Trial Outcomes & Findings for DBT for Metastatic Lung Cancer (NCT NCT04973436)
NCT ID: NCT04973436
Last Updated: 2025-04-27
Results Overview
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Post-intervention (approximately 8 weeks)
Results posted on
2025-04-27
Participant Flow
One participant was lost to contact prior to baseline assessment.
Participant milestones
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Overall Study
STARTED
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30
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Overall Study
Completed Protocol
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27
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Overall Study
Post-Intervention Assessment
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26
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Overall Study
1-Month Follow-up Assessment
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24
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Overall Study
COMPLETED
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24
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Overall Study
Lost to Follow-up
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3
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Death
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2
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Baseline Characteristics
DBT for Metastatic Lung Cancer
Baseline characteristics by cohort
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Age, Continuous
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62.3 years
STANDARD_DEVIATION 9.6 • n=99 Participants
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Sex: Female, Male
Female
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23 Participants
n=99 Participants
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Sex: Female, Male
Male
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7 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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30 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=99 Participants
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Race (NIH/OMB)
White
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26 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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30 Participants
n=99 Participants
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Time since lung cancer diagnosis
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4.62 years
STANDARD_DEVIATION 4.06 • n=99 Participants
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PRIMARY outcome
Timeframe: Post-intervention (approximately 8 weeks)Population: Individuals who were eligible for consent.
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=34 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Feasibility as Measured by Study Accrual
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31 Participants
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PRIMARY outcome
Timeframe: Post-intervention (approximately 8 weeks)Adherence will be shown by at least 80% of intervention sessions completed.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
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27 Participants
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PRIMARY outcome
Timeframe: Post-intervention (approximately 8 weeks)Treatment feasibility will be shown by no more than 25% study attrition.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Feasibility as Measured by Number of Participants Lost From the Study Over Time
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4 Participants
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PRIMARY outcome
Timeframe: Post-intervention (approximately 8 weeks)Population: Participants who completed the CSQ.
CSQ items are rated on a 4-point scale from 1 (quite dissatisfied) to 4 (very satisfied), then averaged to obtain an overall acceptability score. Acceptability was demonstrated by \>80% of participants reporting intervention satisfaction (an average CSQ score of 3 to 4). Reported as the number of participants who had an average CSQ score of 3 to 4.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=26 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
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25 Participants
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PRIMARY outcome
Timeframe: Baseline, post-intervention (approximately week 0, week 8, week 12)Population: Participants who completed the PROMIS Depression Short Form Scale.
Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Psychological Distress as Measured by the PROMIS Depression Short Form Scales
Baseline
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51.82 score on a scale
Standard Deviation 9.16
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Psychological Distress as Measured by the PROMIS Depression Short Form Scales
Week 8
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48.85 score on a scale
Standard Deviation 8.69
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Psychological Distress as Measured by the PROMIS Depression Short Form Scales
Week 12
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48.18 score on a scale
Standard Deviation 9.73
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PRIMARY outcome
Timeframe: Baseline, post-intervention (approximately week 0, week 8, week 12)Population: Participants who completed the PROMIS Anxiety Short Form Scale.
Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=29 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
Baseline
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54.03 score on a scale
Standard Deviation 8.25
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Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
Week 8
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51.75 score on a scale
Standard Deviation 7.51
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Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
Week 12
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48.39 score on a scale
Standard Deviation 8.82
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SECONDARY outcome
Timeframe: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)Population: Participants who completed the FSI.
Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI). The FSI has a score range of 0 to 10, where a higher score indicates more fatigue.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
Baseline
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3.86 score on a scale
Standard Deviation 1.80
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Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
Week 8
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3.36 score on a scale
Standard Deviation 2.03
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Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
Week 12
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3.14 score on a scale
Standard Deviation 2.24
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SECONDARY outcome
Timeframe: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)Population: Participants who completed the MMRCDS.
Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS). The MMRCDS has a score range of 0 to 4, where a higher score indicates worse dyspnea.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Change in Dyspnea
Baseline
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0.97 score on a scale
Standard Deviation 0.87
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Change in Dyspnea
Week 8
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1.20 score on a scale
Standard Deviation 1.08
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Change in Dyspnea
Week 12
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1.00 score on a scale
Standard Deviation 1.02
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SECONDARY outcome
Timeframe: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)Population: Participants who completed the BPI-SF.
The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain severity.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Baseline
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1.84 score on a scale
Standard Deviation 1.80
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Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Week 8
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1.48 score on a scale
Standard Deviation 1.78
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Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Week 12
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1.74 score on a scale
Standard Deviation 1.97
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SECONDARY outcome
Timeframe: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)Population: Participants who completed the BPI-SF.
The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain interference.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Baseline
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1.99 score on a scale
Standard Deviation 2.06
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Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Week 8
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1.91 score on a scale
Standard Deviation 2.36
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Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Week 12
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1.64 score on a scale
Standard Deviation 2.01
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SECONDARY outcome
Timeframe: Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)Population: Participants who completed the DERS-18.
The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation. The DERS-18 has a score range of 18-80, where a higher score indicates greater difficulty with regulating emotions.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)
Baseline
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32.33 score on a scale
Standard Deviation 9.75
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Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)
Week 8
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28.73 score on a scale
Standard Deviation 7.57
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Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)
Week 12
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27.96 score on a scale
Standard Deviation 7.50
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SECONDARY outcome
Timeframe: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)Population: Participants who completed the IUS.
The Intolerance of Uncertainty Short Form (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations. The IUS has a score range of 12-60, where a higher score indicates greater intolerance of uncertainty.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)
Baseline
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25.50 score on a scale
Standard Deviation 7.89
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Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)
Week 8
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20.62 score on a scale
Standard Deviation 4.82
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Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)
Week 12
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20.88 score on a scale
Standard Deviation 7.12
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SECONDARY outcome
Timeframe: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)Population: Participants who completed the DBT-WCCL-DSS.
The DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS) will be used to assess patient-reported frequency of skill use to manage difficult situations. The DBT-WCCL has a score range of 0 to 4, where a higher score indicates greater DBT skill use.
Outcome measures
| Measure |
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
n=30 Participants
The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
Dialectical Behavioral Therapy Skills Training: LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
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Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)
Baseline
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1.95 score on a scale
Standard Deviation 0.44
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Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)
Week 8
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2.24 score on a scale
Standard Deviation 0.44
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Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)
Week 12
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2.25 score on a scale
Standard Deviation 0.43
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Adverse Events
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place