Clinical trial NCT03293849: A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors
Official title: A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm Metastasis
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Global Cancer Institute
First posted: 2017-09-26
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Referrals to Supportive Care Services
timeFrame: Three months
Secondary outcomes:
measure: Rate of advanced directive completion
timeFrame: Three months
measure: Implementation of planned supportive care interventions
timeFrame: Three months
measure: Changes in QOL
timeFrame: Three months
measure: Changes in self-reported pain
timeFrame: Three months
measure: Use of chemotherapy at the end of life
timeFrame: 18 months
measure: Healthcare utilization
timeFrame: 18 months
measure: Survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Enrique Soto Perez de Celis, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: