A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors
- Conditions
- Neoplasm Metastasis
- Interventions
- Other: Patient Navigation
- Registration Number
- NCT03293849
- Lead Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- Male or female patients 18 years of age and older
- Newly diagnosed stage IV solid tumor
- Recurrent stage IV solid tumor
- Homeless persons
- History of drug abuse or alcoholism
- Patients suffering from major psychotic disorders or uncontrolled psychiatric disorders
- Mentally disabled patients
- Incarcerated patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient Navigation Arm Patient Navigation After an assessment of supportive care needs, a patient navigator will present assessment results and develop and implement a personalized supportive care intervention plan based on the findings in collaboration with a multidisciplinary supportive care team, formed by oncologists and pain and palliative care specialists. The developed plan will be sent to the treating oncologist and oncology team.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Changes in self-reported pain Three months Changes in self reported pain measured using the BPI scale from baseline.
Use of chemotherapy at the end of life 18 months Interval between last administration of chemotherapy and death
Healthcare utilization 18 months Sum of hospital admissions, emergency room admissions and ICU admissions during the study period
Rate of advanced directive completion Three months Obtaining a signed advanced directive
Survival 18 months Overall survival (defined as time from study enrollment to last recorded visit or death)
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 QOL Three months Changes in QOL measured using the FACT-G from baseline.
Trial Locations
- Locations (1)
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico City, Mexico