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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

Conditions: Neoplasm Metastasis

Treatments: Other: Patient Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03293849

REF. 2191

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Patient Navigation Arm

Experimental group

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.

Treatment:

Other: Patient Navigation

Control Arm

No Intervention group

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.