Clinical trial NCT03216109: Improving Supportive Care For Patients With Thoracic Malignancies
Official title: Improving Supportive Care For Patients With Thoracic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Quality of Life
Supportive Care
Keywords: Supportive Care
Quality of Life
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: Carevive Systems, Inc.
First posted: 2017-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symptom documentation
timeFrame: 6 months after patient enrollment
Secondary outcomes:
measure: Emergency Department Visit (Chart Review)
timeFrame: 9 months after patient enrollment
measure: Hospitalizations (Chart Review)
timeFrame: 9 months after patient enrollment
measure: Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey
timeFrame: Change in Quality of Life from baseline to month 3
measure: Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey
timeFrame: Change in Quality of Life from baseline to month 6
measure: Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey
timeFrame: Change in Quality of Life from baseline to month 9
measure: Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey
timeFrame: Change in patient satisfaction with decision--making from baseline to 3 months
measure: Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey
timeFrame: Change in patient satisfaction with decision--making from baseline to 6 months
measure: Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey
timeFrame: Change in patient satisfaction with decision--making from baseline to 9 months
measure: Change in Patient Activation using the validated Patient Activation Measure
timeFrame: Change in patient activation from baseline to 3 months
measure: Change in Patient Activation using the validated Patient Activation Measure
timeFrame: Change in patient activation from baseline to 6 months
measure: Change in Patient Activation using the validated Patient Activation Measure
timeFrame: Change in patient activation from baseline to 9 months
measure: Change in symptoms using the validated Edmonton Symptom Assessment Scale
timeFrame: Change in symptoms from baseline to 3 months
measure: Change in symptoms using the validated Edmonton Symptom Assessment Scale
timeFrame: Change in symptoms from baseline to 6 months
measure: Change in symptoms using the validated Edmonton Symptom Assessment Scale
timeFrame: Change in symptoms from baseline to 9 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: Faculty
name: Manali I Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.