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| ID | Type | Description | Link |
|---|---|---|---|
| 16-0813 | Other Identifier | Univ of KY IRB |
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| Name | Class |
|---|---|
| University of Louisville | OTHER |
| Lung Cancer Alliance | UNKNOWN |
| Bristol-Myers Squibb | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KY LEADS Survivorship Care - Survivor | Experimental | The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to individuals diagnosed with lung cancer (survivor). |
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| KY LEADS Survivorship Care - Caregiver | Experimental | The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to caregivers of individuals diagnosed with lung cancer (caregiver) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KY LEADS Survivorship Care | Behavioral | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tertiary Study Feasibility A: Questionnaire 2 survey completion rate by survivors | Study Feasibility - Survivor survey completion rate (3A) | 1 week post-intervention up to 1 month post-intervention |
| Tertiary Study Feasibility B: Study drop-out rate among participating survivors |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie L Studts, PhD | Professor, University of Kentucky College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kings Daughters Medical Center - Ashland | Ashland | Kentucky | 41101 | United States | ||
| Commonwealth Cancer Center - Danville |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Intervention Feasibility - SC Specialist ratings (2B) |
| 6 months post-baseline |
Study Feasibility - Survivor drop-out rate (3B) |
| 1 week post-intervention up to 1 month post-intervention |
| Tertiary Study Feasibility C: Rate of missing survivor/caregiver data | Study Feasibility - Rate of missing survivor/caregiver data (3C) | 1 week post-intervention up to 1 month post-intervention |
| Additional Study Efficacy A1: Survivor quality of life | Study Efficacy - Impact on survivor quality of life (FACT-G) (4A1) | 1 week post-intervention up to 1 month post-intervention |
| Additional Study Efficacy B1: Survivor lung cancer specific quality of life | Study Efficacy - Impact on survivor lung cancer specific quality of life (FACT-L) (4B1) | 1 week post-intervention up to 1 month post-intervention |
| Additional Study Efficacy A2: Caregiver quality of life | tudy Efficacy - Impact on caregiver quality of life (C-QoL) (4A2) | 1 week post-intervention up to 1 month post-intervention |
| Additional Study Efficacy B2: Caregiver self-efficacy | Study Efficacy - Impact on caregiver self-efficacy (CSES) (4B2) | 1 week post-intervention up to 1 month post-intervention |
| Danville |
| Kentucky |
| 40422 |
| United States |
| Hardin Memorial Health - Elizabethtown | Elizabethtown | Kentucky | 42701 | United States |
| Hazard ARH Regional Medical Center | Hazard | Kentucky | 41701 | United States |
| Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| UofL/Brown Cancer Center - Louisville | Louisville | Kentucky | 40202 | United States |
| Baptist Health - Madisonville | Madisonville | Kentucky | 42431 | United States |
| St. Claire Regional Medical Center - Morehead | Morehead | Kentucky | 40351 | United States |
| Owensboro Health | Owensboro | Kentucky | 42303 | United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |