Precision Lung Cancer Survivorship Care Intervention

NCT05857995 | Recruiting DMC

• 2 other identifiers: 94571R01CA254734
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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; 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0) and 6 Months (T2)

Secondary Outcomes (12)

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

  Baseline (T0) and 6 Months (T2)

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

  Baseline (T0) and 6 Months (T2)

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

  Baseline (T0) and 6 Months (T2)

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

  Baseline (T0) and 6 Months (T2)

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

  Baseline (T0) and 6 Months (T2)

Study Arms (2)

Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC)

EXPERIMENTAL

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.

Behavioral: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program 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.

Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC)

Enhanced Usual Care BEHAVIORAL

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

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jerod L Stapleton, PhD: lead
• University of Louisville: collaborator
• G02 for Lung Cancer: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jamie L Studts, PhD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

• Jerod L Stapleton, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerod L Stapleton, PhD

CONTACT

8593237224; jerod.stapleton@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigators and outcomes assessors will be masked to the random assignment of participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Two-group randomized clinical trial

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 15, 2023
• Study Start: August 16, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)