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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
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The purpose of this study to test measures of physical and psychological resilience while using Self-System therapy (SST), to treat depression and lung-cancer-related distress in older adults (65 years and older).
The investigator will examine the feasibility of delivering measures of psychological and physical resilience while delivering the SST intervention. The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall physical functioning in older adults with advanced lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with Advanced Lung Cancer | Experimental | Older adults with stage III or stage IV lung cancer will be enrolled in the Self-System Therapy intervention to treat illness-related distress, depression, and to enhance self-efficacy via delivery of behavioral coping skills across a period of 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience | Behavioral | The SST-LC is a brief structured intervention deliverable by video conference. The SST-LC Resilience protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors. The focus will be to test measures of resilience during the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Confidence in Behavior as Measured by the Cancer Behavior Inventory | The Cancer Behavior Inventory measure will be used for rating confidence in behavior. The measure consist of 12 items. Scores range from 12-108 with higher scores indicating greater confidence. | Baseline, 8 weeks, 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced) | The Brief COPE measure will be used for rating coping skills related to stress. The measure consists of 28 items. Scores range from 28-112 with higher scores indicating lower stress. | Baseline, 8 weeks, 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Ramos, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults With Advanced Lung Cancer | Older adults with stage III or stage IV lung cancer will be enrolled in the Self-System Therapy intervention to treat illness-related distress, depression, and to enhance self-efficacy via delivery of behavioral coping skills across a period of 10 weeks. Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience: The SST-LC is a brief structured intervention deliverable by video conference. The SST-LC Resilience protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors. The focus will be to test measures of resilience during the intervention period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults With Advanced Lung Cancer | Older adults with stage III or stage IV lung cancer will be enrolled in the Self-System Therapy intervention to treat illness-related distress, depression, and to enhance self-efficacy via delivery of behavioral coping skills across a period of 10 weeks. Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience: The SST-LC is a brief structured intervention deliverable by video conference. The SST-LC Resilience protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors. The focus will be to test measures of resilience during the intervention period. |
| 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 | Confidence in Behavior as Measured by the Cancer Behavior Inventory | The Cancer Behavior Inventory measure will be used for rating confidence in behavior. The measure consist of 12 items. Scores range from 12-108 with higher scores indicating greater confidence. | Data not collected on 5 participants at 8 weeks or at 10 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 10 weeks |
|
Up to 10 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 | Adults With Advanced Lung Cancer | Older adults with stage III or stage IV lung cancer will be enrolled in the Self-System Therapy intervention to treat illness-related distress, depression, and to enhance self-efficacy via delivery of behavioral coping skills across a period of 10 weeks. Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience: The SST-LC is a brief structured intervention deliverable by video conference. The SST-LC Resilience protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors. The focus will be to test measures of resilience during the intervention period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Ramos, Ph.D. | Duke University | 919-416-3434 | Katherine.Ramos@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 10, 2022 | Feb 24, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 22, 2021 | Jan 28, 2022 | 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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| ID | Term |
|---|---|
| D000375 | Aging |
| ID | Term |
|---|---|
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
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| Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale) |
The CD-RISC-25 will be used for measuring resilience. The measure consists of 25 items with a scaling of 0-4. Scores range from 0-100, with higher scores being an indicator of higher resilience. |
| Baseline, 8 weeks, 10 weeks |
| Depression as Measured by the Beck Depression Inventory (BDI-II) | Depression will be measured using the Beck Depression Inventory (BDI-II). The measure consists of 21 items. The BDIII is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3 with a total score range of 0 to 63. Higher scores indicate greater depression. | Baseline, 8 weeks, 10 weeks |
| Positive Affect as Measured by the PANAS (Positive and Negative Scale) | The PANAS measure will be used for rating to measure positive affect. Scores range from 10-50, with higher scores indicating higher positive affect. | Baseline, 8 weeks, 10 weeks |
| Negative Affect as Measured by the PANAS (Positive and Negative Scale) | The PANAS measure will be used for rating to measure negative affect. Scores range from 10-50, with higher scores indicating higher negative affect. | Baseline, 8 weeks, 10 weeks |
| Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly) | Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE). The instrument is comprised of 12 self-reported occupational, household and leisure activities items over a one-week period. The total PASE score is computed by multiplying either the time spent in each activity (hours per week) or participation (i.e., yes/no) in an activity, by empirically derived item weights and then summing overall activities. The PASE instrument uses frequency, duration, and intensity level of activity over the previous week to assign a score. The overall PASE score ranges from 0 to 793, where a higher score indicates more physical activity. | Baseline, 8 weeks, 10 weeks |
| Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference) | The Pain Interference PROMIS Scale measure will be used for rating pain interference in daily living. The measure consists of 6 items. Scores range from 6-30, with higher scores indicating higher pain interference. | Baseline, 8 weeks, 10 weeks |
| Number of Participants Who Completed the QUALE (Quality of Life at the End of Life) | The Quality-of-Life measure consists of 26 items. Scores range from 26-130, with higher scores indicating higher quality of life. The measure will be offered to assess how many total participants complete the measure in its entirety. | Baseline, 8 weeks, 10 weeks |
| 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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| Secondary | Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced) | The Brief COPE measure will be used for rating coping skills related to stress. The measure consists of 28 items. Scores range from 28-112 with higher scores indicating lower stress. | Data not collected on 5 participants at 8 weeks or at 10 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 10 weeks |
|
|
|
| Secondary | Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale) | The CD-RISC-25 will be used for measuring resilience. The measure consists of 25 items with a scaling of 0-4. Scores range from 0-100, with higher scores being an indicator of higher resilience. | Data not collected on 5 participants at 8 weeks or at 10 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 10 weeks |
|
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| Secondary | Depression as Measured by the Beck Depression Inventory (BDI-II) | Depression will be measured using the Beck Depression Inventory (BDI-II). The measure consists of 21 items. The BDIII is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3 with a total score range of 0 to 63. Higher scores indicate greater depression. | Data not collected on 5 participants at 8 weeks or at 10 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 10 weeks |
|
|
|
| Secondary | Positive Affect as Measured by the PANAS (Positive and Negative Scale) | The PANAS measure will be used for rating to measure positive affect. Scores range from 10-50, with higher scores indicating higher positive affect. | Data not collected on 5 participants at 8 weeks or at 10 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 10 weeks |
|
|
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| Secondary | Negative Affect as Measured by the PANAS (Positive and Negative Scale) | The PANAS measure will be used for rating to measure negative affect. Scores range from 10-50, with higher scores indicating higher negative affect. | Data not collected on 5 participants at 8 weeks or at 10 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 10 weeks |
|
|
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| Secondary | Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly) | Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE). The instrument is comprised of 12 self-reported occupational, household and leisure activities items over a one-week period. The total PASE score is computed by multiplying either the time spent in each activity (hours per week) or participation (i.e., yes/no) in an activity, by empirically derived item weights and then summing overall activities. The PASE instrument uses frequency, duration, and intensity level of activity over the previous week to assign a score. The overall PASE score ranges from 0 to 793, where a higher score indicates more physical activity. | Data not collected on 5 participants at 8 weeks or at 10 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 10 weeks |
|
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| Secondary | Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference) | The Pain Interference PROMIS Scale measure will be used for rating pain interference in daily living. The measure consists of 6 items. Scores range from 6-30, with higher scores indicating higher pain interference. | Data not collected. | Posted | Baseline, 8 weeks, 10 weeks |
|
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| Secondary | Number of Participants Who Completed the QUALE (Quality of Life at the End of Life) | The Quality-of-Life measure consists of 26 items. Scores range from 26-130, with higher scores indicating higher quality of life. The measure will be offered to assess how many total participants complete the measure in its entirety. | Posted | Count of Participants | Participants | Baseline, 8 weeks, 10 weeks |
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| 3 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 10 weeks |
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| 10 weeks |
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| 10 weeks |
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| 10 weeks |
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| 10 weeks |
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| 10 weeks |
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| Title | Measurements |
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