Elsevier

Contemporary Clinical Trials

Volume 72, September 2018, Pages 26-34
Contemporary Clinical Trials

Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned

https://doi.org/10.1016/j.cct.2018.07.007Get rights and content

Abstract

Purpose

We describe the methods, stakeholder engagement, and lessons learned from a study comparing a video decision aid to standard educational materials on lung cancer screening decisions.

Methods

The study followed rigorous methodology standards from the Patient-Centered Outcomes Research Institute. The importance of patient-centeredness and patient/stakeholder engagement are reflected across the study's conceptualization, execution, interpretation, and dissemination efforts. Advisory groups of current and former smokers, quitline service providers, clinicians, and patient advocates were formed for the project. The study used both retrospective and prospective recruitment strategies. Randomization of patients occurred within state-based quitlines, with aggressive tracking of participants. We collected data at baseline and 1-week, 3-month and 6-months after receiving the intervention. The patient-centered outcomes included whether patients' receiving the decision aid a) felt better prepared to make a decision, b) felt more informed about the screening decision, c) had more clarity on their values regarding the benefits and harms of lung cancer screening, and d) were more knowledgeable about lung cancer screening than patients receiving the standard education materials. Exploratory outcomes included making an appointment with a health care provider to discuss screening, scheduling and completing lung cancer screening.

Results

We have enrolled and randomized 516 quitline patients and learned many lessons about executing the trial based on significant patient and stakeholder engagement.

Conclusions

Conducting patient-centered outcomes research requires new ways of thinking and continuously checking-in with patients/stakeholders. The engagement of quitline service providers and patient advisors has been key to successful recruitment and dissemination planning.

PCORI- CER-1306-03385

ClinicalTrials.gov NCT ID: NCT02286713

Section snippets

Introduction and background

Lung cancer is the second most common cancer and the leading cause of cancer deaths in the U.S. [1]. Five-year survival rates are only about 16.6%, in part because many patients have advanced disease at the time of diagnosis [2]. Smoking is the most important risk factor for developing and dying from lung cancer and is thought to cause about 90% of all lung cancers in the U.S [1, 3].

In June 2011, the National Lung Screening Trial (NLST) published its primary finding where 20% fewer lung cancer

Study aim and hypotheses

The aim of this study is to compare a video-based decision aid to standard educational materials on quitline patients' preparation to make a decision about lung cancer screening. The goal of the video-based decision aid is to prepare patients to have a conversation with their primary care provider and not to sway patients to be for or against lung cancer screening. We hypothesized that high-risk smokers eligible for lung cancer screening who receive the decision aid would: a) be more prepared

State quitlines

Four quitline service providers covering 13 states participated in the study. Our initial quitline partnerships were with the Alabama Tobacco Quitline and Tennessee Tobacco Quitline operated by Information & Quality Healthcare, which prospectively and retrospectively recruited participants. Then we expanded to the New York State Smokers' Quitline run by Roswell Park Cancer Institute. They had additional resources, which enabled us to send the recruitment materials directly to the state tobacco

Lessons learned

There were many lessons learned regarding working with state tobacco quitlines and high-risk smokers (Table 1). By working closely with our states and quitline service providers to get their input on realistic roles and expectations for the project, we were able to meet the needs of states and quitline service providers. As a result, we tailored study procedures for each state or quitline service provider. It also made it easier for us to expand our efforts to multiple states when the quitline

Acknowledgements

The authors would like to thank Vincent Richards, Andrea Palmieri Hempstead, and Rhodrick Harralson for data collection.

Ethics, consent, and permissions

This study was approved by the University of Texas MD Anderson Cancer Center Institutional Review Board [IRB APPROVAL 2014-0628].

Funding

This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1306-03385), the NIH/NCI under award number P30CA016672 and used the Biostatistics Resource Group and Clinical Protocal and Data Management, and The University of Texas MD Anderson Cancer CenterDuncan Family Institute for Cancer Prevention and Risk Assessment. All statements in this article, including its findings and conclusions, are solely those of the authors and do not necessarily represent the

References (26)

  • R. Wender et al.

    American Cancer Society lung cancer screening guidelines

    CA Cancer J. Clin.

    (2013)
  • V.A. Moyer

    U. S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement

    Ann. Intern. Med.

    (2014)
  • R.J. Volk et al.

    Trials of decision aids for prostate cancer screening: a systematic review

    Am. J. Prev. Med.

    (2007)
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