Lung CancerKYLEADSIINCT05857995
Precision Lung Cancer Survivorship Care Intervention
A study testing Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program in people with Lung Cancer and Pulmonary Neoplasm, run by Jerod L Stapleton, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pulmonary Neoplasm, Neoplasms, Lung
- What is being tested?
- Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Markey Cancer Center
Lexington, Kentucky, 40536
Jerod L Stapleton, PhD, jerodstapleton@uky.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program, Enhanced Usual Care
- Keywords
- Survivorship, Quality of Life, Behavioral Oncology, Psychosocial Oncology
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kentucky LEADS Collaborative Lung Cancer Survivorship Care ProgramBehavioural
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 CareBehavioural
EUC involves a combination of the standard of care plus a bibliotherapy intervention and assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) and 6 Months (T2)
Secondary outcomes (12)
Change from Baseline (T0) in Total Survivor Engagement at 6 Months (T2)
The Patient Activation Measure (PAM) is a standardized 13-item self-report measure of patient engagement with a theoretical range of 0 to 100 with higher scores indicating greater engagement.
Measured: 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. Scores range from 0 to 24 with higher scores indicating greater knowledge.
Measured: 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). Scores range from 0 to 20 with higher scores indicating better quality of life and lesser fatigue symptoms.
Measured: 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). Scores range from 0 to 20 with higher scores indicating better quality of life and lesser seep disturbance.
Measured: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Pulmonary Symptoms at 6 Months (T2)
Respiratory Dysfunction (FACT-L Pulmonary Symptom Index) is a 4-item self-report measure of breathing problems drawn from the Functional Assessment of Cancer Therapy Lung Cancer Module. Scores range from 0 to 16 with higher scores indicating better quality of life and lower pulmonary symptoms.
Measured: 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). Scores range from 0 to 24 with higher scores indicating better quality of life and lesser pain interference.
Measured: 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). Scores range from 0 to 16 with higher scores indicating better quality of life and greater emotional social support.
Measured: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Knowledge of Palliative Care at 6 Months (T2)
The Knowledge of Palliative Care (Perceptions) scale is a standardized 4-item self-report measure of knowledge about palliative care. Scores range from 4 to 16 with higher scores indicating greater self-rated knowledge of palliative care.
Measured: 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) with higher scores indicating greater distress (Range = 0 to 10).
Measured: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Physical Activity at 6 Months (T2)
The Godin Leisure-Time Exercise Questionnaire includes 3 standardized self-report items assessing levels of strenuous, moderate, and mild/light physical activity. Scores are based on weekly activities with zero being the lowest score and higher scores indicating more frequent and strenuous physical activity.
Measured: 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. Scores range from 0 to 1 with 1 indicating current smoking.
Measured: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Lung Cancer Stigma at 6 Months (T2)
The Lung Cancer Stigma Inventory - Short Form includes 12 self-report items measuring lung cancer stigma. Scores range from 12 to 60 with higher scores indicating greater lung cancer stigma.
Measured: Baseline (T0) and 6 Months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start16 Aug 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group randomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerod L Stapleton, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Louisville, G02 for Lung Cancer, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Jerod L Stapleton, PhD, University of Kentucky
- Investigators
- Jamie L Studts, PhD, Principal investigator, University of Colorado School of MedicineJerod L Stapleton, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857995
- Sponsor's protocol ID
- 94571
- Other IDs
- R01CA254734
- Acronym
- KYLEADSII
- Status last verified
- Feb 2026
- First submitted
- 4 May 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Lung Cancer Survivorship Care Intervention: A Randomized Controlled Trial Serving Rural Survivors and Communities
- ClinicalTrials.gov ID
- NCT05857995
- Acronym / sponsor ID
- KYLEADSII / 94571
- Conditions
- Lung Cancer, Pulmonary Neoplasm, Neoplasms, Lung, Neoplasms, Pulmonary, Neoplasm, Pulmonary, Cancer, Lung
- Keywords
- Survivorship, Quality of Life, Behavioral Oncology, Psychosocial Oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jerod L Stapleton, PhDUniversity, hospital or other
- Collaborators
- University of Louisville, G02 for Lung Cancer, National Cancer Institute (NCI)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) | Experimental | Behavioral: Kentucky LEADS Collaborative Lung Cancer Survivorship Care ProgramThe 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. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual CareThe enhanced usual care condition involves usual care plus bibliotherapy and assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kentucky LEADS Collaborative Lung Cancer Survivorship Care ProgramKLCLCSC is a survivor or survivor plus caregiver-focused psychosocial and behavioral intervention designed to engage lung cancer survivors and improve lung cancer outcomes. | Behavioural | Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) |
| Enhanced Usual CareEUC involves a combination of the standard of care plus a bibliotherapy intervention and assessment. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
Change from Baseline (T0) in Mean Lung Cancer Quality of Life at 6 Months (T2)
Time frame: Baseline (T0) and 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.
12 secondary outcomes
Change from Baseline (T0) in Total Survivor Engagement at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Lung Cancer Knowledge at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Fatigue Symptoms at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Sleep Disturbance at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Pulmonary Symptoms at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Pain Interference at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Emotional Social Support at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Knowledge of Palliative Care at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Psychological Distress at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Mean Physical Activity at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Smoking Status at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Change from Baseline (T0) in Lung Cancer Stigma at 6 Months (T2)
Time frame: Baseline (T0) and 6 Months (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie L Studts, PhD principal investigator
University of Colorado School of Medicine
Jerod L Stapleton, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program in people with Lung Cancer and Pulmonary Neoplasm, run by Jerod L Stapleton, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerod L Stapleton, PhD (8593237224, jerod.stapleton@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.