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Clinical Trials/NCT03216109
NCT03216109CompletedNot Applicable

Improving Supportive Care For Patients With Thoracic Malignancies

Palo Alto Veterans Institute for Research2 sites in 1 country60 target enrollmentStarted: August 20, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Symptom documentation

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Symptom documentation

Time Frame: 6 months after patient enrollment

Defined as 75% documentation of symptoms for patients in the intervention arm

Secondary Outcomes

  • Emergency Department Visit (Chart Review)(9 months after patient enrollment)
  • Hospitalizations (Chart Review)(9 months after patient enrollment)
  • Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey(Change in Quality of Life from baseline to month 9)
  • Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey(Change in patient satisfaction with decision--making from baseline to 9 months)
  • Change in Patient Activation using the validated Patient Activation Measure(Change in patient activation from baseline to 9 months)
  • Change in symptoms using the validated Edmonton Symptom Assessment Scale(Change in symptoms from baseline to 9 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Manali Patel

Principal Investigator Staff Oncologist VAPAHCS

Palo Alto Veterans Institute for Research

Study Sites (2)

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