Lung Cancer Metastatic
Conditions
Keywords
dialectical behavioral therapy skills training, lung cancer
Brief summary
Metastatic lung cancer patients experience significantly greater psychological distress (i.e., depression, anxiety) compared to other cancers. Psychological distress is as a prognostic indicator for worse clinical outcomes and poorer overall survival in cancer patients. Dialectical behavioral therapy (DBT) is a trans-diagnostic, evidence-based psychotherapy that teaches participants a core set of behavioral skills (distress tolerance, emotion regulation, mindfulness, interpersonal effectiveness) to cope more effectively with emotional and physical symptoms. The proposed study seeks to adapt and pilot test DBT skills training for patients with metastatic lung cancer using the ADAPT-ITT framework. Participants will be metastatic lung cancer patients who score \>=3 on the National Comprehensive Cancer Network distress thermometer. Phase I aims to use focus groups and interviews with key stakeholders (metastatic lung cancer patients (N=20), thoracic oncology providers (N=6), clinicians with expertise in survivorship and behavioral symptom management (N=6)) to determine if and how DBT skills training must be modified for implementation with metastatic lung cancer patients. Adapted material will be reviewed by topical experts in DBT and implementation science to produce a manualized, adapted DBT skills training protocol for metastatic lung cancer patients (LiveWell). Phase II aims to pilot test LiveWell (N=30) to assess feasibility, acceptability, and examine pre-to-post intervention outcomes of psychological distress, (i.e., depression and anxiety) fatigue, dyspnea, pain, emotion regulation, tolerance of uncertainty, and DBT coping skill use. LiveWell will consist of coping skills training sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.
Interventions
LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer 2. be undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute 3. score \>3 on the National Comprehensive Cancer Network Distress Thermometer for distress over the past week (Range: 0-10) 4. be \> 18 years of age 5. be able to understand, speak, and read English 6. be able to provide informed consent
Exclusion criteria
1. reported or suspected cognitive impairment subsequently informed by a Montreal Cognitive Assessment (MOCA) of \<26 2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart, treating oncologist, or other medical provider 3. expected survival of 4 months or less
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Study Accrual | Post-intervention (approximately 8 weeks) | Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot) |
| Adherence as Measured by Number of Participants Who Completed All Intervention Sessions | Post-intervention (approximately 8 weeks) | Adherence will be shown by at least 80% of intervention sessions completed. |
| Feasibility as Measured by Number of Participants Lost From the Study Over Time | Post-intervention (approximately 8 weeks) | Treatment feasibility will be shown by no more than 25% study attrition. |
| Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) | Post-intervention (approximately 8 weeks) | 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. |
| Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales | Baseline, post-intervention (approximately week 0, week 8, week 12) | 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. |
| Psychological Distress as Measured by the PROMIS Depression Short Form Scales | Baseline, post-intervention (approximately week 0, week 8, week 12) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI) | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 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. |
| Change in Dyspnea | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 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. |
| Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain severity. |
| Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain interference. |
| Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18) | Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12) | 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. |
| Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS) | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 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. |
| Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS) | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 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. |
Countries
United States
Participant flow
Pre-assignment details
One participant was lost to contact prior to baseline assessment.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 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 | 3 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 26 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 7 Participants |
| Time since lung cancer diagnosis | 4.62 years STANDARD_DEVIATION 4.06 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Acceptability as Measured by the Client Satisfaction Questionnaire (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.
Time frame: Post-intervention (approximately 8 weeks)
Population: Participants who completed the CSQ.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) | 25 Participants |
Primary
Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
Adherence will be shown by at least 80% of intervention sessions completed.
Time frame: Post-intervention (approximately 8 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Adherence as Measured by Number of Participants Who Completed All Intervention Sessions | 27 Participants |
Primary
Feasibility as Measured by Number of Participants Lost From the Study Over Time
Treatment feasibility will be shown by no more than 25% study attrition.
Time frame: Post-intervention (approximately 8 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Feasibility as Measured by Number of Participants Lost From the Study Over Time | 4 Participants |
Primary
Feasibility as Measured by Study Accrual
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Time frame: Post-intervention (approximately 8 weeks)
Population: Individuals who were eligible for consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Feasibility as Measured by Study Accrual | 31 Participants |
Primary
Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
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.
Time frame: Baseline, post-intervention (approximately week 0, week 8, week 12)
Population: Participants who completed the PROMIS Anxiety Short Form Scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales | Baseline | 54.03 score on a scale | Standard Deviation 8.25 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales | Week 8 | 51.75 score on a scale | Standard Deviation 7.51 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales | Week 12 | 48.39 score on a scale | Standard Deviation 8.82 |
Primary
Psychological Distress as Measured by the PROMIS Depression Short Form Scales
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.
Time frame: Baseline, post-intervention (approximately week 0, week 8, week 12)
Population: Participants who completed the PROMIS Depression Short Form Scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Psychological Distress as Measured by the PROMIS Depression Short Form Scales | Week 12 | 48.18 score on a scale | Standard Deviation 9.73 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Psychological Distress as Measured by the PROMIS Depression Short Form Scales | Baseline | 51.82 score on a scale | Standard Deviation 9.16 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Psychological Distress as Measured by the PROMIS Depression Short Form Scales | Week 8 | 48.85 score on a scale | Standard Deviation 8.69 |
Secondary
Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (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.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Population: Participants who completed the DBT-WCCL-DSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS) | Baseline | 1.95 score on a scale | Standard Deviation 0.44 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | 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 | 2.24 score on a scale | Standard Deviation 0.44 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | 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 | 2.25 score on a scale | Standard Deviation 0.43 |
Secondary
Change in Dyspnea
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.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Population: Participants who completed the MMRCDS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Dyspnea | Baseline | 0.97 score on a scale | Standard Deviation 0.87 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Dyspnea | Week 8 | 1.20 score on a scale | Standard Deviation 1.08 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Dyspnea | Week 12 | 1.00 score on a scale | Standard Deviation 1.02 |
Secondary
Change in Emotion Regulation as Measured by the Emotion Regulation Scale (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.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
Population: Participants who completed the DERS-18.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18) | Baseline | 32.33 score on a scale | Standard Deviation 9.75 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18) | Week 8 | 28.73 score on a scale | Standard Deviation 7.57 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18) | Week 12 | 27.96 score on a scale | Standard Deviation 7.5 |
Secondary
Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (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.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Population: Participants who completed the IUS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS) | Baseline | 25.50 score on a scale | Standard Deviation 7.89 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS) | Week 8 | 20.62 score on a scale | Standard Deviation 4.82 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS) | Week 12 | 20.88 score on a scale | Standard Deviation 7.12 |
Secondary
Fatigue Severity as Measured by the Fatigue Symptom Inventory (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.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Population: Participants who completed the FSI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI) | Baseline | 3.86 score on a scale | Standard Deviation 1.8 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI) | Week 8 | 3.36 score on a scale | Standard Deviation 2.03 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI) | Week 12 | 3.14 score on a scale | Standard Deviation 2.24 |
Secondary
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain interference.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Population: Participants who completed the BPI-SF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | Baseline | 1.99 score on a scale | Standard Deviation 2.06 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | Week 8 | 1.91 score on a scale | Standard Deviation 2.36 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | Week 12 | 1.64 score on a scale | Standard Deviation 2.01 |
Secondary
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain severity.
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Population: Participants who completed the BPI-SF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | Baseline | 1.84 score on a scale | Standard Deviation 1.8 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | Week 8 | 1.48 score on a scale | Standard Deviation 1.78 |
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | Week 12 | 1.74 score on a scale | Standard Deviation 1.97 |