Improving Supportive Care For Patients With Thoracic Malignancies

Lung Cancer Clinical Trial

Official title:

Improving Supportive Care For Patients With Thoracic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216109
• Other study ID #: PAT0001ARG
• Status: Completed
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Quality of Life
• Supportive Care

Intervention

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

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Carevive Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom documentation	Defined as 75% documentation of symptoms for patients in the intervention arm	6 months after patient enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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