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Completed

NCT Number: NCT03216109

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Quality of Life Respiratory Tract Diseases Respiratory Tract Neoplasms Supportive Care Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weekly telephone symptom assessment

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

Primary outcomes

  1. Symptom documentation

    Time frame: 6 months after patient enrollment

    Defined as 75% documentation of symptoms for patients in the intervention arm

Secondary outcomes

  1. Emergency Department Visit (Chart Review)

    Time frame: 9 months after patient enrollment

    Emergency Department visits for each patient will be abstracted by electronic medical record for each patient at 9 months

  2. Hospitalizations (Chart Review)

    Time frame: 9 months after patient enrollment

    Hospitalizations for each patient will be abstracted by electronic medical record for each patient at 9 months

  3. Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey

    Time frame: Change in Quality of Life from baseline to month 3

    Each patient will receive a validated survey to assess quality of life at baseline and 3 months

  4. Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey

    Time frame: Change in Quality of Life from baseline to month 6

    Each patient will receive a validated survey to assess quality of life at baseline and 6 months

  5. Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey

    Time frame: Change in Quality of Life from baseline to month 9

    Each patient will receive a validated survey to assess quality of life at baseline and 9 months

  6. Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey

    Time frame: Change in patient satisfaction with decision--making from baseline to 3 months

    Each patient will receive a validated survey to assess their satisfaction with decision at baseline and 3 months

  7. Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey

    Time frame: Change in patient satisfaction with decision--making from baseline to 6 months

    Each patient will receive a validated survey to assess their satisfaction with decision at baseline and 6 months

  8. Change in patient satisfaction with decision-making using the Satisfaction with Decision Survey

    Time frame: Change in patient satisfaction with decision--making from baseline to 9 months

    Each patient will receive a validated survey to assess their satisfaction with decision at baseline and 9 months

  9. Change in Patient Activation using the validated Patient Activation Measure

    Time frame: Change in patient activation from baseline to 3 months

    Each patient will receive a validated survey to assess their activation at baseline and 3 months

  10. Change in Patient Activation using the validated Patient Activation Measure

    Time frame: Change in patient activation from baseline to 6 months

    Each patient will receive a validated survey to assess their activation at baseline and 6 months

  11. Change in Patient Activation using the validated Patient Activation Measure

    Time frame: Change in patient activation from baseline to 9 months

    Each patient will receive a validated survey to assess their activation at baseline and 9 months

  12. Change in symptoms using the validated Edmonton Symptom Assessment Scale

    Time frame: Change in symptoms from baseline to 3 months

    Each patient will receive a validated survey to assess their symptoms at baseline and 3 months

  13. Change in symptoms using the validated Edmonton Symptom Assessment Scale

    Time frame: Change in symptoms from baseline to 6 months

    Each patient will receive a validated survey to assess their symptoms at baseline and 6 months

  14. Change in symptoms using the validated Edmonton Symptom Assessment Scale

    Time frame: Change in symptoms from baseline to 9 months

    Each patient will receive a validated survey to assess their symptoms at baseline and 9 months

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • Carevive Systems, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2017
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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