Decision Coaching for Lung Cancer Screening

Recruiting at 2 trial locations

Overseen By Rebecca Ayala

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Non-English speakers, Lung cancer history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

420 Participants Needed

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{1 6 10 11 12}

Research Team

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.

Exclusion Criteria

I am unable to understand and give informed consent.

I have a history of lung cancer.

I am currently pregnant.

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 Overview This 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

Group I: TELESCOPE intervention Experimental Treatment 1 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 Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an interactive video disk in breast cancer patient support. Maslin, AM., Baum, M., Walker, JS., et al.[2007]

Low-dose CT (LDCT) lung cancer screening is now covered for many at-risk patients, emphasizing the importance of counseling and shared decision-making about the risks and benefits of screening.

Behavioral economics highlights that patient biases can lead to flawed decision-making in lung cancer screening, suggesting that incorporating these insights into guidelines could improve patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising Approaches From Behavioral Economics to Improve Patient Lung Cancer Screening Decisions. Barnes, AJ., Groskaufmanis, L., Thomson, NB.[2017]

A group education class on lung cancer screening significantly improved participants' knowledge, with an average increase of 0.9 correct responses on a true-false quiz after the class, based on surveys from 680 participants.

Approximately 70% of participants felt they had enough information to make informed decisions about lung cancer screening after attending the class, indicating that this educational approach effectively enhances decision-making capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Patient Education Class to Enhance Knowledge about Lung Cancer Screening: a Quality Improvement Evaluation. Sakoda, LC., Meyer, MA., Chawla, N., et al.[2021]

In a study involving 237 lung cancer screening patients, both Option Grids and Shouldiscreen.com were effective in facilitating shared decision making (SDM), but Option Grids led to lower decision regret and better understanding of potential complications compared to Shouldiscreen.com.

Patients using Shouldiscreen.com reported less knowledge about complications and had higher decision regret regarding their choice to pursue screening, highlighting the importance of the decision aid used in the SDM process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aiding shared decision making in lung cancer screening: two decision tools. Sferra, SR., Cheng, JS., Boynton, Z., et al.[2021]

Decision coaching, when compared to usual care, significantly improved patient knowledge regarding health decisions, as shown in a subanalysis of 10 trials from the Cochrane Review of patient decision aids.

While decision coaching combined with patient decision aids (PtDAs) enhanced values-choice agreement and satisfaction in decision-making, it did not consistently outperform PtDAs alone in terms of knowledge or participation, indicating the need for further research to clarify its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision coaching to prepare patients for making health decisions: a systematic review of decision coaching in trials of patient decision AIDS. Stacey, D., Kryworuchko, J., Bennett, C., et al.[2022]

A telephone-based decision support program significantly increased the likelihood of eligible patients completing lung cancer screenings, demonstrating its effectiveness in a real-world primary care setting.

The study involved 829 eligible smokers, with 20 participants undergoing the intervention, highlighting the feasibility of using shared decision-making tools to enhance lung cancer screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-Based Shared Decision-making for Lung Cancer Screening in Primary Care. Fagan, HB., Fournakis, NA., Jurkovitz, C., et al.[2023]

The implementation of the DecisionPrecision tool was significantly more effective at sites that underwent the LEAP quality improvement training, with an average usage of 190.3 times over 6 months compared to just 3.5 times at standard sites, highlighting the importance of training in utilizing decision support tools.

Despite increased awareness of the tool's benefits from academic detailing visits, there was no significant increase in its use, indicating that for effective integration, such tools need to be fully automated and embedded in electronic health records to fit into the busy schedules of primary care physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Web-Based Tool for Shared Decision-making in Lung Cancer Screening: Mixed Methods Quality Improvement Evaluation. Lowery, J., Fagerlin, A., Larkin, AR., et al.[2023]

A qualitative study involving 36 clinicians and 49 patients revealed that shared decision-making about lung cancer screening is often not achieved, with clinicians varying in the information they provide and not consistently using decision aids.

Both clinicians and patients identified barriers such as time constraints, competing priorities, and limited patient understanding, which hinder effective communication and may leave patients unclear about the purpose and implications of lung cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Clinician Perspectives on Shared Decision-making in Early Adopting Lung Cancer Screening Programs: a Qualitative Study. Wiener, RS., Koppelman, E., Bolton, R., et al.[2019]

Implementing decision coaching for lung cancer screening significantly improved patient knowledge and perceptions of the shared decision-making process, with the implementation cohort showing greater understanding compared to the pre-implementation group (P < .01).

The decision coaching process was efficient, taking an average of 7.6 minutes without increasing overall visit time, and successfully addressed most of the required elements for shared decision-making as mandated by CMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Decision Coaching for Lung Cancer Screening in the Low-Dose Computed Tomography Setting. Lowenstein, LM., Godoy, MCB., Erasmus, JJ., et al.[2021]

The web-based decision aid significantly increased participants' knowledge about lung cancer risks and screening options, leading to improved understanding and reduced decisional conflict regarding screening choices.

After using the decision aid, participants showed better alignment with U.S. Preventive Services Task Force recommendations for lung cancer screening, indicating that the tool effectively supports informed decision-making for current and former smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. Lau, YK., Caverly, TJ., Cao, P., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of an Interactive On-line Tool on Therapeutic Decision-Making for Patients with Advanced Non-Small-Cell Lung Cancer. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Decision making in oncology: a review of patient decision aids to support patient participation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Using an interactive video disk in breast cancer patient support. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Promising Approaches From Behavioral Economics to Improve Patient Lung Cancer Screening Decisions. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a Patient Education Class to Enhance Knowledge about Lung Cancer Screening: a Quality Improvement Evaluation. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Aiding shared decision making in lung cancer screening: two decision tools. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Decision coaching to prepare patients for making health decisions: a systematic review of decision coaching in trials of patient decision AIDS. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Telephone-Based Shared Decision-making for Lung Cancer Screening in Primary Care. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Implementation of a Web-Based Tool for Shared Decision-making in Lung Cancer Screening: Mixed Methods Quality Improvement Evaluation. [2023]

10. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Implementing Decision Coaching for Lung Cancer Screening in the Low-Dose Computed Tomography Setting. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. [2018]