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NCT Number: NCT07165691

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

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.

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Key information

Age range

50 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

Location status: Recruiting

Location contact

Evelyn Arana, DrPH

CONTACT

[email protected]

908-642-0861

Evelyn Arana, DrPH

PRINCIPAL_INVESTIGATOR

About this study

This pilot feasibility trial aims to culturally adapt an existing TELESCOPE (R01HL158850) intervention to create a culturally appropriate SDM and navigation intervention for Hispanics in primary care settings. The investigators will assess its feasibility and acceptability (primary outcomes), and explore its impact on the uptake of LDCT (secondary outcome) compared to enhanced usual care (training clinicians to discuss LCS) for LCS in Hispanics.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Aim 1 (Cultural Adaptation):

To be eligible, patients must:

  • 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
  • Have at least a 20-pack-year smoking history

Aims 2-3 (Pilot Randomized Controlled Trial)

To be eligible, patients must:

  • Identify as Hispanic or Latino(a)
  • Able to speak and read in English or Spanish
  • Be 50 to 77 years of age
  • Be a current or former smoker having quit within the past 15 years
  • Have at least a 20 pack-year smoking history
  • Be scheduled for a non-acute care visit at one of the study sites.
  • Not coughing up blood in the last two weeks

Interviews

Providers completing the semi-structured interviews will be:

  • A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator at one of the participating sites, or a TELESCOPE study patient navigator and nurse navigator
  • Age 18 or older
  • Fluent in English

Online surveys

Providers completing online PRISM construct surveys will be:

  • A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator
  • Age 18 or older
  • Fluent in English

Exclusion criteria

For the cluster randomized trial, excluded will be patients who:

  • 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
  • Has been coughing up blood in the last two weeks
  • Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider,
  • Are unable to provide informed consent Interviews

Providers/administrators will be excluded if they:

  • Are unable to provide informed consent Online surveys
  • Are unable to provide informed consent
  • Women who are pregnant.

Treatment and study plan

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

Primary outcomes

  1. Recruitment rate

    Time frame: 1 week post-intervention

    The investigators expect a recruitment rate of ≥60%.

  2. Participant Acceptability

    Time frame: 1 week post-intervention

    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.

  3. Follow-up completion rate

    Time frame: 1 week post-intervention

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

  4. Intervention Fidelity Rate

    Time frame: 1 week post-intervention

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

Secondary outcomes

  1. Rate of participants that have completed LDCT

    Time frame: 3 months post-intervention

    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.

  2. To assess shared decision making quality

    Time frame: 1 week post-intervention

    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.

  3. Feasibility of intervention (Clinicians)

    Time frame: 12 months post-intervention

    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.

  4. Clinicians Acceptability

    Time frame: 12 months post-intervention

    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.

  5. Intervention Appropriateness (Clinicians)

    Time frame: Post-intervention

    The Intervention Appropriateness Measure (IAM) will be completed by clinicians. The total score for each instrument ranges from 4 to 20, with higher scores indicating greater acceptability.

Other outcomes

  1. Tobacco treatment referral

    Time frame: 3 months post-intervention

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

  2. Receipt of tobacco treatment

    Time frame: 3 months post-intervention

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

  3. Cancer Fatalism

    Time frame: Baseline and 1-week post-intervention

    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).

  4. Decisional Conflict

    Time frame: Baseline and 1-week post-intervention

    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.

  5. Medical Mistrust

    Time frame: Baseline and 1-week post-intervention

    The Medical Mistrust Index is a valid and reliable 7-item self-report measure (Cronbach's alpha = 0.76). Participants are asked to rate their agreement with each of the statements on a 4-point Likert scale, ranging from strongly disagree to strongly agree. Scores range from 7 to 28 with higher scores indicating more mistrust.

  6. Telehealth Patient Satisfaction

    Time frame: 1-week post-intervention

    The investigators will assess patient satisfaction with how the telehealth visit/telephone call with the navigator went for them. Participants are asked 6 questions to determine their perception of the overall quality of their telehealth visit. Response categories for each item are on a 5-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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arlette Chavez-Iniguez, MD

CONTACT

[email protected]

(732)715-4923

Evelyn Arana, DrPH

CONTACT

[email protected]

9086420861

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • New Jersey Commission on Cancer Research

Registry information

Acronym: TELESCOPE-H

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2025
Registry last updated
Dec 2, 2025

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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