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.
Have been diagnosed with lung cancer
Reside in a rural county as determined by a Rural Urban Continuum Code (RUC) of 4 or higher
Be at least 18 years of age or older
Be able to communicate effectively in English
Have significant psychiatric disturbance that requires a higher level of care
Have substance abuse/dependence that requires a higher level of care
Are participating in another lung cancer survivorship care intervention
Have previously participated in the Kentucky LEADS Lung Cancer Survivorship Care Program
Parallel
Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program
BehavioralKLCLCSC is a survivor or survivor plus caregiver-focused psychosocial and behavioral intervention designed to engage lung cancer survivors and improve lung cancer outcomes.
Enhanced Usual Care
BehavioralEUC involves a combination of the standard of care plus a bibliotherapy intervention and assessment.
Change from Baseline (T0) in Mean Lung Cancer Quality of Life at 6 Months (T2)
The Functional Assessment of Cancer Therapy-Lung (FACT-L) is a 36-item self-report instrument that measures quality life. Scores range from 0 to 144 with higher scores indicating better quality of life.
Change from Baseline (T0) in Total Survivor Engagement at 6 Months (T2)
The Patient Activation Measure (PAM) is a standardized 13-item self-report measure of patient engagement with a theoretical range of 0 to 100 with higher scores indicating greater engagement.
Change from Baseline (T0) in Mean Lung Cancer Knowledge at 6 Months (T2)
The Perceived Knowledge of Lung Cancer Scale is a 6-item intervention-specific measure of self-reported/perceived knowledge of lung cancer and survivorship developed for this research program. Scores range from 0 to 24 with higher scores indicating greater knowledge.
Change from Baseline (T0) in Mean Fatigue Symptoms at 6 Months (T2)
Fatigue Symptoms is a standardized 5-item self-report measure of fatigue within the Patient-Reported Outcomes Measurement Information System (PROMIS-Fatigue). Scores range from 0 to 20 with higher scores indicating better quality of life and lesser fatigue symptoms.
Change from Baseline (T0) in Mean Sleep Disturbance at 6 Months (T2)
Sleep Disturbance is a standardized 6-item self-report measure of sleep disruption within the Patient-Reported Outcomes Measurement Information System (PROMIS-Sleep). Scores range from 0 to 20 with higher scores indicating better quality of life and lesser seep disturbance.
Click on the lead sponsor to view all of their trials.
Jerod L Stapleton, PhD
Lead sponsor
University of Kentucky
Sponsor institution
University of Louisville
Collaborator
G02 for Lung Cancer
Collaborator
National Cancer Institute (NCI)
Collaborator
