Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: KY LEADS Survivorship Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who have been diagnosed with lung cancer (survivor) or Caregiver of a participating lung cancer survivor Ability to read and write in English Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KY LEADS Survivorship Care - Survivor<br>The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to individuals diagnosed with lung cancer (survivor). | Behavioral: KY LEADS Survivorship Care<br>* Survivor: Survivor questionnaire 1 at enrollment; KY LEADS Survivorship Care Program; survivor questionnaire 2 one week after program completion; survivor questionnaire 3 six months after enrollment. Caregiver: Caregiver questionnaire 1 at enrollment;KY LEADS Survivorship Care Program; caregiver questionnaire 2 one week after program completion; caregiver questionnaire 3 six months after enrollment<br>|
| Experimental: KY LEADS Survivorship Care - Caregiver<br>The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to caregivers of individuals diagnosed with lung cancer (caregiver) | Behavioral: KY LEADS Survivorship Care<br>* Survivor: Survivor questionnaire 1 at enrollment; KY LEADS Survivorship Care Program; survivor questionnaire 2 one week after program completion; survivor questionnaire 3 six months after enrollment. Caregiver: Caregiver questionnaire 1 at enrollment;KY LEADS Survivorship Care Program; caregiver questionnaire 2 one week after program completion; caregiver questionnaire 3 six months after enrollment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey | Participating survivor intervention acceptability (1A) | 1 week post-intervention up to 1 month post-intervention | 
| Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey | Participating survivor intervention satisfaction (1B) | 1 week post-intervention up to 1 month post-intervention | 
| Primary Survivor Acceptability C: Percentage of planned intervention modules completed by participating survivors based on SC Specialists intervention delivery tracking data | Participating survivor intervention uptake (1C) | 1 week post-intervention up to 1 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Intervention Feasibility A: Intervention accrual rate | Intervention Feasibility - study accrual rate (2A) | 6 months post-baseline | 
| Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey | Intervention Feasibility - SC Specialist ratings (2B) | 6 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Survivorship Care, Caregiving