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

Jamie Studts

Status: Completed

Conditions: Lung Cancer

Treatments: Behavioral: KY LEADS Survivorship Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02989974

17-BS-01

16-0813 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

KY LEADS Survivorship Care - Survivor

Experimental group

Description:

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

Treatment:

Behavioral: KY LEADS Survivorship Care

KY LEADS Survivorship Care - Caregiver

Experimental group

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)

Treatment:

Behavioral: KY LEADS Survivorship Care