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

Phase 4

Withdrawn

• Conditions: Cancer
• Interventions: Other: Integral Attention Program (PAI); Drug: Standard Palliative Chemotherapy

• Registration Number: NCT01949974
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-08
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-25
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-28
• Primary Completion: 2014-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integral Attention Program (PAI)	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.
Standard Palliative Chemotherapy and PAI	Standard Palliative Chemotherapy	Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.
Standard Palliative Chemotherapy and PAI	Integral Attention Program (PAI)	Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
Toxicity by the American National Cancer Institute toxicity	At one year of follow-up

Trial Locations

Locations (3)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital General de l'Hospitalet de Llobregat; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain