Survivorship Care for Lung Cancer

(KYLEADSII Trial)

Overseen By Jerod L Stapleton, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jerod L Stapleton, PhD

Disqualifiers: Psychiatric disturbance, Substance abuse, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the quality of life for lung cancer survivors. It compares the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program, a special care program for survivors, with enhanced usual care, which includes reading materials and assessments. The goal is to determine which approach better supports survivors in managing lung cancer stigma and engaging with ongoing care. The trial seeks lung cancer survivors who live in rural areas and can communicate in English. As an unphased trial, it offers a unique opportunity for survivors to contribute to research that could enhance care programs for others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program focuses on improving life quality for lung cancer survivors. This program helps survivors manage symptoms and stay engaged in their care.

While specific safety details aren't available, it's important to note that this is a care program, not a medication or surgery. It likely emphasizes patient-focused care, shared decision-making, and motivational support, which are generally safe and aim to aid survivors in their recovery.

The program aims to lessen the impact of lung cancer, and sources provided report no negative effects related to its use. Therefore, it appears to be a safe choice for those seeking to enhance their quality of life after lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) because it emphasizes patient-centered care by incorporating shared decision-making and motivational interviewing. Unlike traditional post-treatment care, which often follows a one-size-fits-all approach, KLCLCSC tailors interventions to individual needs, aiming to boost survivor engagement and improve outcomes. This approach represents a shift towards more personalized and proactive cancer survivorship strategies, potentially setting a new standard in lung cancer care.

What evidence suggests that this trial's treatments could be effective for improving lung cancer quality of life?

Research has shown that the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program, a treatment arm in this trial, aims to enhance life for lung cancer survivors. The program emphasizes personalized care and employs motivational conversations to help patients manage their health more effectively. Early results suggest this method can improve symptom control and quality of life. Studies indicate that these customized approaches significantly lessen the impact of lung cancer. The program also addresses issues like the stigma surrounding lung cancer, helping survivors feel more supported and confident in their health journey. ^{1 2 5 6 7}

Who Is on the Research Team?

Jamie L Studts, PhD

Principal Investigator

University of Colorado School of Medicine

Jerod L Stapleton, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been diagnosed with lung cancer and live in a rural area (RUC code of 4+). They must be able to communicate in English. There's no mention of specific exclusions, so it seems open to many lung cancer survivors.

Inclusion Criteria

Be able to communicate effectively in English

Reside in a rural county as determined by a RUC code of 4 or higher

I have been diagnosed with lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) or Enhanced Usual Care (EUC) for 6 months

6 months

Follow-up

Participants are monitored for changes in quality of life, engagement, and other outcomes after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program

Trial Overview The study compares the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program, which aims to improve quality of life and engagement with care, against enhanced usual care involving bibliotherapy and assessment.

How Is the Trial Designed?

Group I: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) Experimental Treatment 1 Intervention

The Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) is a targeted and tailored lung cancer survivorship care intervention built on principles of patient-centered care, shared decision making, and motivational interviewing to build survivor engagement and improve lung cancer outcomes.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

The enhanced usual care condition involves usual care plus bibliotherapy and assessment.

Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program is already approved in United States for the following indications:

Approved in United States as Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program for:

• Lung cancer survivorship care

Who Is Running the Clinical Trial?

Jerod L Stapleton, PhD

Lead Sponsor

Trials

3

Recruited

760+

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

G02 for Lung Cancer

Collaborator

Trials

1

Recruited

300+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

University of Louisville

Collaborator

Trials

353

Recruited

76,400+

Published Research Related to This Trial

The Robert H Lurie Comprehensive Cancer Center successfully implemented cancer survivorship care plans (SCPs) for patients completing primary cancer treatment, utilizing clinician and patient feedback to create customized templates that streamline the process.

The SCP templates significantly reduced the time clinicians spent completing them, averaging just 12 minutes, and auto-populated 20% of the required fields, enhancing efficiency and supporting better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship care planning in a comprehensive cancer center using an implementation framework. Garcia, SF., Kircher, SM., Oden, M., et al.[2016]

The Thoracic Survivorship Program, run by nurse practitioners, showed high patient compliance with follow-up care, with only 2.7% of visits being noncompliant compared to 3.6% in the surgeon-only follow-up group.

