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Lung CancerNCT03216109

Improving Supportive Care For Patients With Thoracic Malignancies

A study testing Weekly telephone symptom assessment in people with Lung Cancer and Quality of Life, run by Palo Alto Veterans Institute for Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Quality of Life, Supportive Care
What is being tested?
Weekly telephone symptom assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
20 Aug 2017to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients with lung cancer treated at VA Palo Alto. This includes all newly diagnosed patients and those under follow-up care.

Who cannot join

  • Patients who do not anticipate receiving oncology care at the VA Palo Alto Health Care System.
  • Patients who are unable to consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

Other trials in United States

About this study

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.

Read the 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.

Being tested
Weekly telephone symptom assessment
Keywords
Supportive Care, Quality of Life
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weekly telephone symptom assessmentBehavioural

    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

Study groups in NCT03216109
Study groupRoleWhat they receive
Weekly telephone symptom assessmentExperimentalEach 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.
Receives: Behavioral: Weekly telephone symptom assessment
Control ArmNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom documentation

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

    Measured: 6 months after patient enrollment

Secondary outcomes (14)

  1. Emergency Department Visit (Chart Review)

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

    Measured: 9 months after patient enrollment

  2. Hospitalizations (Chart Review)

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

    Measured: 9 months after patient enrollment

  3. 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

    Measured: Change in Quality of Life from baseline to month 3

  4. 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

    Measured: Change in Quality of Life from baseline to month 6

  5. 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

    Measured: Change in Quality of Life from baseline to month 9

  6. 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

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

  7. 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

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

  8. 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

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

  9. 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

    Measured: Change in patient activation from baseline to 3 months

  10. 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

    Measured: Change in patient activation from baseline to 6 months

  11. 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

    Measured: Change in patient activation from baseline to 9 months

  12. 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

    Measured: Change in symptoms from baseline to 3 months

  13. 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

    Measured: Change in symptoms from baseline to 6 months

  14. 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

    Measured: Change in symptoms from baseline to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study start20 Aug 2017
  3. Primary completion28 Jun 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216109
Sponsor's protocol ID
PAT0001ARG
Status last verified
Mar 2024
First submitted
10 Jul 2017
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38207246

  • 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.

    PubMed 35669484

Questions about this trial

What is this clinical trial studying?

A study testing Weekly telephone symptom assessment in people with Lung Cancer and Quality of Life, run by Palo Alto Veterans Institute for Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom documentation (time frame: 6 months after patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216109, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.

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Clinical Trial NCT03216109 | AzTrials