A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03293849|
Recruitment Status : Active, not recruiting
First Posted : September 26, 2017
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Metastasis||Other: Patient Navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|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|
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.
- 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.
- Rate of advanced directive completion [ Time Frame: Three months ]Obtaining a signed advanced directive
- 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
- Changes in QOL [ Time Frame: Three months ]Changes in QOL measured using the FACT-G from baseline.
- Changes in self-reported pain [ Time Frame: Three months ]Changes in self reported pain measured using the BPI scale from baseline.
- Use of chemotherapy at the end of life [ Time Frame: 18 months ]Interval between last administration of chemotherapy and death
- Healthcare utilization [ Time Frame: 18 months ]Sum of hospital admissions, emergency room admissions and ICU admissions during the study period
- Survival [ Time Frame: 18 months ]Overall survival (defined as time from study enrollment to last recorded visit or death)
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 ClinicalTrials.gov identifier (NCT number): NCT03293849
|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|
|Mexico City, Mexico, 14080|
|Principal Investigator:||Enrique Soto Perez de Celis, MD, MSc||Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|