Clinical trial NCT01949974: Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients
Official title: Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cancer
Keywords: Palliative Chemotherapy
Integral Attention Program
Advanced cancer
Randomized Clinical Trial
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Survival adjusted for quality of life
timeFrame: At one year of follow-up
Secondary outcomes:
measure: 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)
timeFrame: At one year of follow-up
measure: Control of symptoms using the Edmonton Symptom Assessment System
timeFrame: At one year of follow-up
measure: Toxicity by the American National Cancer Institute toxicity
timeFrame: At one year of follow-up
measure: Patient satisfaction regarding care using a Likert scale of 5 items (very satisfied, satisfied, neither satisfied or dissatisfied, somewhat satisfied and not satisfied).
timeFrame: At one year of follow-up
measure: Costs reported by the information system of each hospital
timeFrame: At the end of follow-up
measure: Adverse effects related to study interventions
timeFrame: At one year of follow-up
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital General de l'Hospitalet de Llobregat
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Palliative Unit. Clinical Oncology Service. Hospital de la Santa Creu i Sant Pau. Barcelona. Spain.
name: Antonio Pascual, Dr., PhD
role: PRINCIPAL_INVESTIGATOR
References: