Lung Cancer
Conditions
Keywords
Survivorship Care, Caregiving
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.
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.
Interventions
BEHAVIORALKY 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
Sponsors
University of Louisville
Lung Cancer Alliance
Bristol-Myers Squibb
Jamie Studts
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Intervention Feasibility A: Intervention accrual rate | 6 months post-baseline | Intervention Feasibility - study accrual rate (2A) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Countries
United States
Outcome results
None listed