A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neoplasm Metastasis
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Referrals to Supportive Care Services
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients 18 years of age and older
- •Newly diagnosed stage IV solid tumor
- •Recurrent stage IV solid tumor
Exclusion Criteria
- •Homeless persons
- •History of drug abuse or alcoholism
- •Patients suffering from major psychotic disorders or uncontrolled psychiatric disorders
- •Mentally disabled patients
- •Incarcerated patients
Outcomes
Primary Outcomes
Referrals to Supportive Care Services
Time Frame: 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 Outcomes
- Use of chemotherapy at the end of life(18 months)
- Changes in self-reported pain(Three months)
- Healthcare utilization(18 months)
- Rate of advanced directive completion(Three months)
- Survival(18 months)
- Implementation of planned supportive care interventions(Three months)
- Changes in QOL(Three months)