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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02286713
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 516
• Location: 1
• Arms: 2
• Actual Duration (Months): 70
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Smoking Cessation; Tobacco Use Cessation	Behavioral: Patient Decision Aid; Behavioral: Standard Educational Information; Behavioral: Follow-Up Assessments: Questionnaires	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 516 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Dec 30, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patient Decision Aid Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments	Behavioral: Patient Decision Aid; Participants will receive study materials including a video to watch about lung cancer screening; Other Names: Video DVD ; Behavioral: Follow-Up Assessments: Questionnaires; Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month; Other Names: Survey
Active Comparator: Standard Educational Information Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month Follow-up Assessments	Behavioral: Standard Educational Information; Participants will receive study materials including a booklet to read about lung cancer screening.; Other Names: Booklet ; Behavioral: Follow-Up Assessments: Questionnaires; Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month; Other Names: Survey

Outcome Measures

Primary Outcome Measures

1. Mean Value: Preparation for Decision Making© Scale [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© [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© [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 Outcome Measures

1. Mean Value: Knowledge of Lung Cancer Screening [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 77 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Men and women 55 to 77 years of age.

2. Participants must speak English.

3. Current smoker or quit smoking within the past 15 years.

4. At least a 30 pack-year smoking history.

Exclusion Criteria:

1. History of lung cancer.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Information and Quality Healthcare (IQH)	Ridgeland	Mississippi	United States	39157

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• Patient-Centered Outcomes Research Institute

Investigators

• Study Chair: Robert Volk, PhD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 28, 2016

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Official Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT02286713
• Other Study ID Numbers: 2014-0628; NCI-2014-02492; CER-1306-03385
• First Posted: Nov 10, 2014
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by M.D. Anderson Cancer Center: Lung Cancer Screening; heavy smokers; state-based smoking cessation quitlines; patient decision aid; low-dose computed tomography; LDCT; standard educational information
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

Participant Flow

Recruitment Details	Recruitment Period: March 2015 to September 2016 from tobacco quitline new and former callers.
Pre-assignment Detail	After consent participants completed baseline assessments prior to randomization.

Arm/Group Title	Patient Decision Aid	Standard Educational Information
Arm/Group Description	Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments	Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
Period Title: One Week Follow-Up
STARTED	259	257
COMPLETED	235	233
NOT COMPLETED	24	24
Period Title: One Week Follow-Up
STARTED	252	254
COMPLETED	224	228
NOT COMPLETED	28	26
Period Title: One Week Follow-Up
STARTED	250	252
COMPLETED	218	225
NOT COMPLETED	32	27

Baseline Characteristics

Arm/Group Title	Patient Decision Aid	Standard Educational Information	Total
Arm/Group Description	Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments	Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments	Total of all reporting groups
Overall Participants	259	257	516
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	190 73.4%	180 70%	370 71.7%
>=65 years	69 26.6%	77 30%	146 28.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.5 (5.0)	61.7 (5.8)	61.6 (5.4)
Sex: Female, Male (Count of Participants)
Female	157 60.6%	163 63.4%	320 62%
Male	102 39.4%	94 36.6%	196 38%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	2 0.8%	0 0%	2 0.4%
Asian	0 0%	0 0%	0 0%
Black or African American	62 23.9%	76 29.6%	138 26.7%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.4%	1 0.2%
Hispanic or Latino	7 2.7%	1 0.4%	8 1.6%
White	185 71.4%	177 68.9%	362 70.2%
Refused	0 0%	1 0.4%	1 0.2%
More than one race	1 0.4%	1 0.4%	2 0.4%
Other	2 0.8%	0 0%	2 0.4%
Region of Enrollment (participants) [Number]
United States	259 100%	257 100%	516 100%
Participant Pack-Year Smoking History (pack-years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [pack-years]	47.0	49.0	48.0
Participant Education Level (Count of Participants)
Less than High School	41 15.8%	36 14%	77 14.9%
Graduated high school/GED	72 27.8%	77 30%	149 28.9%
Some college/Trade school	107 41.3%	105 40.9%	212 41.1%
Graduated college or more	39 15.1%	39 15.2%	78 15.1%
Participant Health Insurance Status (Count of Participants)
Has insurance	239 92.3%	230 89.5%	469 90.9%
Does not have insurance	20 7.7%	27 10.5%	47 9.1%

Outcome Measures

1. Primary Outcome

Title	Mean Value: Preparation for Decision Making© Scale
Description	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.
Time Frame	Assessment at 1-week follow-up.

Outcome Measure Data

Analysis Population Description

Of participants providing data at the 1-week follow-up, seventeen(17) of the participants did not answer the scale items and were therefore dropped from analysis.

Arm/Group Title	Patient Decision Aid	Standard Educational Information
Arm/Group Description	Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments	Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
Measure Participants	227	224
Mean (Standard Deviation) [units on a scale]	79.4 (17.7)	69.4 (22.7)

2. Primary Outcome

Title	Mean Value: Informed Subscale of the Decisional Conflict Scale©
Description	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.
Time Frame	Assessment at 1-week follow-up.

Outcome Measure Data

Analysis Population Description

All participants providing data at the 1-week follow-up where one participant in the Decision Aid Arm did not answer the scale questions and was dropped from the analysis.

Arm/Group Title	Patient Decision Aid	Standard Educational Information
Arm/Group Description	Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments	Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
Measure Participants	234	233
Mean (Standard Deviation) [units on a scale]	27.1 (25.9)	42.1 (30.8)

3. Primary Outcome

Title	Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©
Description	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.
Time Frame	Assessment at 1-week follow-up.

Outcome Measure Data

Analysis Population Description

Of participants providing data at the 1-week follow-up, one participant in the Standard Educational Information group did not answer the Values Clarity Subscale questions and was dropped from the analysis and where one participant in the Decision Aid Arm did not answer the scale questions and was dropped from the analysis.

Arm/Group Title	Patient Decision Aid	Standard Educational Information
Arm/Group Description	Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments	Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
Measure Participants	234	232
Mean (Standard Deviation) [units on a scale]	17.6 (26.2)	31.7 (32.8)

4. Secondary Outcome

Title	Mean Value: Knowledge of Lung Cancer Screening
Description	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.
Time Frame	One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.

Outcome Measure Data

Analysis Population Description

For the participants providing data at the 1-week follow-up, no data was missing in either group.

Arm/Group Title	Patient Decision Aid	Standard Educational Information
Arm/Group Description	Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments	Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
Measure Participants	235	233
One-week	57.5 (21.8)	40.1 (17.1)
3-Months	44.4 (19.6)	35.9 (16.9)
6-Months	49.9 (17.8)	40.0 (18.1)

Adverse Events

Time Frame	Adverse event data collected through 6 months participation.
Arm/Group Title	Patient Decision Aid		Standard Educational Information
Arm/Group Description	Decision Aid study materials including video mailed to participant with 1-week, 3-month, and 6-month follow-up assessments		Study materials including education booklet mailed to participant with 1-week, 3-month, and 6-month follow-up assessments
All Cause Mortality
	Patient Decision Aid		Standard Educational Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/259 (1.5%)		1/257 (0.4%)
Serious Adverse Events
	Patient Decision Aid		Standard Educational Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/259 (0%)		0/257 (0%)
Other (Not Including Serious) Adverse Events
	Patient Decision Aid		Standard Educational Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/259 (0%)		0/257 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.