300 Participants Needed

Survivorship Care for Lung Cancer

(KYLEADSII Trial)

CR
JK
KH
JL
Overseen ByJerod L Stapleton, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jerod L Stapleton, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

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

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.12345

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.12367

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.

Research Team

JL

Jerod L Stapleton, PhD

Principal Investigator

University of Kentucky

JL

Jamie L Studts, PhD

Principal Investigator

University of Colorado School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC)Experimental Treatment1 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 Control1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. [2023]
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]
Survivorship care planning in a comprehensive cancer center using an implementation framework. [2016]
The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. [2022]
Breast cancer survivorship care plans: what are they covering and how well do they align with national guidelines? [2020]
Advancing survivorship care through the National Cancer Survivorship Resource Center: developing American Cancer Society guidelines for primary care providers. [2022]
Informing the delivery of cancer survivorship care in rural primary care practice. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security