Neoplasm Metastasis
Conditions
Brief summary
In this randomized clinical trial, patients with Stage IV solid tumors will be enrolled in a patient navigator-led generalist palliative and supportive care intervention or in usual care led by their treating physician. The patient navigator will assess the patient's palliative and supportive care needs using standardized quality of life and symptoms questionnaires and present this assessment to a multidisciplinary team composed of oncologists and palliative care specialist. The multidisciplinary team will develop a personalized supportive care plan for the patient which will then be presented and discussed by the patient navigator. Those interventions which are accepted by the patient will be implemented by the patient navigator, who will also provide education and teaching. The patient navigator will also help eligible patients complete advanced directives according to local rules and regulations. The patient navigator will follow the patients both in person and by telephone to ensure that the recommended interventions have been implemented. Three months after enrollment the patients will undergo quality of life and symptom assessment once again, and the implementation of interventions will be recorded.
Interventions
OTHERPatient Navigation
The patient navigator will discuss the results and supportive care recommended interventions of the multidisciplinary team with the patient. Those interventions which are accepted by patient are initiated when possible, and referrals are made as planned. The study patient navigator will review advance directive planning with those patients who are candidates to complete an advanced directive under Mexican law, and will facilitate the resources to complete the advance directive.
Sponsors
Global Cancer Institute
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients 18 years of age and older 2. Newly diagnosed stage IV solid tumor 3. Recurrent stage IV solid tumor
Exclusion criteria
1. Homeless persons 2. History of drug abuse or alcoholism 3. Patients suffering from major psychotic disorders or uncontrolled psychiatric disorders 4. Mentally disabled patients 5. Incarcerated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Referrals to Supportive Care Services | Three months | Proportion of patients who agree to participate in the patient navigation program, complete the initial assessment, meet with the patient navigator to discuss advanced care planning and supportive care interventions and obtain the appropriate referrals and consultations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of advanced directive completion | Three months | Obtaining a signed advanced directive |
| Implementation of planned supportive care interventions | Three months | Documentation of the planned interventions on the patient's medical record at end-of-study |
| Changes in self-reported pain | Three months | Changes in self reported pain measured using the BPI scale from baseline. |
| Changes in QOL | Three months | Changes in QOL measured using the FACT-G from baseline. |
| Healthcare utilization | 18 months | Sum of hospital admissions, emergency room admissions and ICU admissions during the study period |
| Survival | 18 months | Overall survival (defined as time from study enrollment to last recorded visit or death) |
| Use of chemotherapy at the end of life | 18 months | Interval between last administration of chemotherapy and death |
Countries
Mexico
Outcome results
None listed