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Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

NCT ID: NCT02989974

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2019-04-24

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

KY LEADS Survivorship Care

Intervention Type 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

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

Group Type EXPERIMENTAL

KY LEADS Survivorship Care

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role collaborator

Lung Cancer Alliance

UNKNOWN

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Jamie Studts

OTHER

Sponsor Role lead

Responsible Party

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Jamie Studts

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jamie L Studts, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, University of Kentucky College of Medicine

Locations

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Kings Daughters Medical Center - Ashland

Ashland, Kentucky, United States

Site Status

Commonwealth Cancer Center - Danville

Danville, Kentucky, United States

Site Status

Hardin Memorial Health - Elizabethtown

Elizabethtown, Kentucky, United States

Site Status

Hazard ARH Regional Medical Center

Hazard, Kentucky, United States

Site Status

Markey Cancer Center

Lexington, Kentucky, United States

Site Status

UofL/Brown Cancer Center - Louisville

Louisville, Kentucky, United States

Site Status

Baptist Health - Madisonville

Madisonville, Kentucky, United States

Site Status

St. Claire Regional Medical Center - Morehead

Morehead, Kentucky, United States

Site Status

Owensboro Health

Owensboro, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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16-0813

Identifier Type: OTHER

Identifier Source: secondary_id

17-BS-01

Identifier Type: -

Identifier Source: org_study_id