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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KY LEADS Survivorship Care
Sponsored by
Jamie Studts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Survivorship Care, Caregiving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kings Daughters Medical Center - Ashland
  • Commonwealth Cancer Center - Danville
  • Hardin Memorial Health - Elizabethtown
  • Hazard ARH Regional Medical Center
  • Markey Cancer Center
  • UofL/Brown Cancer Center - Louisville
  • Baptist Health - Madisonville
  • St. Claire Regional Medical Center - Morehead
  • Owensboro Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

KY LEADS Survivorship Care - Survivor

KY LEADS Survivorship Care - Caregiver

Arm Description

The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to individuals diagnosed with lung cancer (survivor).

The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to caregivers of individuals diagnosed with lung cancer (caregiver)

Outcomes

Primary Outcome Measures

Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey
Participating survivor intervention acceptability (1A)
Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey
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
Participating survivor intervention uptake (1C)

Secondary Outcome Measures

Secondary Intervention Feasibility A: Intervention accrual rate
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
Intervention Feasibility - SC Specialist ratings (2B)

Full Information

First Posted
December 2, 2016
Last Updated
October 27, 2020
Sponsor
Jamie Studts
Collaborators
University of Louisville, Lung Cancer Alliance, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02989974
Brief Title
Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program
Acronym
KYLEADS-SC
Official Title
Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
April 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jamie Studts
Collaborators
University of Louisville, Lung Cancer Alliance, Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Survivorship Care, Caregiving

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KY LEADS Survivorship Care - Survivor
Arm Type
Experimental
Arm Description
The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to individuals diagnosed with lung cancer (survivor).
Arm Title
KY LEADS Survivorship Care - Caregiver
Arm Type
Experimental
Arm Description
The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to caregivers of individuals diagnosed with lung cancer (caregiver)
Intervention Type
Behavioral
Intervention Name(s)
KY LEADS Survivorship Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey
Description
Participating survivor intervention acceptability (1A)
Time Frame
1 week post-intervention up to 1 month post-intervention
Title
Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey
Description
Participating survivor intervention satisfaction (1B)
Time Frame
1 week post-intervention up to 1 month post-intervention
Title
Primary Survivor Acceptability C: Percentage of planned intervention modules completed by participating survivors based on SC Specialists intervention delivery tracking data
Description
Participating survivor intervention uptake (1C)
Time Frame
1 week post-intervention up to 1 month post-intervention
Secondary Outcome Measure Information:
Title
Secondary Intervention Feasibility A: Intervention accrual rate
Description
Intervention Feasibility - study accrual rate (2A)
Time Frame
6 months post-baseline
Title
Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey
Description
Intervention Feasibility - SC Specialist ratings (2B)
Time Frame
6 months post-baseline
Other Pre-specified Outcome Measures:
Title
Tertiary Study Feasibility A: Questionnaire 2 survey completion rate by survivors
Description
Study Feasibility - Survivor survey completion rate (3A)
Time Frame
1 week post-intervention up to 1 month post-intervention
Title
Tertiary Study Feasibility B: Study drop-out rate among participating survivors
Description
Study Feasibility - Survivor drop-out rate (3B)
Time Frame
1 week post-intervention up to 1 month post-intervention
Title
Tertiary Study Feasibility C: Rate of missing survivor/caregiver data
Description
Study Feasibility - Rate of missing survivor/caregiver data (3C)
Time Frame
1 week post-intervention up to 1 month post-intervention
Title
Additional Study Efficacy A1: Survivor quality of life
Description
Study Efficacy - Impact on survivor quality of life (FACT-G) (4A1)
Time Frame
1 week post-intervention up to 1 month post-intervention
Title
Additional Study Efficacy B1: Survivor lung cancer specific quality of life
Description
Study Efficacy - Impact on survivor lung cancer specific quality of life (FACT-L) (4B1)
Time Frame
1 week post-intervention up to 1 month post-intervention
Title
Additional Study Efficacy A2: Caregiver quality of life
Description
tudy Efficacy - Impact on caregiver quality of life (C-QoL) (4A2)
Time Frame
1 week post-intervention up to 1 month post-intervention
Title
Additional Study Efficacy B2: Caregiver self-efficacy
Description
Study Efficacy - Impact on caregiver self-efficacy (CSES) (4B2)
Time Frame
1 week post-intervention up to 1 month post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie L Studts, PhD
Organizational Affiliation
Professor, University of Kentucky College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings Daughters Medical Center - Ashland
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Commonwealth Cancer Center - Danville
City
Danville
State/Province
Kentucky
ZIP/Postal Code
40422
Country
United States
Facility Name
Hardin Memorial Health - Elizabethtown
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
Hazard ARH Regional Medical Center
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
UofL/Brown Cancer Center - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Baptist Health - Madisonville
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
St. Claire Regional Medical Center - Morehead
City
Morehead
State/Province
Kentucky
ZIP/Postal Code
40351
Country
United States
Facility Name
Owensboro Health
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

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