Improving Supportive Care For Patients With Thoracic Malignancies

Study Overview
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Brief Summary
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The purpose of this study is to use a proactive approach to improve symptom management of patients with thoracic malignancies and ensure receipt of evidence-based cancer care delivery. In this pilot study, the investigators propose to evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies and ensuring evidence-based care receipt and measure the efficacy of this approach on patient satisfaction with their care, patient activation, quality of life and use of healthcare resources.

Detailed Description
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The investigators have previously shown in previous work that patients and caregivers who experience thoracic malignancies express poor symptom management that result in utilization of healthcare resources after-hours for symptoms that could have been prevented if assessed more proactively and prospectively. Currently, there are limited proactive approaches to prospectively identify and intervene on patient-reported symptoms. The purpose of this study is to enhance symptom assessment strategies by using a proactive assessment approach to improve symptom relief for patients with thoracic malignancies. The investigators will test whether a proactive telephone symptom assessment and management strategy is feasible and can facilitate early patient report of their symptoms and intervention. The knowledge gained from this approach will be used to identify solutions that can be scaled nationally to improve patient-reported symptom management and patient satisfaction with their clinical care.

Official Title
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Improving Supportive Care For Patients With Thoracic Malignancies

Conditions
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Lung Cancer, Quality of Life, Supportive Care

Intervention / Treatment
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* Behavioral: Weekly telephone symptom assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with lung cancer treated at VA Palo Alto. This includes all newly diagnosed patients and those under follow-up care. Exclusion Criteria: Patients who do not anticipate receiving oncology care at the VA Palo Alto Health Care System. Patients who are unable to consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly telephone symptom assessment<br>Each patient who is enrolled in the intervention will receive a weekly phone call from the Research Assistant for a total of 9 months to assess symptoms using the Edmonton Symptom Assessment Scale. Results of the symptom assessments will be provided to the clinic staff (RN and MD) for review each week. Symptom assessments will be documented into an encrypted, HIPAA compliant digital platform which provides longitudinal symptom data management and also provides symptom assessment tools for the clinical team in their intervention strategies. In addition, patients will complete symptom and quality of life surveys at 0, 3, 6 and 9 months. | Behavioral: Weekly telephone symptom assessment<br>* Each patient who is enrolled in the intervention will receive a weekly phone call from the Research Assistant for a total of 9 months to assess symptoms using the Edmonton Symptom Assessment Scale. Results of the symptom assessments will be provided to the clinic staff (RN and MD) for review each week. Care plans will be generated using an electronic management platform<br>|
| No Intervention: Control Arm<br>Patients randomized to usual clinical care will receive standard of care for thoracic malignancies as provided by the VA Palo Alto Health Care System. Patients will complete outcome surveys at 0, 3, 6, and 9 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom documentation | Defined as 75% documentation of symptoms for patients in the intervention arm | 6 months after patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Department Visit (Chart Review) | Emergency Department visits for each patient will be abstracted by electronic medical record for each patient at 9 months | 9 months after patient enrollment | 
| Hospitalizations (Chart Review) | Hospitalizations for each patient will be abstracted by electronic medical record for each patient at 9 months | 9 months after patient enrollment | 
| Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey | Each patient will receive a validated survey to assess quality of life at baseline and 3 months | Change in Quality of Life from baseline to month 3 | 
| Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey | Each patient will receive a validated survey to assess quality of life at baseline and 6 months | Change in Quality of Life from baseline to month 6 | 
| Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey | Each patient will receive a validated survey to assess quality of life at baseline and 9 months | Change in Quality of Life from baseline to month 9 | 
| Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey | Each patient will receive a validated survey to assess their satisfaction with decision at baseline and 3 months | Change in patient satisfaction with decision--making from baseline to 3 months | 
| Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey | Each patient will receive a validated survey to assess their satisfaction with decision at baseline and 6 months | Change in patient satisfaction with decision--making from baseline to 6 months | 
| Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey | Each patient will receive a validated survey to assess their satisfaction with decision at baseline and 9 months | Change in patient satisfaction with decision--making from baseline to 9 months | 
| Change in Patient Activation using the validated Patient Activation Measure | Each patient will receive a validated survey to assess their activation at baseline and 3 months | Change in patient activation from baseline to 3 months | 
| Change in Patient Activation using the validated Patient Activation Measure | Each patient will receive a validated survey to assess their activation at baseline and 6 months | Change in patient activation from baseline to 6 months | 
| Change in Patient Activation using the validated Patient Activation Measure | Each patient will receive a validated survey to assess their activation at baseline and 9 months | Change in patient activation from baseline to 9 months | 
| Change in symptoms using the validated Edmonton Symptom Assessment Scale | Each patient will receive a validated survey to assess their symptoms at baseline and 3 months | Change in symptoms from baseline to 3 months | 
| Change in symptoms using the validated Edmonton Symptom Assessment Scale | Each patient will receive a validated survey to assess their symptoms at baseline and 6 months | Change in symptoms from baseline to 6 months | 
| Change in symptoms using the validated Edmonton Symptom Assessment Scale | Each patient will receive a validated survey to assess their symptoms at baseline and 9 months | Change in symptoms from baseline to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supportive Care, Quality of Life