Cancer Metastatic to Lung
Conditions
Brief summary
Patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. Most metavivors will ultimately die of cancer and must navigate the duality of living while dying. Unsurprisingly, metavivors endorse high psychological distress (e.g., anxiety, depression, illness non-acceptance), high symptom burden (e.g., fatigue, dyspnea, pain), and poor quality of life. Psychosocial interventions can improve outcomes, but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease. Dialectical Behavioral Therapy (DBT) Skills Training is an evidence-based treatment that teaches patients transdiagnostic, easy-to-use skills to both accept things as they are (mindfulness, distress tolerance) and change things within their control (emotion regulation, interpersonal effectiveness) to better navigate life challenges. However, DBT Skills Training has rarely been applied in patients with chronic illness. The investigators adapted DBT Skills Training (e.g., intervention dose, delivery, content) for patients living with metastatic lung cancer to create LiveWell, an 8-session Skills Training protocol delivered one-on-one via videoconference. Building on preliminary data and aligned with the ORBIT model for behavioral intervention development, the first phase of this study (K99, Aim 1, 1 year) aims to iteratively refine LiveWell using 1) qualitative exit interview data from a proof-of-concept study, 2) an advisory board of interested parties, 3) the Dynamic Sustainability Framework from implementation science, and 4) user testing (n= up to 10). The K99 phase will produce a standardized protocol and procedures for the second, independent phase of the study (R00) which will be registered separately. If successful, LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.
Interventions
BEHAVIORALLiveWell: Adapted Dialectical Behavioral Therapy Skills Training
An adapted dialectical behavioral therapy skills training intervention
Sponsors
Duke University
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single arm for user testing
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer * Undergoing lung cancer treatment with non-curative intent * Endorse \>=3 out of 10 on the NCCN distress thermometer over the past week * At least 18 years of age * Able to understand, speak, and read English, and 5) be able to provide informed consent
Exclusion criteria
* Reported or suspected cognitive impairment * Presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist * Expected survival \<6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires | Up to 8 weeks |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTamara Somers
Professor in Psychiatry and Behavioral Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
None listed