Trial Outcomes & Findings for Resilience Measurement in Older Adults With Late-Stage Lung Cancer (NCT NCT04825912)
NCT ID: NCT04825912
Last Updated: 2024-02-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Baseline, 8 weeks, 10 weeks
Results posted on
2024-02-02
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
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18
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Death
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3
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Resilience Measurement in Older Adults With Late-Stage Lung Cancer
Baseline characteristics by cohort
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Age, Continuous
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70.6 years
STANDARD_DEVIATION 3.976 • n=99 Participants
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Sex: Female, Male
Female
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10 Participants
n=99 Participants
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Sex: Female, Male
Male
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8 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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18 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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2 Participants
n=99 Participants
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Race (NIH/OMB)
White
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16 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 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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18 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksPopulation: Data not collected on 5 participants at 8 weeks or at 10 weeks.
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.
Outcome measures
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Confidence in Behavior as Measured by the Cancer Behavior Inventory
Baseline
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80.89 score on a scale
Standard Deviation 21.13
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Confidence in Behavior as Measured by the Cancer Behavior Inventory
8 weeks
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85.92 score on a scale
Standard Deviation 13.97
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Confidence in Behavior as Measured by the Cancer Behavior Inventory
10 weeks
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93.23 score on a scale
Standard Deviation 11.19
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SECONDARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksPopulation: Data not collected on 5 participants at 8 weeks or at 10 weeks.
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.
Outcome measures
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)
Baseline
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55.72 score on a scale
Standard Deviation 10.29
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Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)
8 weeks
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58.54 score on a scale
Standard Deviation 11.70
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Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)
10 weeks
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57.62 score on a scale
Standard Deviation 14.23
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SECONDARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksPopulation: Data not collected on 5 participants at 8 weeks or at 10 weeks.
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.
Outcome measures
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)
Baseline
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73.16 score on a scale
Standard Deviation 15.06
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Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)
8 weeks
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75.69 score on a scale
Standard Deviation 7.67
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Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)
10 weeks
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78.00 score on a scale
Standard Deviation 9.65
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SECONDARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksPopulation: Data not collected on 5 participants at 8 weeks or at 10 weeks.
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.
Outcome measures
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Depression as Measured by the Beck Depression Inventory (BDI-II)
Baseline
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9.06 score on a scale
Standard Deviation 4.56
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Depression as Measured by the Beck Depression Inventory (BDI-II)
8 weeks
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7.92 score on a scale
Standard Deviation 5.09
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Depression as Measured by the Beck Depression Inventory (BDI-II)
10 weeks
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8.23 score on a scale
Standard Deviation 4.38
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SECONDARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksPopulation: Data not collected on 5 participants at 8 weeks or at 10 weeks.
The PANAS measure will be used for rating to measure positive affect. Scores range from 10-50, with higher scores indicating higher positive affect.
Outcome measures
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Positive Affect as Measured by the PANAS (Positive and Negative Scale)
Baseline
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32.72 score on a scale
Standard Deviation 8.38
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Positive Affect as Measured by the PANAS (Positive and Negative Scale)
8 weeks
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34.61 score on a scale
Standard Deviation 9.49
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Positive Affect as Measured by the PANAS (Positive and Negative Scale)
10 weeks
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36.15 score on a scale
Standard Deviation 7.20
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SECONDARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksPopulation: Data not collected on 5 participants at 8 weeks or at 10 weeks.
The PANAS measure will be used for rating to measure negative affect. Scores range from 10-50, with higher scores indicating higher negative affect.
Outcome measures
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Negative Affect as Measured by the PANAS (Positive and Negative Scale)
10 weeks
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17.54 score on a scale
Standard Deviation 7.80
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Negative Affect as Measured by the PANAS (Positive and Negative Scale)
Baseline
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18.04 score on a scale
Standard Deviation 15.44
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Negative Affect as Measured by the PANAS (Positive and Negative Scale)
8 weeks
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17.31 score on a scale
Standard Deviation 5.60
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SECONDARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksPopulation: Data not collected on 5 participants at 8 weeks or at 10 weeks.
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.
Outcome measures
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)
Baseline
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101.06 score on a scale
Standard Deviation 76.24
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Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)
8 weeks
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110.23 score on a scale
Standard Deviation 82.14
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Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)
10 weeks
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109.17 score on a scale
Standard Deviation 73.50
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SECONDARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksPopulation: Data not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 10 weeksThe 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.
Outcome measures
| Measure |
Adults With Advanced Lung Cancer
n=18 Participants
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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Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)
Baseline
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18 Participants
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Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)
8 weeks
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13 Participants
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Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)
10 weeks
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13 Participants
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Adverse Events
Adults With Advanced Lung Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 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