Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Lung Cancer

Treatments: Other: Cognitive Interviews; Other: Focus groups; Behavioral: Colon cancer screening video; Other: Surveys; Behavioral: Lung cancer screening decision aid video

Study type: Interventional

Funder types: Other

Identifiers

NCT07382557

2022-0383

Details and patient eligibility

About

The goal of the study is to adapt and test a participant decision aid about lung cancer screening for use with patients in theHarris Health System (HHS).

Full description

The study has two phases. In the first phase, the investigators will conduct a cultural and linguistic adaptation of a patient decision aid video on lung cancer screening for use with patients with low health literacy in English and Spanish. They will produce adapted decision aid videos and written educational materials about lung cancer screening. They will survey providers about their lung cancer screening practices, conduct focus groups to learn what patients want to know about screening, and perform cognitive interviews with patients to make sure the adapted videos and educational materials are easy to understand.

In the second phase, the investigators will test the adapted lung cancer screening decision aid videos in English and Spanish to determine acceptability and impact of the aids on decision making outcomes. Patients will be randomized to evaluate an adapted video decision aid intervention or a control condition.

Enrollment: 360 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. 50-80 years of age
2. Current smokers or smokers who have quit less than 15 years ago
3. Speak either English or Spanish
4. No history of lung cancer
5. Family member of someone with a history of smoking AND lung cancer

Exclusion Criteria:

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 5 patient groups, including a placebo group

Needs Assessment: Provider Survey (Aim 1)

Other group

Description:

Up to 200 physicians and other health professionals

Treatment:

Other: Surveys

Needs Assessment: Patient/Family member Focus Groups (Aim 1)

Other group

Description:

Up to 20 participants who speak English or Spanish

Treatment:

Other: Focus groups

Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1)

Other group

Description:

Up to 40 participants who speak English or Spanish

Treatment:

Other: Cognitive Interviews

Pilot Study: Intervention Patients (Aim 2)

Experimental group

Description:

Up to 50 participants (25 English speakers, 25 Spanish speakers)

Treatment:

Behavioral: Lung cancer screening decision aid video

Pilot Study: Control Patients (Aim 2)

Placebo Comparator group

Description:

Up to 50 participants (25 English speakers, 25 Spanish speakers)

Treatment:

Behavioral: Colon cancer screening video