Clinical trial NCT05857995: Precision Lung Cancer Survivorship Care Intervention
Official title: Precision Lung Cancer Survivorship Care Intervention: A Randomized Controlled Trial Serving Rural Survivors and Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Pulmonary Neoplasm
Neoplasms, Lung
Neoplasms, Pulmonary
Neoplasm, Pulmonary
Cancer, Lung
Cancers, Lung
Pulmonary Cancer
Cancer, Pulmonary
Cancers, Pulmonary
Pulmonary Cancers
Cancer of the Lung
Cancer of Lung
Pulmonary Neoplasms
Lung Cancers
Keywords: Survivorship
Quality of Life
Behavioral Oncology
Psychosocial Oncology
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Louisville
name: G02 for Lung Cancer
name: National Cancer Institute (NCI)
First posted: 2023-05-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline (T0) in Mean Lung Cancer Quality of Life at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
Secondary outcomes:
measure: Change from Baseline (T0) in Total Survivor Engagement at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Mean Lung Cancer Knowledge at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Mean Fatigue Symptoms at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Mean Sleep Disturbance at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Pulmonary Symptoms at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Mean Pain Interference at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Mean Emotional Social Support at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Mean Knowledge of Palliative Care at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Psychological Distress at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Mean Physical Activity at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Smoking Status at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
measure: Change from Baseline (T0) in Lung Cancer Stigma at 6 Months (T2)
timeFrame: Baseline (T0) and 6 Months (T2)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Colorado School of Medicine
name: Jamie L Studts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Jerod L Stapleton, PhD
role: PRINCIPAL_INVESTIGATOR
References: