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

NCT03293849 | Completed DMC

• 1 other identifier: REF. 2191
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of advanced directive completion

  Three months

• Implementation of planned supportive care interventions

  Three months

• Changes in QOL

  Three months

• Changes in self-reported pain

  Three months

• Use of chemotherapy at the end of life

  18 months

Study Arms (2)

Patient Navigation Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

Patient Navigation OTHER

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.

Patient Navigation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 years of age and older
• Newly diagnosed stage IV solid tumor
• Recurrent stage IV solid tumor

You may not qualify if:

• Homeless persons
• History of drug abuse or alcoholism
• Patients suffering from major psychotic disorders or uncontrolled psychiatric disorders
• Mentally disabled patients
• Incarcerated patients

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Global Cancer Institute: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Enrique Soto Perez de Celis, MD, MSc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 26, 2017
• Study Start: August 1, 2017
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: February 12, 2020

Record last verified: 2019-07

Locations

ME (1)