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Improving Supportive Care For Patients With Thoracic Malignancies

Improving Supportive Care For Patients With Thoracic Malignancies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03216109
Enrollment
60
Registered
2017-07-13
Start date
2017-08-20
Completion date
2023-12-31
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Quality of Life, Supportive Care

Keywords

Supportive Care, Quality of Life

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.

Interventions

BEHAVIORALWeekly 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

Sponsors

Carevive Systems, Inc.
CollaboratorINDUSTRY
Palo Alto Veterans Institute for Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Symptom documentation6 months after patient enrollmentDefined as 75% documentation of symptoms for patients in the intervention arm

Secondary

MeasureTime frameDescription
Hospitalizations (Chart Review)9 months after patient enrollmentHospitalizations for each patient will be abstracted by electronic medical record for each patient at 9 months
Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung surveyChange in Quality of Life from baseline to month 3Each patient will receive a validated survey to assess quality of life at baseline and 3 months
Emergency Department Visit (Chart Review)9 months after patient enrollmentEmergency Department visits for each patient will be abstracted by electronic medical record for each patient at 9 months
Change in Patient Activation using the validated Patient Activation MeasureChange in patient activation from baseline to 3 monthsEach patient will receive a validated survey to assess their activation at baseline and 3 months
Change in symptoms using the validated Edmonton Symptom Assessment ScaleChange in symptoms from baseline to 3 monthsEach patient will receive a validated survey to assess their symptoms at baseline and 3 months
Change in patient satisfaction with decision-making using the Satisfaction with Decision SurveyChange in patient satisfaction with decision--making from baseline to 3 monthsEach patient will receive a validated survey to assess their satisfaction with decision at baseline and 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026