Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

Lung Cancer Clinical Trial

— KYLEADS-SC  

Official title:

Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989974
• Other study ID #: 17-BS-01
• Secondary ID: 16-0813
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: April 24, 2019

Study information

• Verified date: October 2020
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: April 24, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Kings Daughters Medical Center - Ashland	Ashland	Kentucky
United States	Commonwealth Cancer Center - Danville	Danville	Kentucky
United States	Hardin Memorial Health - Elizabethtown	Elizabethtown	Kentucky
United States	Hazard ARH Regional Medical Center	Hazard	Kentucky
United States	Markey Cancer Center	Lexington	Kentucky
United States	UofL/Brown Cancer Center - Louisville	Louisville	Kentucky
United States	Baptist Health - Madisonville	Madisonville	Kentucky
United States	St. Claire Regional Medical Center - Morehead	Morehead	Kentucky
United States	Owensboro Health	Owensboro	Kentucky

Sponsors (4)

Lead Sponsor	Collaborator
Jamie Studts	Bristol-Myers Squibb Foundation, Lung Cancer Alliance, University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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	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	Secondary Intervention Feasibility A: Intervention accrual rate	Intervention Feasibility - study accrual rate (2A)	6 months post-baseline
Secondary	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