Precision Lung Cancer Survivorship Care Intervention (KYLEADSII)

Precision Lung Cancer Survivorship Care Intervention: A Randomized Controlled Trial Serving Rural Survivors and Communities

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Neoplasms, Lung; Pulmonary Neoplasms; Neoplasms, Pulmonary; Pulmonary Cancer; Cancer of Lung; Cancer, Lung; Cancer of the Lung; Pulmonary Neoplasm; Lung Cancers; Neoplasm, Pulmonary; Cancers, Lung; Cancer, Pulmonary; Cancers, Pulmonary; Pulmonary Cancers
• Intervention / Treatment: Behavioral: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program; Behavioral: Enhanced Usual Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Courtney R Blair, MSM; Phone Number: (859) 218-6638; Email: courtney.blair@uky.edu
• Study Contact Backup: Name: Joan Kahl, MS; Phone Number: (859) 218-6222; Email: joan.kahl@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have been diagnosed with lung cancer
• Reside in a rural county as determined by a RUC code 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
Active Comparator: Enhanced Usual Care (EUC); The enhanced usual care condition involves usual care plus bibliotherapy and assessment.	Behavioral: Enhanced Usual Care; EUC involves a combination of the standard of care plus a bibliotherapy intervention and assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (T0) and 6 Months (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline (T0) in Mean Survivor Engagement at 6 Months (T2)	The Patient Activation Measure (PAM) is a standardized 13-item self-report measure of patient engagement.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Lung Cancer Knowledge at 6 Months (T2)	The Perceived Knowledge of Lung Cancer Scale is a 6-item intervention-specific measure of self-reported/perceived knowledge of lung cancer and survivorship developed for this research program.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Fatigue Symptoms at 6 Months (T2)	Fatigue Symptoms is a standardized 5-item self-report measure of fatigue within the Patient-Reported Outcomes Measurement Information System (PROMIS-Fatigue).	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Sleep Disturbance at 6 Months (T2)	Sleep Disturbance is a standardized 6-item self-report measure of sleep disruption within the Patient-Reported Outcomes Measurement Information System (PROMIS-Sleep).	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Respiratory Dysfunction at 6 Months (T2)	Respiratory Dysfunction (FACT-L Breathing Items) is a 3-item self-report measure of breathing problems drawn from the Functional Assessment of Cancer Therapy Lung Cancer Module.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Pain Interference at 6 Months (T2)	Pain Interference is a standardized 6-item self-report measure of pain interference within the Patient-Reported Outcomes Measurement Information System (PROMIS-Pain).	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Emotional Social Support at 6 Months (T2)	Emotional Social Support is a standardized 4-item self-report measure of emotional social support within the Patient-Reported Outcomes Measurement Information System (PROMIS-Emotional Support).	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Social Isolation at 6 Months (T2)	Social Isolation is a standardized 4-item self-report measure of social isolation within the Patient-Reported Outcomes Measurement Information System (PROMIS-Social Isolation).	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Social Constraints at 6 Months (T2)	The Social Constraint Scale is a standardized 15-item self-report instrument measuring social constraints in the past month targeted to the lung cancer experience.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Perceptions of Palliative Care at 6 Months (T2)	The Perceptions of Palliative Care (Perceptions) scale is a standardized 15-item self-report measure of knowledge and feeling about palliative care and hospice care.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Needs at the End of Life at 6 Months (T2)	Needs at the End of Life scale is a 5-item set of self-report questions regarding end of life needs, including spirituality, relationship, medical, and purpose.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Psychological Distress at 6 Months (T2)	The Distress Thermometer is an ultra-brief, single-item, standardized self-report measure of psychological distress developed and supported by the National Comprehensive Cancer Network (DT).	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Depressive Symptoms at 6 Months (T2)	Depressive Symptoms is a standardized 6-item self-report measure of depressive symptom burden within the Patient-Reported Outcomes Measurement Information System (PROMIS-Depression).	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Anxiety Symptoms at 6 Months (T2)	Anxiety Symptoms is a standardized 6-item self-report measure of anxiety symptom burden within the Patient-Reported Outcomes Measurement Information System (PROMIS-Anxiety).	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Lung Cancer Stigma at 6 Months (T2)	The Lung Cancer Stigma (Perceived Stigma Scale) is a 6-item self-report measure of perceived lung cancer stigma developed for this research program.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Physical Activity at 6 Months (T2)	The Physical Activity (BRFSS-Health Bxs-PA) measure includes 5 standardized self-report items drawn from the Behavioral Risk Factor Surveillance System to assess levels of physical activity.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Nutrition at 6 Months (T2)	The Nutrition (BRFSS-Health Bxs-Nutrition) measure includes 6 standardized self-report items drawn from the Behavioral Risk Factor Surveillance system to assess fruit and vegetable intake.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Smoking Status at 6 Months (T2)	The Smoking Status (BRFSS-Tobacco Use) measure is a single-item standardized self-report measure of 30-day smoking point prevalence.	Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Psychosocial Impact at 6 Months (T2)	Psychosocial Illness Impact - Positive is a standardized 8-item self-report instrument measuring perceived positive outcomes following illness within the Patient-Reported Outcomes Measurement Information System (PROMIS-Psychosocial Impact).	Baseline (T0) and 6 Months (T2)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI); University of Kentucky; University of Louisville; G02 for Lung Cancer
• Investigators: Principal Investigator: Jamie L Studts, PhD, University of Colorado School of Medicine; Principal Investigator: Jessica L Burris, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): March 31, 2026
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Survivorship; Psychosocial Oncology; Behavioral Oncology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 21-XXXX.cc; R01CA254734 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No