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

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

Status and phase: Withdrawn; Phase 4

Conditions: Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01949974

PI11/01366 (Other Grant/Funding Number)

IIBSP-PAI-2011-36

2012-001128-36 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Integral Attention Program (PAI)

Experimental group

Description:

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.

Treatment:

Other: Integral Attention Program (PAI)

Standard Palliative Chemotherapy and PAI

Active Comparator group

Description:

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

Treatment:

Other: Integral Attention Program (PAI)

Drug: Standard Palliative Chemotherapy