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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialectical Behavioral Therapy Skills Training | Behavioral | LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Measured by Study Accrual | Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot) | Post-intervention (approximately 8 weeks) |
| Adherence as Measured by Number of Participants Who Completed All Intervention Sessions | Adherence will be shown by at least 80% of intervention sessions completed. | Post-intervention (approximately 8 weeks) |
| 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. | Post-intervention (approximately 8 weeks) |
| 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. | Post-intervention (approximately 8 weeks) |
| 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. | Baseline, post-intervention (approximately week 0, week 8, week 12) |
| Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Somers, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41392376 | Derived | Hyland KA, Neacsiu AD, Fisher HM, Cowperthwait CM, Chou N, Stinchcombe TE, Oeffinger KC, Porter LS, Dorfman CS, Keefe FJ, Somers TJ. LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients With Metastatic Non-Small Cell Lung Cancer. Psychooncology. 2025 Dec;34(12):e70357. doi: 10.1002/pon.70357. |
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One participant was lost to contact prior to baseline assessment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility as Measured by Study Accrual | Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot) | Individuals who were eligible for consent. | Posted | Count of Participants | Participants | Post-intervention (approximately 8 weeks) |
|
Up to approximately 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Somers, PhD | Duke University School of Medicine | 9194163408 | tamara.somers@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2024 | Mar 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2023 | Jan 31, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Single Group Assignment
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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. |
| Baseline, post-intervention (approximately week 0, week 8, week 12) |
| 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. | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
| 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. | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
| 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. | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
| 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. | Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12) |
| 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. | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
| 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. | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Time since lung cancer diagnosis | Mean | Standard Deviation | years |
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| 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. | Posted | Count of Participants | Participants | Post-intervention (approximately 8 weeks) |
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| 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. | Posted | Count of Participants | Participants | Post-intervention (approximately 8 weeks) |
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| 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. | Participants who completed the CSQ. | Posted | Count of Participants | Participants | Post-intervention (approximately 8 weeks) |
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| 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. | Participants who completed the PROMIS Depression Short Form Scale. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (approximately week 0, week 8, week 12) |
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| 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. | Participants who completed the PROMIS Anxiety Short Form Scale. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (approximately week 0, week 8, week 12) |
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| 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. | Participants who completed the FSI. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
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| 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. | Participants who completed the MMRCDS. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
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| 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. | Participants who completed the BPI-SF. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
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| 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. | Participants who completed the BPI-SF. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
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| 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. | Participants who completed the DERS-18. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12) |
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| 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. | Participants who completed the IUS. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
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| 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. | Participants who completed the DBT-WCCL-DSS. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) |
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| 2 |
| 30 |
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| 30 |
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| 30 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Week 12 |
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