Lung Cancer Stage III, Lung Cancer Stage IV
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALSelf 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.
Sponsors
Wake Forest University Health Sciences
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 65 or older * English-speaking * The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at his/her home.
Exclusion criteria
* Unable to provide informed consent * Visual or hearing impairments that preclude participation * Serious mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confidence in Behavior as Measured by the Cancer Behavior Inventory | Baseline, 8 weeks, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale) | Baseline, 8 weeks, 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. |
| Depression as Measured by the Beck Depression Inventory (BDI-II) | Baseline, 8 weeks, 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. |
| Positive Affect as Measured by the PANAS (Positive and Negative Scale) | Baseline, 8 weeks, 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. |
| Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced) | Baseline, 8 weeks, 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. |
| Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly) | Baseline, 8 weeks, 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. |
| Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference) | Baseline, 8 weeks, 10 weeks | 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. |
| Number of Participants Who Completed the QUALE (Quality of Life at the End of Life) | Baseline, 8 weeks, 10 weeks | 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. |
| Negative Affect as Measured by the PANAS (Positive and Negative Scale) | Baseline, 8 weeks, 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Adults With Advanced Lung Cancer |
|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 3.976 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 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 | 2 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 16 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: Baseline, 8 weeks, 10 weeks
Population: Data not collected on 5 participants at 8 weeks or at 10 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Advanced Lung Cancer | Confidence in Behavior as Measured by the Cancer Behavior Inventory | Baseline | 80.89 score on a scale | Standard Deviation 21.13 |
| Adults With Advanced Lung Cancer | Confidence in Behavior as Measured by the Cancer Behavior Inventory | 8 weeks | 85.92 score on a scale | Standard Deviation 13.97 |
| Adults With Advanced Lung Cancer | Confidence in Behavior as Measured by the Cancer Behavior Inventory | 10 weeks | 93.23 score on a scale | Standard Deviation 11.19 |
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.
Time frame: Baseline, 8 weeks, 10 weeks
Population: Data not collected on 5 participants at 8 weeks or at 10 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Advanced Lung Cancer | Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced) | Baseline | 55.72 score on a scale | Standard Deviation 10.29 |
| Adults With Advanced Lung Cancer | Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced) | 8 weeks | 58.54 score on a scale | Standard Deviation 11.7 |
| Adults With Advanced Lung Cancer | Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced) | 10 weeks | 57.62 score on a scale | Standard Deviation 14.23 |
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.
Time frame: Baseline, 8 weeks, 10 weeks
Population: Data not collected on 5 participants at 8 weeks or at 10 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Advanced Lung Cancer | Depression as Measured by the Beck Depression Inventory (BDI-II) | Baseline | 9.06 score on a scale | Standard Deviation 4.56 |
| Adults With Advanced Lung Cancer | Depression as Measured by the Beck Depression Inventory (BDI-II) | 8 weeks | 7.92 score on a scale | Standard Deviation 5.09 |
| Adults With Advanced Lung Cancer | Depression as Measured by the Beck Depression Inventory (BDI-II) | 10 weeks | 8.23 score on a scale | Standard Deviation 4.38 |
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.
Time frame: Baseline, 8 weeks, 10 weeks
Population: Data not collected on 5 participants at 8 weeks or at 10 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Advanced Lung Cancer | Negative Affect as Measured by the PANAS (Positive and Negative Scale) | Baseline | 18.04 score on a scale | Standard Deviation 15.44 |
| Adults With Advanced Lung Cancer | Negative Affect as Measured by the PANAS (Positive and Negative Scale) | 8 weeks | 17.31 score on a scale | Standard Deviation 5.6 |
| Adults With Advanced Lung Cancer | Negative Affect as Measured by the PANAS (Positive and Negative Scale) | 10 weeks | 17.54 score on a scale | Standard Deviation 7.8 |
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.
Time frame: Baseline, 8 weeks, 10 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults With Advanced Lung Cancer | Number of Participants Who Completed the QUALE (Quality of Life at the End of Life) | Baseline | 18 Participants |
| Adults With Advanced Lung Cancer | Number of Participants Who Completed the QUALE (Quality of Life at the End of Life) | 8 weeks | 13 Participants |
| Adults With Advanced Lung Cancer | Number of Participants Who Completed the QUALE (Quality of Life at the End of Life) | 10 weeks | 13 Participants |
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.
Time frame: Baseline, 8 weeks, 10 weeks
Population: Data not collected.
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.
Time frame: Baseline, 8 weeks, 10 weeks
Population: Data not collected on 5 participants at 8 weeks or at 10 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Advanced Lung Cancer | Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly) | Baseline | 101.06 score on a scale | Standard Deviation 76.24 |
| Adults With Advanced Lung Cancer | Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly) | 8 weeks | 110.23 score on a scale | Standard Deviation 82.14 |
| Adults With Advanced Lung Cancer | Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly) | 10 weeks | 109.17 score on a scale | Standard Deviation 73.5 |
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.
Time frame: Baseline, 8 weeks, 10 weeks
Population: Data not collected on 5 participants at 8 weeks or at 10 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Advanced Lung Cancer | Positive Affect as Measured by the PANAS (Positive and Negative Scale) | Baseline | 32.72 score on a scale | Standard Deviation 8.38 |
| Adults With Advanced Lung Cancer | Positive Affect as Measured by the PANAS (Positive and Negative Scale) | 8 weeks | 34.61 score on a scale | Standard Deviation 9.49 |
| Adults With Advanced Lung Cancer | Positive Affect as Measured by the PANAS (Positive and Negative Scale) | 10 weeks | 36.15 score on a scale | Standard Deviation 7.2 |
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.
Time frame: Baseline, 8 weeks, 10 weeks
Population: Data not collected on 5 participants at 8 weeks or at 10 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Advanced Lung Cancer | Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale) | Baseline | 73.16 score on a scale | Standard Deviation 15.06 |
| Adults With Advanced Lung Cancer | Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale) | 8 weeks | 75.69 score on a scale | Standard Deviation 7.67 |
| Adults With Advanced Lung Cancer | Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale) | 10 weeks | 78.00 score on a scale | Standard Deviation 9.65 |