Precision Lung Cancer Survivorship Care Intervention

Trial Title: Precision Lung Cancer Survivorship Care Intervention

NCT ID: NCT05857995

Condition: 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

Conditions: Official terms:
Lung Neoplasms
Neoplasms

Conditions: Keywords:
Survivorship
Quality of Life
Behavioral Oncology
Psychosocial Oncology

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Two-group randomized clinical trial

Primary purpose: Supportive Care

Masking: Double (Investigator, Outcomes Assessor)

Masking description: The principal investigators and outcomes assessors will be masked to the random assignment of participants.

Intervention:

Intervention type: Behavioral
Intervention name: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program
Description: KLCLCSC is a survivor or survivor plus caregiver-focused psychosocial and behavioral intervention designed to engage lung cancer survivors and improve lung cancer outcomes.
Arm group label: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC)

Intervention type: Behavioral
Intervention name: Enhanced Usual Care
Description: EUC involves a combination of the standard of care plus a bibliotherapy intervention and assessment.
Arm group label: Enhanced Usual Care (EUC)

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Markey Cancer Center

Address:
City: Lexington
Zip: 40536
Country: United States

Status: Recruiting

Contact:
Last name: Jerod L Stapleton, PhD
Email: jerodstapleton@uky.edu

Start date: August 16, 2024

Completion date: June 30, 2027

Lead sponsor:
Agency: Jerod L Stapleton, PhD
Agency class: Other

Collaborator:
Agency: University of Louisville
Agency class: Other

Collaborator:
Agency: G02 for Lung Cancer
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Kentucky

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05857995