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

Primary Purpose

Neoplasm Metastasis

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasm Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Navigation Arm

Control Arm

Arm Description

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.

Assessment results will be provided in printed and electronic form to the treating oncologist for their review. Referrals or interventions for patients allocated to the control arm will be coordinated by the treating oncologist without involvement from the patient navigator or the study team.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2017
Last Updated
February 11, 2020
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Global Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03293849
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 20, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Global Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Navigation Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Assessment results will be provided in printed and electronic form to the treating oncologist for their review. Referrals or interventions for patients allocated to the control arm will be coordinated by the treating oncologist without involvement from the patient navigator or the study team.
Intervention Type
Other
Intervention Name(s)
Patient Navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Referrals to Supportive Care Services
Description
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
Secondary Outcome Measure Information:
Title
Rate of advanced directive completion
Description
Obtaining a signed advanced directive
Time Frame
Three months
Title
Implementation of planned supportive care interventions
Description
Documentation of the planned interventions on the patient's medical record at end-of-study
Time Frame
Three months
Title
Changes in QOL
Description
Changes in QOL measured using the FACT-G from baseline.
Time Frame
Three months
Title
Changes in self-reported pain
Description
Changes in self reported pain measured using the BPI scale from baseline.
Time Frame
Three months
Title
Use of chemotherapy at the end of life
Description
Interval between last administration of chemotherapy and death
Time Frame
18 months
Title
Healthcare utilization
Description
Sum of hospital admissions, emergency room admissions and ICU admissions during the study period
Time Frame
18 months
Title
Survival
Description
Overall survival (defined as time from study enrollment to last recorded visit or death)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Soto Perez de Celis, MD, MSc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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