Clinical trial · Interventional
Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients
Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Dificulties in the recruitment of patients.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Integral Attention Program (PAI) | Other | — | UNRESOLVED |
| Standard Palliative Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Integral Attention Program (PAI)
- 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.
- interventionNames
- Other: Integral Attention Program (PAI)
- type
- ACTIVE_COMPARATOR
- label
- Standard Palliative Chemotherapy and PAI
- description
- Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.
- interventionNames
- Drug: Standard Palliative Chemotherapy
- Other: Integral Attention Program (PAI)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available