A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors

Neoplasm Metastasis Clinical Trial

Official title:

A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293849
• Other study ID #: REF. 2191
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2019
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

Other:
• Patient 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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Global Cancer Institute

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Referrals to Supportive Care Services	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.	Three months
Secondary	Rate of advanced directive completion	Obtaining a signed advanced directive	Three months
Secondary	Implementation of planned supportive care interventions	Documentation of the planned interventions on the patient's medical record at end-of-study	Three months
Secondary	Changes in QOL	Changes in QOL measured using the FACT-G from baseline.	Three months
Secondary	Changes in self-reported pain	Changes in self reported pain measured using the BPI scale from baseline.	Three months
Secondary	Use of chemotherapy at the end of life	Interval between last administration of chemotherapy and death	18 months
Secondary	Healthcare utilization	Sum of hospital admissions, emergency room admissions and ICU admissions during the study period	18 months
Secondary	Survival	Overall survival (defined as time from study enrollment to last recorded visit or death)	18 months