standard Palliative Chemotherapy and PAI

Integral Attention Program (PAI) 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.

Integral Attention Program (PAI); Standard Palliative Chemotherapy and PAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Hospital General de l'Hospitalet de Llobregat

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

Location

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Antonio Pascual, Dr., PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 25, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2016
• Last Updated: May 28, 2014

Record last verified: 2013-08

Locations

ES (3)