Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

NCT02989974 | Completed DMC

• 2 other identifiers: 17-BS-0116-0813
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 9

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.

Conditions

Lung Cancer

Keywords

Survivorship Care; Caregiving

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Secondary Intervention Feasibility A: Intervention accrual rate

  6 months post-baseline

• Secondary Intervention Feasibility B: Survivorship Care (SC) Specialist ratings of intervention feasibility based on SC Specialist ratings on POST survey

  6 months post-baseline

Other Outcomes (7)

• Tertiary Study Feasibility A: Questionnaire 2 survey completion rate by survivors

  1 week post-intervention up to 1 month post-intervention

• Tertiary Study Feasibility B: Study drop-out rate among participating survivors

  1 week post-intervention up to 1 month post-intervention

• Tertiary Study Feasibility C: Rate of missing survivor/caregiver data

  1 week post-intervention up to 1 month post-intervention

Study Arms (2)

KY LEADS Survivorship Care - Survivor

EXPERIMENTAL

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

KY LEADS Survivorship Care - Caregiver

EXPERIMENTAL

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

Interventions

KY LEADS Survivorship Care BEHAVIORAL

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

KY LEADS Survivorship Care - Caregiver; KY LEADS Survivorship Care - Survivor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who have been diagnosed with lung cancer (survivor) or
• Caregiver of a participating lung cancer survivor
• Ability to read and write in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Jamie Studts: lead
• University of Louisville: collaborator
• Lung Cancer Alliance: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (9)

Kings Daughters Medical Center - Ashland

Ashland, Kentucky, 41101, United States

Location

Commonwealth Cancer Center - Danville

Danville, Kentucky, 40422, United States

Location

Hardin Memorial Health - Elizabethtown

Elizabethtown, Kentucky, 42701, United States

Location

Hazard ARH Regional Medical Center

Hazard, Kentucky, 41701, United States

Location

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

UofL/Brown Cancer Center - Louisville

Louisville, Kentucky, 40202, United States

Location

Baptist Health - Madisonville

Madisonville, Kentucky, 42431, United States

Location

St. Claire Regional Medical Center - Morehead

Morehead, Kentucky, 40351, United States

Location

Owensboro Health

Owensboro, Kentucky, 42303, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jamie L Studts, PhD

  Professor, University of Kentucky College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 12, 2016
• Study Start: February 10, 2017
• Primary Completion: April 24, 2019
• Study Completion: April 24, 2019
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)