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Precision Lung Cancer Survivorship Care Intervention (KYLEADSII)

J

Jerod L Stapleton, PhD

Status

Enrolling

Conditions

Cancers, Lung
Cancer of Lung
Cancer of the Lung
Pulmonary Cancer
Pulmonary Neoplasms
Lung Cancer
Cancers, Pulmonary
Pulmonary Cancers
Lung Cancers
Cancer, Lung
Neoplasms, Pulmonary
Neoplasm, Pulmonary
Neoplasms, Lung
Pulmonary Neoplasm
Cancer, Pulmonary

Treatments

Behavioral: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program
Behavioral: Enhanced Usual Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05857995
R01CA254734 (U.S. NIH Grant/Contract)
94571

Details and patient eligibility

About

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.

Full description

Among the devastating illnesses impacting rural America, few exact the physical, social, psychological, and economic toll of lung cancer. Lung cancer is the leading cause of cancer death in rural America, and the levy is particularly acute in Kentucky - a state that not only leads the nation in lung cancer incidence and mortality but is a global epicenter of lung cancer. Despite the prevailing nihilism regarding lung cancer care, lung cancer survivors are living longer. Innovations in prevention, early detection, and treatment, have created substantial optimism and opportunities for long-term lung cancer survivorship. These dramatic changes in the lung cancer care landscape have invigorated the need for quality lung cancer survivorship interventions. 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. Using a novel precision survivorship approach and developed in collaboration with rural community stakeholders, the program's foundation incorporates principles of patient-centered care, shared decision making, and motivational interviewing to build survivor engagement. A large acceptability and feasibility trial conducted in collaboration with nine lung cancer care facilities in Kentucky with lung cancer survivors (N=140) demonstrated the acceptability of the intervention among survivors, caregivers, and lung cancer care clinicians. The study also revealed the feasibility of conducting the proposed study methods in rural cancer care facilities. The project continues this program of research by conducting 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. Rural-residing lung cancer survivors will be recruited from ten oncology care facilities throughout Kentucky. The project's first aim compares the efficacy of the interventions with regard to lung cancer quality of life among survivors as measured by the FACT-L and other rigorous assessments of patient engagement, symptom burden, psychosocial well-being, and behavior change. The project's second aim evaluates the moderating impact of including caregivers as intervention partners on survivor quality of life outcomes. A third aim evaluates the cost-effectiveness of the KLCLCSC intervention in comparison to the enhanced usual care condition. Based on highly encouraging pilot data collected in collaboration with oncology care programs in Kentucky, this research holds credible potential to establish a new paradigm for addressing the challenges associated with lung cancer and for delivering quality survivorship care to rural-residing, economically distressed lung cancer survivors.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups

Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC)
Experimental group
Description:
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.
Treatment:
Behavioral: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program
Enhanced Usual Care (EUC)
Active Comparator group
Description:
The enhanced usual care condition involves usual care plus bibliotherapy and assessment.
Treatment:
Behavioral: Enhanced Usual Care

Trial contacts and locations

1

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Central trial contact

Jerod L Stapleton, PhD

Data sourced from clinicaltrials.gov

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