Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program (KYLEADS-SC)

Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: KY LEADS Survivorship Care

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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Kings Daughters Medical Center - Ashland
    • Danville, Kentucky, United States, 40422
      • Commonwealth Cancer Center - Danville
    • Elizabethtown, Kentucky, United States, 42701
      • Hardin Memorial Health - Elizabethtown
    • Hazard, Kentucky, United States, 41701
      • Hazard ARH Regional Medical Center
    • Lexington, Kentucky, United States, 40536
      • Markey Cancer Center
    • Louisville, Kentucky, United States, 40202
      • UofL/Brown Cancer Center - Louisville
    • Madisonville, Kentucky, United States, 42431
      • Baptist Health - Madisonville
    • Morehead, Kentucky, United States, 40351
      • St. Claire Regional Medical Center - Morehead
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KY LEADS Survivorship Care - Survivor; 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; 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
Experimental: KY LEADS Survivorship Care - Caregiver; 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jamie Studts
• Collaborators: University of Louisville; Bristol-Myers Squibb Foundation; Lung Cancer Alliance
• Investigators: Principal Investigator: Jamie L Studts, PhD, Professor, University of Kentucky College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): April 24, 2019

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Caregiving; Survivorship Care
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 17-BS-01; 16-0813 (Other Identifier: Univ of KY IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No