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| Name | Class |
|---|---|
| New Jersey Commission on Cancer Research | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TELESCOPE intervention | Experimental | Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. If a participant is a current smoker then they are offered and navigated to evidence-based smoking cessation. If the participant is interested in screening, an LDCT is ordered. Support for screening, diagnostic testing and oncology care will be provided as needed from the Nurse Navigators. |
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| Enhanced Usual Care | No Intervention | Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. Primary and secondary outcome data related to the office visit will be collected. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The investigators expect a recruitment rate of ≥60%. | 1 week post-intervention |
| 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. | 1 week post-intervention |
| Follow-up completion rate | The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments | 1 week post-intervention |
| Intervention Fidelity Rate | The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators. | 1 week post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post-intervention |
| To assess shared decision making quality |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco treatment referral | Medical records will be reviewed at 3 months post-intervention to determine if a tobacco treatment referral has been generated. | 3 months post-intervention |
| Receipt of tobacco treatment |
Inclusion Criteria:
Aim 1 (Cultural Adaptation):
To be eligible, patients must:
Aims 2-3 (Pilot Randomized Controlled Trial)
To be eligible, patients must:
Interviews
Providers completing the semi-structured interviews will be:
Online surveys
Providers completing online PRISM construct surveys will be:
Exclusion Criteria:
For the cluster randomized trial, excluded will be patients who:
Providers/administrators will be excluded if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evelyn Arana, DrPH | Contact | 9086420861 | earana@cinj.rutgers.edu | |
| Arlette Chavez-Iniguez, MD | Contact | (732)715-4923 | ac2758@CINJ.Rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Evelyn Arana, DrPH | Rutgers Cancer Institute of NJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D061351 | Telescopes |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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The investigators will conduct three focus groups and interviews to culturally adapt the intervention materials for a heterogeneous Hispanic population (Aim 1). After the intervention is culturally adapted, clinicians serving large numbers of Hispanic patients will be the unit of randomization (Aims 2-3). The investigators will randomize 1:1 clinicians to the culturally adapted intervention (TELESCOPE) versus enhanced usual care (EUC). Patients of clinicians will all be assigned to the arm to which the clinician was assigned.
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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. |
| 1 week post-intervention |
| 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. | 12 months post-intervention |
| 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. | 12 months post-intervention |
| Intervention Appropriateness (Clinicians) | 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. | Post-intervention |
Medical records will be reviewed at 3 months post-intervention to determine if the patient has undergone tobacco treatment.
| 3 months post-intervention |
| 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). | Baseline and 1-week post-intervention |
| 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. | Baseline and 1-week post-intervention |
| Medical Mistrust | 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. | Baseline and 1-week post-intervention |
| Telehealth Patient Satisfaction | 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. | 1-week post-intervention |