Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
NCT Number: NCT03293849
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Mexico City, 14080, Mexico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Three months
Obtaining a signed advanced directive
Time frame: Three months
Documentation of the planned interventions on the patient's medical record at end-of-study
Time frame: Three months
Changes in QOL measured using the FACT-G from baseline.
Time frame: Three months
Changes in self reported pain measured using the BPI scale from baseline.
Time frame: 18 months
Interval between last administration of chemotherapy and death
Time frame: 18 months
Sum of hospital admissions, emergency room admissions and ICU admissions during the study period
Time frame: 18 months
Overall survival (defined as time from study enrollment to last recorded visit or death)
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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