Recruiting

Lung Cancer Care

Sponsor:

Jerod L Stapleton, PhD

Code:

NCT05857995

Conditions

Lung Cancer

Pulmonary Neoplasm

Neoplasms, Lung

Neoplasms, Pulmonary

Neoplasm, Pulmonary

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program

Enhanced Usual Care

Study Details

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.

Conditions

Lung Cancer

Pulmonary Neoplasm

Neoplasms, Lung

Neoplasms, Pulmonary

Neoplasm, Pulmonary

Study ID

NCT05857995

Start date

Aug 16, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Enhanced Usual Care (EUC)

The enhanced usual care condition involves usual care plus bibliotherapy 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.

Enhanced Usual Care

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

Primary outcome measure

  • Change from Baseline (T0) in Mean Lung Cancer Quality of Life at 6 Months (T2) [ Time Frame: Baseline (T0) and 6 Months (T2) ]

Central Contacts and Locations

Central contacts

Jerod L Stapleton, PhD

8593237224jerod.stapleton@uky.edu

Locations

Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Jerod L Stapleton, PhD

jerodstapleton@uky.edu

More Information

Sponsor

Jerod L Stapleton, PhD

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Survivorship
  • Quality of Life
  • Behavioral Oncology
  • Psychosocial Oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jerod L Stapleton, PhD on 2026-02-23.