Improving Supportive Care For Patients With Thoracic Malignancies

NCT ID: NCT03216109

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-20
• Study Completion Date: 2023-12-31

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.

Conditions

Lung Cancer; Quality of Life; Supportive Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Weekly telephone symptom assessment

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carevive Systems, Inc.

INDUSTRY

Sponsor Role: collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

Manali Patel

Principal Investigator Staff Oncologist VAPAHCS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manali I Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Countries

United States

References

Banks LC, Kapphahn K, Das M, Patel MI. Randomized Trial of a Volunteer-Led Symptom Assessment Intervention on Documentation, Patient-Reported Outcomes, and Health Care Use Among Veterans With Lung Cancer. JCO Oncol Pract. 2024 Mar;20(3):419-428. doi: 10.1200/OP.23.00557. Epub 2024 Jan 11.

Reference Type: DERIVED

PMID: 38207246 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35669484 (View on PubMed)

Other Identifiers

PAT0001ARG

Identifier Type: -

Identifier Source: org_study_id