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Completed

NCT Number: NCT02989974

Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kings Daughters Medical Center - Ashland, Ashland, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Primary Survivor Acceptability A: Percentage of participating survivors that would recommend the program to other survivors on POST survey

    Time frame: 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

    Time frame: 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

    Time frame: 1 week post-intervention up to 1 month post-intervention

    Participating survivor intervention uptake (1C)

Secondary outcomes

  1. Secondary Intervention Feasibility A: Intervention accrual rate

    Time frame: 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

    Time frame: 6 months post-baseline

    Intervention Feasibility - SC Specialist ratings (2B)

Other outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 week post-intervention up to 1 month post-intervention

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

Sponsors and collaborators

Lead sponsor

Jamie Studts

Other

Collaborators

  • Bristol-Myers Squibb
  • Lung Cancer Alliance
  • University of Louisville

Registry information

Official study title

Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers

Acronym: KYLEADS-SC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2016
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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