Enrollment in the Thoracic Survivorship Program was linked to significantly improved disease-free survival rates, with a hazard ratio of 0.57, indicating that patients in this program had better long-term outcomes compared to those receiving standard follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. Keshava, HB., Tan, KS., Dycoco, J., et al.[2023]

Among 832 long-term lung and colorectal cancer survivors, those who received both elements of survivorship care planning (SCP) reported significantly better health outcomes, including improved communication with physicians and higher likelihood of follow-up care.

Receiving a written summary of cancer treatment and instructions for routine follow-up was associated with better physical health and self-perceived health status, indicating that effective SCP can enhance long-term survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship care planning and its influence on long-term patient-reported outcomes among colorectal and lung cancer survivors: the CanCORS disease-free survivor follow-up study. Chrischilles, EA., McDowell, BD., Rubenstein, L., et al.[2018]

The National Cancer Survivorship Resource Center, established in 2010, focuses on improving the health and quality of life for cancer survivors by developing comprehensive follow-up care guidelines.

These guidelines will not only monitor for cancer recurrence but also address long-term physical and psychosocial effects of cancer treatment, promoting healthy behaviors to reduce the risk of future cancers and chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing survivorship care through the National Cancer Survivorship Resource Center: developing American Cancer Society guidelines for primary care providers. Cowens-Alvarado, R., Sharpe, K., Pratt-Chapman, M., et al.[2022]

Rural primary care providers (PCPs) face significant barriers in delivering cancer survivorship care, including organizational challenges, unclear roles with specialists, and a lack of knowledge about survivorship guidelines, as identified in focus groups with seven PCP teams.

An interdisciplinary training program called iSurvive was developed and tested, leading to changes in practice among PCPs to better identify and provide evidence-based care for cancer survivors, highlighting the need for improved collaboration between oncology and primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing the delivery of cancer survivorship care in rural primary care practice. Klemp, JR., Knight, CJ., Lowry, B., et al.[2022]

A systematic review of 11 studies, including 8 randomized controlled trials, found that the shared care model for cancer survivors is as effective as usual care in terms of quality of life and clinical outcomes, while also being highly acceptable to patients and practitioners.

Patient satisfaction with shared care was reported to be higher than with usual care, suggesting that improved communication between primary and hospital care can enhance follow-up for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. Zhao, Y., Brettle, A., Qiu, L.[2022]

The analysis of 149 breast cancer survivorship care plans (SCPs) revealed that while demographic and treatment information was mostly complete, follow-up recommendations were inconsistent, with significant gaps in post-treatment symptom management and surveillance plans.

Only 15% of women on aromatase inhibitors received guideline-concordant recommendations for bone density testing, highlighting the need for improvements in follow-up care to align with established cancer care guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer survivorship care plans: what are they covering and how well do they align with national guidelines? Choi, Y., Smith, KC., Shukla, A., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02989974

Kentucky LEADS Collaborative: Lung Cancer Survivorship ... The investigators hypothesize that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved quality of life, better symptom control, ...

2. hsc.wvu.edu hsc.wvu.edu/media/13651/kentucky-leads-collaborative-lung-cancer-survivorship-program.pdf

kentucky-leads-collaborative-lung-cancer-survivorship- ... “Dedicated to reducing the burden of lung cancer in Kentucky and beyond through development, evaluation and dissemination of novel, community-.

3. cph.uky.edu cph.uky.edu/research/projects/precision-lung-cancer-survivorship-care-intervention

Precision Lung Cancer Survivorship Care Intervention The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative ...

4. lungcancerpolicynetwork.com lungcancerpolicynetwork.com/advancing-lung-cancer-screening-in-kentucky/

Advancing lung cancer screening initiatives in Kentucky Through the Kentucky LEADS Collaborative, the state has become a national leader in lung cancer screening participation, with a rate of 13.7% in ...

5. jto.org jto.org/article/S1556-0864(16)33416-5/fulltext

P3.05-013 Development of the Kentucky LEADS ... Approximately 300 lung cancer survivors and caregivers are completing three waves of validated patient-reported outcome measures and program acceptability ...

6. ukhealthcare.uky.edu ukhealthcare.uky.edu/markey-cancer-center/research/csri

Cancer Survivorship Research Initiative - UK HealthCare 234 patients will be enrolled in this trial. Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program PI: Jamie Studts, PhD (University of Colorado, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05857995

Precision Lung Cancer Survivorship Care Intervention The project involves a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care ...