Lung Cancer Clinical Trial
— KYLEADSIIOfficial 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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2027 |
Est. primary completion date | March 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | G02 for Lung Cancer, National Cancer Institute (NCI), University of Kentucky, University of Louisville |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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). | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) | |
Secondary | 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. | Baseline (T0) and 6 Months (T2) |
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