Improving Supportive Care For Patients With Thoracic Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Lung Cancer; Supportive Care
• Intervention / Treatment: Behavioral: Weekly telephone symptom assessment

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekly telephone symptom assessment; 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; 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
No Intervention: Control Arm; 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?

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

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: Carevive Systems, Inc.
• Investigators: Principal Investigator: Manali I Patel, MD, Faculty

Publications and helpful links

General Publications

• Patel MI, Banks L, Das M. Improving supportive care for patients with Thoracic Malignancies - A randomized controlled trial. Contemp Clin Trials Commun. 2022 May 27;28:100929. doi: 10.1016/j.conctc.2022.100929. eCollection 2022 Aug.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Supportive Care
• Other Study ID Numbers: PAT0001ARG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No