420 Participants Needed

Decision Coaching for Lung Cancer Screening

Recruiting at 2 trial locations
AY
SF
JE
RA
Overseen ByRebecca Ayala
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict. Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers. Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Remote Decision Coaching with Navigation Intervention for lung cancer screening?

Research shows that decision aids and coaching can help patients make better decisions by increasing their involvement and understanding, which is important for complex choices like lung cancer screening. Studies have found that patients using decision aids are more likely to participate in decision-making and make higher-quality decisions.12345

Is Decision Coaching for Lung Cancer Screening safe for humans?

The research articles do not provide specific safety data for Decision Coaching for Lung Cancer Screening or its related interventions. They focus on the effectiveness and feasibility of shared decision-making tools rather than safety outcomes.46789

How is the TELESCOPE treatment different from other lung cancer screening treatments?

The TELESCOPE treatment is unique because it involves remote decision coaching and navigation to support shared decision-making (a process where patients and healthcare providers make decisions together) for lung cancer screening, which is not commonly emphasized in traditional screening methods.16101112

Research Team

AY

Anita Y Kinney, PhD, RN

Principal Investigator

Rutgers Cancer Institute

Eligibility Criteria

The TELESCOPE trial is for English-speaking adults aged 50-77 who have a significant smoking history (at least 20 pack-years) and are either current smokers or quit within the last 15 years. They must be due for a non-emergency medical visit but not pregnant, without lung cancer history, nor screened for it in the past year. Health providers involved need to work at participating sites.

Inclusion Criteria

I am 18 years old or older.
You must have smoked in the past or have quit smoking within the last 15 years.
I am fluent in English.
See 7 more

Exclusion Criteria

I am unable to understand and give informed consent.
I have a history of lung cancer.
I am currently pregnant.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive navigator decision coaching or enhanced usual care for lung cancer screening

3 months
Baseline survey and follow-up at one week after primary care visit

Follow-up

Participants are monitored for adherence to lung cancer screening and smoking cessation referrals

5 years

Treatment Details

Interventions

  • Remote Decision Coaching with Navigation Intervention
  • TELESCOPE
Trial OverviewThis study tests if remote decision coaching with navigation intervention (TELESCOPE) improves shared decision-making in lung cancer screening compared to usual care. It aims to increase knowledge about screening, encourage more discussions, and boost adherence to repeat screenings and smoking cessation referrals.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TELESCOPE interventionExperimental Treatment1 Intervention
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.
Group II: Enhanced usual care (EUC)Active Control1 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.

Remote Decision Coaching with Navigation Intervention is already approved in United States for the following indications:

🇺🇸
Approved in United States as Remote Decision Coaching with Navigation for:
  • Lung Cancer Screening Decision Support

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

An online decision tool developed for advanced non-small-cell lung cancer significantly influenced treatment choices among 442 participating physicians, with expert feedback impacting decisions in 73% of cases.
The tool was particularly effective for cases involving ALK fusions, where participants were 2.5 times more likely to adopt expert-recommended therapies compared to cases with EGFR mutations, highlighting the importance of tailored treatment recommendations.
Impact of an Interactive On-line Tool on Therapeutic Decision-Making for Patients with Advanced Non-Small-Cell Lung Cancer.Chow, H., Edelman, MJ., Giaccone, G., et al.[2016]
A systematic review of 23 randomized trials found that cancer patient decision aids significantly improve patient participation in decision making and lead to higher-quality decisions regarding treatment options.
Effective strategies to enhance shared decision making include training clinicians, using question prompt sheets, and providing decision coaching, which can help address patients' knowledge gaps and unrealistic expectations.
Decision making in oncology: a review of patient decision aids to support patient participation.Stacey, D., Samant, R., Bennett, C.[2022]
The randomized-controlled trial found that using an interactive video disk (IVD) for decision-making did not significantly change treatment choices for women recently diagnosed with breast cancer, indicating that the support from clinical staff is more impactful.
Despite the lack of effect on treatment decisions, participants rated the IVD positively, suggesting it could standardize information delivery, promote evidence-based practices, and serve as a quality assurance tool.
Using an interactive video disk in breast cancer patient support.Maslin, AM., Baum, M., Walker, JS., et al.[2007]

References

Impact of an Interactive On-line Tool on Therapeutic Decision-Making for Patients with Advanced Non-Small-Cell Lung Cancer. [2016]
Decision making in oncology: a review of patient decision aids to support patient participation. [2022]
Using an interactive video disk in breast cancer patient support. [2007]
Promising Approaches From Behavioral Economics to Improve Patient Lung Cancer Screening Decisions. [2017]
Effectiveness of a Patient Education Class to Enhance Knowledge about Lung Cancer Screening: a Quality Improvement Evaluation. [2021]
Aiding shared decision making in lung cancer screening: two decision tools. [2021]
Decision coaching to prepare patients for making health decisions: a systematic review of decision coaching in trials of patient decision AIDS. [2022]
Telephone-Based Shared Decision-making for Lung Cancer Screening in Primary Care. [2023]
Implementation of a Web-Based Tool for Shared Decision-making in Lung Cancer Screening: Mixed Methods Quality Improvement Evaluation. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Patient and Clinician Perspectives on Shared Decision-making in Early Adopting Lung Cancer Screening Programs: a Qualitative Study. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Implementing Decision Coaching for Lung Cancer Screening in the Low-Dose Computed Tomography Setting. [2021]
Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. [2018]