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Precision Lung Cancer Survivorship Care Intervention: A Randomized Controlled Trial Serving Rural Survivors and Communities

NCT ID: NCT05857995Sponsor: Jerod L Stapleton, PhDLast updated: 2026-02-23

Summary

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.

Detailed 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.

Arms & interventions

  • BehavioralKentucky LEADS Collaborative Lung Cancer Survivorship Care Program

    KLCLCSC is a survivor or survivor plus caregiver-focused psychosocial and behavioral intervention designed to engage lung cancer survivors and improve lung cancer outcomes.

  • BehavioralEnhanced Usual Care

    EUC involves a combination of the standard of care plus a bibliotherapy intervention and assessment.

Outcome measures

Primary

  • 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.

    Time frame: Baseline (T0) and 6 Months (T2)

Secondary

  • Change from Baseline (T0) in Total Survivor Engagement at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Mean Lung Cancer Knowledge at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Mean Fatigue Symptoms at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Mean Sleep Disturbance at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Pulmonary Symptoms at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Mean Pain Interference at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Mean Emotional Social Support at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Mean Knowledge of Palliative Care at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Psychological Distress at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Mean Physical Activity at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Smoking Status at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

  • Change from Baseline (T0) in Lung Cancer Stigma at 6 Months (T2)

    Time frame: Baseline (T0) and 6 Months (T2)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Markey Cancer Center

Lexington, Kentucky, 40536

Recruiting
Jerod L Stapleton, PhD · Contact
Precision Lung Cancer Survivorship Care Intervention | Cancerify