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?

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 survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. The project involves a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes.

Will I have to stop taking my current medications?

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

How is the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program treatment different from other treatments for lung cancer?

The Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program is unique because it focuses on survivorship care planning, which includes creating personalized care plans for patients who have completed primary cancer treatment. This approach emphasizes long-term follow-up and management of both physical and psychosocial effects of cancer, aiming to improve overall quality of life for lung cancer survivors. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Enhanced Usual Care, Duphalac, Kristalose, Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program, KLCLCSC, Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program for lung cancer?

Research shows that survivorship care planning (SCP) can improve health outcomes for cancer survivors, including those with lung cancer. The implementation of SCPs has been supported by both clinicians and patients, indicating their potential effectiveness in improving long-term care and follow-up compliance. ^{1 2 3 6 7}

Who Is on the Research Team?

Jerod L Stapleton, PhD

Principal Investigator

University of Kentucky

Jamie L Studts, PhD

Principal Investigator

University of Colorado School of Medicine

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

I have been diagnosed with lung cancer.

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

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 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 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]

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]

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]

Citations

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

Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. [2023]

2. United States 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. [2018]

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

Survivorship care planning in a comprehensive cancer center using an implementation framework. [2016]

4. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Breast cancer survivorship care plans: what are they covering and how well do they align with national guidelines? [2020]

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

Advancing survivorship care through the National Cancer Survivorship Resource Center: developing American Cancer Society guidelines for primary care providers. [2022]

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

Informing the delivery of cancer survivorship care in rural primary care practice. [2022]