Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program
- Conditions
- Lung Cancer
- Registration Number
- NCT02989974
- Lead Sponsor
- Jamie Studts
- Brief Summary
The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop, administer and evaluate the impact of a comprehensive psychosocial survivorship care program for individuals diagnosed with lung cancer and their caregivers to improve lung cancer survivorship and delivery of high-quality lung cancer care. The investigators hypothesize that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved quality of life, better symptom control, increased tobacco treatment, and reduced distress among lung cancer survivors and their caregivers.
- Detailed Description
The study design is a single-arm clinical trial, or a prospective cohort design, where a longitudinal series of data will be collected from participants. Participants will be consented and asked to complete a baseline questionnaire (PRE) which includes topics measuring quality of life, distress, symptom management, social support, healthy behaviors, demographics and health history. Two similar questionnaires will be administered after exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form requests permission from survivors to collect clinical data from medical records and the Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will enroll 300 participants, with an estimate of approximately 30 participants enrolled at each site. However, if a participating site enrolls 30 participants and the overall study accrual has not yet been met, the study PI may allow that respective participating site to continue to enroll participants. Study accrual is competitive across participating sites until the overall study accrual has been met.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- Individuals who have been diagnosed with lung cancer (survivor) or
- Caregiver of a participating lung cancer survivor
- Ability to read and write in English
- Individuals with significant psychiatric disturbance that requires a higher level of care
- Individuals with substance abuse/dependence problem that require a higher level of care
- Incarcerate individuals or individuals detained within the legal system
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey 1 week post-intervention up to 1 month post-intervention Participating survivor intervention acceptability (1A)
Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey 1 week post-intervention up to 1 month post-intervention Participating survivor intervention satisfaction (1B)
Primary Survivor Acceptability C: Percentage of planned intervention modules completed by participating survivors based on SC Specialists intervention delivery tracking data 1 week post-intervention up to 1 month post-intervention Participating survivor intervention uptake (1C)
- Secondary Outcome Measures
Name Time Method Secondary Intervention Feasibility A: Intervention accrual rate 6 months post-baseline Intervention Feasibility - study accrual rate (2A)
Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey 6 months post-baseline Intervention Feasibility - SC Specialist ratings (2B)
Trial Locations
- Locations (9)
Kings Daughters Medical Center - Ashland
🇺🇸Ashland, Kentucky, United States
Commonwealth Cancer Center - Danville
🇺🇸Danville, Kentucky, United States
Hardin Memorial Health - Elizabethtown
🇺🇸Elizabethtown, Kentucky, United States
Hazard ARH Regional Medical Center
🇺🇸Hazard, Kentucky, United States
Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
UofL/Brown Cancer Center - Louisville
🇺🇸Louisville, Kentucky, United States
Baptist Health - Madisonville
🇺🇸Madisonville, Kentucky, United States
St. Claire Regional Medical Center - Morehead
🇺🇸Morehead, Kentucky, United States
Owensboro Health
🇺🇸Owensboro, Kentucky, United States
Kings Daughters Medical Center - Ashland🇺🇸Ashland, Kentucky, United States