Clinical trial NCT02989974: Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program
Official title: Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Survivorship Care
Caregiving
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Louisville
name: Lung Cancer Alliance
name: Bristol-Myers Squibb
First posted: 2016-12-12
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey
timeFrame: 1 week post-intervention up to 1 month post-intervention
measure: Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey
timeFrame: 1 week post-intervention up to 1 month post-intervention
measure: Primary Survivor Acceptability C: Percentage of planned intervention modules completed by participating survivors based on SC Specialists intervention delivery tracking data
timeFrame: 1 week post-intervention up to 1 month post-intervention
Secondary outcomes:
measure: Secondary Intervention Feasibility A: Intervention accrual rate
timeFrame: 6 months post-baseline
measure: Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey
timeFrame: 6 months post-baseline
Other outcomes:
measure: Tertiary Study Feasibility A: Questionnaire 2 survey completion rate by survivors
timeFrame: 1 week post-intervention up to 1 month post-intervention
measure: Tertiary Study Feasibility B: Study drop-out rate among participating survivors
timeFrame: 1 week post-intervention up to 1 month post-intervention
measure: Tertiary Study Feasibility C: Rate of missing survivor/caregiver data
timeFrame: 1 week post-intervention up to 1 month post-intervention
measure: Additional Study Efficacy A1: Survivor quality of life
timeFrame: 1 week post-intervention up to 1 month post-intervention
measure: Additional Study Efficacy B1: Survivor lung cancer specific quality of life
timeFrame: 1 week post-intervention up to 1 month post-intervention
measure: Additional Study Efficacy A2: Caregiver quality of life
timeFrame: 1 week post-intervention up to 1 month post-intervention
measure: Additional Study Efficacy B2: Caregiver self-efficacy
timeFrame: 1 week post-intervention up to 1 month post-intervention
Locations:
city: Ashland
country: United States
facility: Kings Daughters Medical Center - Ashland
state: Kentucky
city: Danville
country: United States
facility: Commonwealth Cancer Center - Danville
state: Kentucky
city: Elizabethtown
country: United States
facility: Hardin Memorial Health - Elizabethtown
state: Kentucky
city: Hazard
country: United States
facility: Hazard ARH Regional Medical Center
state: Kentucky
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: UofL/Brown Cancer Center - Louisville
state: Kentucky
city: Madisonville
country: United States
facility: Baptist Health - Madisonville
state: Kentucky
city: Morehead
country: United States
facility: St. Claire Regional Medical Center - Morehead
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Health
state: Kentucky
Study officials:
affiliation: Professor, University of Kentucky College of Medicine
name: Jamie L Studts, PhD
role: PRINCIPAL_INVESTIGATOR
References: