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

• Sponsor: Jamie Studts (Other)
• Overall Status: Completed
• CT.gov ID: NCT02989974
• Collaborator: University of Louisville (Other), Lung Cancer Alliance (Other), Bristol-Myers Squibb Foundation (Other)
• Enrollment: 214
• Locations: 9
• Arms: 2
• Actual Duration (Months): 26.4
• Patients Per Site: 23.8
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Behavioral: KY LEADS Survivorship Care	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 214 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers
• Actual Study Start Date: Feb 10, 2017
• Actual Primary Completion Date: Apr 24, 2019
• Actual Study Completion Date: Apr 24, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey [1 week post-intervention up to 1 month post-intervention]

   Participating survivor intervention acceptability (1A)

2. Primary Survivor Acceptability B: Mean rating of participating survivor intervention satisfaction on POST survey [1 week post-intervention up to 1 month post-intervention]

   Participating survivor intervention satisfaction (1B)

3. Primary Survivor Acceptability C: Percentage of planned intervention modules completed by participating survivors based on SC Specialists intervention delivery tracking data [1 week post-intervention up to 1 month post-intervention]

   Participating survivor intervention uptake (1C)

Secondary Outcome Measures

1. Secondary Intervention Feasibility A: Intervention accrual rate [6 months post-baseline]

   Intervention Feasibility - study accrual rate (2A)

2. Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey [6 months post-baseline]

   Intervention Feasibility - SC Specialist ratings (2B)

Other Outcome Measures

1. Tertiary Study Feasibility A: Questionnaire 2 survey completion rate by survivors [1 week post-intervention up to 1 month post-intervention]

   Study Feasibility - Survivor survey completion rate (3A)

2. Tertiary Study Feasibility B: Study drop-out rate among participating survivors [1 week post-intervention up to 1 month post-intervention]

   Study Feasibility - Survivor drop-out rate (3B)

3. Tertiary Study Feasibility C: Rate of missing survivor/caregiver data [1 week post-intervention up to 1 month post-intervention]

   Study Feasibility - Rate of missing survivor/caregiver data (3C)

4. Additional Study Efficacy A1: Survivor quality of life [1 week post-intervention up to 1 month post-intervention]

   Study Efficacy - Impact on survivor quality of life (FACT-G) (4A1)

5. Additional Study Efficacy B1: Survivor lung cancer specific quality of life [1 week post-intervention up to 1 month post-intervention]

   Study Efficacy - Impact on survivor lung cancer specific quality of life (FACT-L) (4B1)

6. Additional Study Efficacy A2: Caregiver quality of life [1 week post-intervention up to 1 month post-intervention]

   tudy Efficacy - Impact on caregiver quality of life (C-QoL) (4A2)

7. Additional Study Efficacy B2: Caregiver self-efficacy [1 week post-intervention up to 1 month post-intervention]

   Study Efficacy - Impact on caregiver self-efficacy (CSES) (4B2)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kings Daughters Medical Center - Ashland	Ashland	Kentucky	United States	41101
2	Commonwealth Cancer Center - Danville	Danville	Kentucky	United States	40422
3	Hardin Memorial Health - Elizabethtown	Elizabethtown	Kentucky	United States	42701
4	Hazard ARH Regional Medical Center	Hazard	Kentucky	United States	41701
5	Markey Cancer Center	Lexington	Kentucky	United States	40536
6	UofL/Brown Cancer Center - Louisville	Louisville	Kentucky	United States	40202
7	Baptist Health - Madisonville	Madisonville	Kentucky	United States	42431
8	St. Claire Regional Medical Center - Morehead	Morehead	Kentucky	United States	40351
9	Owensboro Health	Owensboro	Kentucky	United States	42303

Sponsors and Collaborators

• Jamie Studts
• University of Louisville
• Lung Cancer Alliance
• Bristol-Myers Squibb Foundation

Investigators

• Principal Investigator: Jamie L Studts, PhD, Professor, University of Kentucky College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jamie Studts, Principal Investigator, University of Kentucky
• ClinicalTrials.gov Identifier: NCT02989974
• Other Study ID Numbers: 17-BS-01; 16-0813
• First Posted: Dec 12, 2016
• Last Update Posted: Oct 29, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jamie Studts, Principal Investigator, University of Kentucky: Survivorship Care; Caregiving
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Oct 29, 2020