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Completed

NCT Number: NCT02286713

PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening

Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.

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Key information

Conditions

Lung Cancer Behavior Health Behavior Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Smoking Cessation Thoracic Neoplasms Tobacco Use Cessation

Age range

55 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Information and Quality Healthcare (IQH)

Ridgeland, Mississippi, 39157, United States

About this study

This is the second phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (LDCT). The aim of this phase is to compare outcomes for promoting informed screening decisions about lung cancer screening in a randomized trial of patients who smoke recruited through state-based smoking cessation quitlines, where patients will be randomly assigned to the updated patient decision aid or to standard educational materials on lung cancer screening.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women 55 to 77 years of age.
  • Participants must speak English.
  • Current smoker or quit smoking within the past 15 years.
  • At least a 30 pack-year smoking history.

Exclusion criteria

  • History of lung cancer.

Treatment and study plan

Patient Decision Aid

Behavioral

Participants will receive study materials including a video to watch about lung cancer screening

Other names: Video, DVD

Standard Educational Information

Behavioral

Participants will receive study materials including a booklet to read about lung cancer screening.

Other names: Booklet

Follow-Up Assessments: Questionnaires

Behavioral

Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month

Other names: Survey

Primary outcomes

  1. Mean Value: Preparation for Decision Making© Scale

    Time frame: Assessment at 1-week follow-up.

    The Preparation for Decision Making© Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision. The scale is scored by summing the 10 items and dividing by 10. Scores are then converted to a 0-100 scale by subtracting 1 and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making. For this study, researchers used the patient version of the Preparation for Decision Making© scale, adapted for Lung Cancer Screening (LCS) context.

  2. Mean Value: Informed Subscale of the Decisional Conflict Scale©

    Time frame: Assessment at 1-week follow-up.

    A 3-item subscale that measures the degree to which the patient feels informed in making a decision about lung cancer screening. Total scores range from 0 (feels extremely informed) to 100 (feels extremely uninformed) related to making a decision. The scale was adapted for the LCS context.

  3. Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©

    Time frame: Assessment at 1-week follow-up.

    A 3-item subscale that measures the degree to which the patient feels clear about his or her values related to the lung cancer screening decision, including values about the harms and benefits. Total scores range from 0 (feels extremely clear about personal value for benefits and risks/side effects of screening) 100 (feels extremely unclear about personal value for benefits and risks/side effects of screening) related to making a decision. The scale was adapted for the LCS context.

Secondary outcomes

  1. Mean Value: Knowledge of Lung Cancer Screening

    Time frame: One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.

    A 12-item, self-report measure of the patient's knowledge of facts related to lung cancer and lung cancer screening, including the harms and benefits of testing. The knowledge scale yields a single score, representing the percentage of correct responses (ranging from 0% to 100% correct). Higher scores indicate greater knowledge.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2014
Registry last updated
Feb 1, 2021

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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