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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03293849
Recruitment Status : Active, not recruiting
First Posted : September 26, 2017
Last Update Posted : May 7, 2018
Global Cancer Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Other: Patient Navigation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 20, 2018
Estimated Study Completion Date : July 20, 2019

Arm Intervention/treatment
Experimental: Patient Navigation Arm
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.
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.

No Intervention: Control Arm
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.

Primary Outcome Measures :
  1. Referrals to Supportive Care Services [ 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.

Secondary Outcome Measures :
  1. Rate of advanced directive completion [ Time Frame: Three months ]
    Obtaining a signed advanced directive

  2. Implementation of planned supportive care interventions [ Time Frame: Three months ]
    Documentation of the planned interventions on the patient's medical record at end-of-study

  3. Changes in QOL [ Time Frame: Three months ]
    Changes in QOL measured using the FACT-G from baseline.

  4. Changes in self-reported pain [ Time Frame: Three months ]
    Changes in self reported pain measured using the BPI scale from baseline.

  5. Use of chemotherapy at the end of life [ Time Frame: 18 months ]
    Interval between last administration of chemotherapy and death

  6. Healthcare utilization [ Time Frame: 18 months ]
    Sum of hospital admissions, emergency room admissions and ICU admissions during the study period

  7. Survival [ Time Frame: 18 months ]
    Overall survival (defined as time from study enrollment to last recorded visit or death)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03293849

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Global Cancer Institute
Principal Investigator: Enrique Soto Perez de Celis, MD, MSc Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Identifier: NCT03293849     History of Changes
Other Study ID Numbers: REF. 2191
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes