Precision Lung Cancer Survivorship Care Intervention

NCT ID: NCT05857995

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2027-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC)

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.

Group Type: EXPERIMENTAL

Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program

Intervention Type: BEHAVIORAL

KLCLCSC 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 (EUC)

The enhanced usual care condition involves usual care plus bibliotherapy and assessment.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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

Interventions

Kentucky 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.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: collaborator

G02 for Lung Cancer

UNKNOWN

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jerod L Stapleton, PhD

OTHER

Sponsor Role: lead

Responsible Party

Jerod L Stapleton, PhD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jamie L Studts, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Jerod L Stapleton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Markey Cancer Center

Lexington, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jerod L Stapleton, PhD

Role: CONTACT

jerod.stapleton@uky.edu

8593237224

Facility Contacts

Jerod L Stapleton, PhD

Role: primary

jerodstapleton@uky.edu

Other Identifiers

R01CA254734

Identifier Type: NIH

Identifier Source: secondary_id

View Link

94571

Identifier Type: -

Identifier Source: org_study_id