TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-77
SponsorRutgers, The State University of New Jersey

About this trial

Aim 1: Culturally adapt the TELESCOPE intervention for Hispanics. Using iterative qualitative feedback from a study-specific Community Advisory Board, focus groups, and interviews with community members, the investigators will culturally adapt the TELESCOPE intervention for Hispanics at high risk for lung cancer.

Aim 2: Assess the feasibility, acceptability, and implementation potential of the culturally adapted TELESCOPE intervention delivered by bilingual patient navigators for Hispanics. Hypothesis 1: The investigators expect a recruitment rate of ≥60%, ≥90% of Hispanic participants will complete the 1-week follow-up assessments, ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators, and ≥90% of participants and clinicians will agree or completely agree that the intervention was feasible and acceptable.

Aim 3: Explore the impact of a culturally adapted TELESCOPE intervention delivered by bilingual patient navigators vs enhanced usual care (EUC) on the initial uptake of low-dose computed tomography (LDCT) and quality of the shared decision-making (SDM) process. Hypothesis 2: The investigators expect that an adapted TELESCOPE intervention will result in higher uptake of LDCT and higher SDM quality for lung cancer screening (LCS) compared to EUC.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Identify as Hispanic and/or Latino(a)

Able to read and speak in English or Spanish

Be 50 to 77 years of age

Be a current or former smoker

Disqualifiers

Do not speak English

Are not Hispanic or Latino(a)

Have a history of lung cancer

Had a CT scan in the past 12 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • TELESCOPE, Remote Decision Coaching with Navigation Intervention

    Behavioral

    The TELESCOPE intervention involves three complementary components: 1) decision aid and coaching for LCS, 2) referral of current smokers to evidence-based smoking cessation services, and 3) for participants interested in screening, navigation to complete LCS and diagnostic testing and oncology care as needed

Treatment groups

91 Participants
are divided into 2 treatment groups
Group A: TELESCOPE interventionExperimental treatment 1 intervention
Group B: Enhanced Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

The investigators expect a recruitment rate of ≥60%.

Time frame
1 week post-intervention
2

Participant Acceptability

The Ottawa Acceptability Measure will assess the acceptability of the TELESCOPE intervention from the patient's perspective at 1-week post-intervention. There is no total score for this measure. Responses will be reported descriptively in terms of proportions responding positively or negatively for each criteria.

Time frame
1 week post-intervention
3

Follow-up completion rate

The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments

Time frame
1 week post-intervention
4

Intervention Fidelity Rate

The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.

Time frame
1 week post-intervention

Secondary outcomes

1

Rate of participants that have completed LDCT

The investigators will assess the rates of completion of LDCT at 3 months post-intervention for all participants. This will be abstracted from patients' medical records.

Time frame
3 months post-intervention
2

To assess shared decision making quality

This will be assessed with the Shared Decision-Making Process Survey (SDM Process\_4), which is a 4-item performance measure of the process and outcome of shared decision making. Scores range from 0 to 4, with higher scores indicating a better process.

Time frame
1 week post-intervention
3

Feasibility of intervention (Clinicians)

The feasibility of the intervention (FIM) measure will be completed by clinicians. The total score for this instrument ranges from 4 to 20, with higher scores indicating greater feasibility.

Time frame
12 months post-intervention
4

Clinicians Acceptability

The acceptability of the intervention (AIM) will be completed by clinicians. The total score ranges from 4 to 20, with higher scores indicating greater acceptability.

Time frame
12 months post-intervention

Other outcomes

1

Tobacco treatment referral

Medical records will be reviewed at 3 months post-intervention to determine if a tobacco treatment referral has been generated.

Time frame
3 months post-intervention
2

Receipt of tobacco treatment

Medical records will be reviewed at 3 months post-intervention to determine if the patient has undergone tobacco treatment.

Time frame
3 months post-intervention
3

Cancer Fatalism

The investigators will assess cancer fatalism by asking participants to rate how much they agree or disagree with 3 items: 1) It seems like everything causes cancer, 2) There's not much participants can do to lower their chances of getting cancer, and 3) There are so many recommendations about preventing cancer, it's hard to know which ones to follow. Response categories for each item are on a four-point scale ranging from strongly agree to strongly disagree. There is no total score for this survey. Responses will be reported descriptively for each question. This measure has shown good internal consistency (Cronbach's alpha = 0.60).

Time frame
Baseline and 1-week post-intervention
4

Decisional Conflict

The Decisional Conflict Scale is a widely used measure of the degree to which a patient feels clear about the options and sure about the choice they make. The scale is scored from 0 to 100, with scores under 25 being associated with implementing decisions, while scores above 37.5 suggest delays in decision making.

Time frame
Baseline and 1-week post-intervention

Sponsors and contacts

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Rutgers, The State University of New Jersey

Lead sponsor

New Jersey Commission on Cancer Research

Collaborator