Lung Cancer Stage III, Lung Cancer Stage IV
Conditions
Brief summary
The purpose of this study to use 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 whether delivering the SST intervention will be both feasible and acceptable to study participants. The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall functioning in older adults with advanced lung cancer.
Interventions
BEHAVIORALSelf-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)
The SST-LC is a brief structured intervention deliverable by video conference. The new SST-LC 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.
Sponsors
National Institutes of Health (NIH)
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 years * English-speaking * The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at her/his 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 |
|---|---|---|
| Number of Patients That Complete SST Treatment Sessions | up to week 12 | Completion of at least 85% of SST treatment sessions across a 12-week period. |
| Patient Satisfaction With Treatment | End of study, week 12 | The Client Satisfaction Questionnaire (CSQ-8), which assesses treatment credibility (pre-treatment) and effectiveness of/satisfaction with services (post-treatment). An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores therefore range from 8 to 32, with higher values indicating higher satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Distress as Measured by the CORE-10 at 1-month Follow-up | 1-month follow-up, up to 4 months | The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress. |
| Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline | Baseline | Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The total score ranges from 0 to 63, where higher scores indicate greater depression. |
| Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks | 12 weeks | Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The total score ranges from 0 to 63, where higher scores indicate greater depression. |
| Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up | 1-month follow-up, up to 4 months | Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The total score ranges from 0 to 63, where higher scores indicate greater depression. |
| Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L) | Baseline, 12 weeks, 1 month follow-up (up to 4 months) | Functioning will be measured using the Functional Assessment of Cancer Therapy- Lung (FACT-L). The FACT-L is a 36-item measure, each item with a five-point scale from 0 (not at all) to 4 (very much), measuring overall quality of life (QOL) across five dimensions that are summed together to derive a total score. The total score range is from 0-136. The higher the score, the better the QOL. |
| General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline | Baseline | The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress. |
| Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available | Baseline, 12 weeks, 1 month follow-up (up to 4 months) | Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE)The instrument is comprised of self-reported occupational, household and leisure activities items over a one-week period. PASE scores are calculated from weights and frequency values for each of 12 types of activity. |
| Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline | Baseline | Self-Discrepancy will be measured using the Computerized Selves Questionnaire (CSQ). The CSQ is a computer-based version of the original self-discrepancy questionnaire used by Higgins and colleagues (1986) in which a person is asked to produce a list of eight personal attributes that s/he would ideally like to possess and eight attributes s/he feels s/he ought to possess. To score, qualities in the actual self column are compared with those in the ought self column. |
| Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline | Baseline | Self-Regulatory Orientation will be measured using the Regulatory Focus Questionnaire (RFQ).The measure has 11 items using 5-point scales, along two sub scales measuring the extent to which an individual believes s/he has been successful in attaining promotion or prevention goals. Six questions quantify Promotion and five questions quantify Prevention the promotion sums must be divided by 6, and the prevention sums must be divided by 5 in order to place scores for both orientations on the same 1-5 scale. |
| Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills. | End of study, week 12 | Trained raters will listen to audio recordings of treatment sessions and use a pre-defined checklist of session content and strategies of the treatment to indicate if session coping skills were taught (yes/no) coded as 1 for yes and 0 for no. Higher scores indicate greater session fidelity. |
| Number of Participants With Participant-reported Mobility Indices Available | Baseline, 12 weeks, 1 month follow-up (up to 4 months) | Mobility indices will include participant report of difficulty walking across a room without help from another person or equipment (none, a little vs some, a lot, unable), difficulty walking two to three blocks without help from another person or equipment (none, a little vs some, a lot, unable), and use of assistive device (yes vs no). |
| General Distress as Measured by the CORE-10 at 12 Weeks | 12 weeks | The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress. |
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 12 weeks.
Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC): The SST-LC is a brief structured intervention deliverable by video conference. The new SST-LC 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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Adults With Advanced Lung Cancer |
|---|---|
| Age, Continuous | 69.77 years STANDARD_DEVIATION 4.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 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 | 26 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 3 / 30 |
Outcome results
Primary
Number of Patients That Complete SST Treatment Sessions
Completion of at least 85% of SST treatment sessions across a 12-week period.
Time frame: up to week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adults With Advanced Lung Cancer | Number of Patients That Complete SST Treatment Sessions | 23 Participants |
Primary
Patient Satisfaction With Treatment
The Client Satisfaction Questionnaire (CSQ-8), which assesses treatment credibility (pre-treatment) and effectiveness of/satisfaction with services (post-treatment). An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores therefore range from 8 to 32, with higher values indicating higher satisfaction.
Time frame: End of study, week 12
Population: Data not collected on 7 participants (3 withdrew prior to the study, 3 completed less than 8 sessions, and one who died from their lung cancer and could not complete).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Advanced Lung Cancer | Patient Satisfaction With Treatment | 30.78 score on a scale | Standard Deviation 1.78 |
Secondary
Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks
Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The total score ranges from 0 to 63, where higher scores indicate greater depression.
Time frame: 12 weeks
Population: Seven participants had been withdrawn from the study at 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Advanced Lung Cancer | Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks | 6.17 score on a scale | Standard Deviation 6.07 |
Secondary
Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up
Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The total score ranges from 0 to 63, where higher scores indicate greater depression.
Time frame: 1-month follow-up, up to 4 months
Population: Nine participants did not complete due to withdrawal or death.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Advanced Lung Cancer | Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up | 6.13 score on a scale | Standard Deviation 5.1 |
Secondary
Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline
Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The total score ranges from 0 to 63, where higher scores indicate greater depression.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Advanced Lung Cancer | Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline | 9.41 score on a scale | Standard Deviation 6.09 |
Secondary
Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L)
Functioning will be measured using the Functional Assessment of Cancer Therapy- Lung (FACT-L). The FACT-L is a 36-item measure, each item with a five-point scale from 0 (not at all) to 4 (very much), measuring overall quality of life (QOL) across five dimensions that are summed together to derive a total score. The total score range is from 0-136. The higher the score, the better the QOL.
Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Population: Participants with FACT-L scores available at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Advanced Lung Cancer | Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L) | 12 weeks | 109.12 score on a scale | Standard Deviation 16.01 |
| Adults With Advanced Lung Cancer | Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L) | 1 month follow-up | 101.47 score on a scale | Standard Deviation 17.51 |
| Adults With Advanced Lung Cancer | Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L) | Baseline | 102.22 score on a scale | Standard Deviation 16.71 |
Secondary
General Distress as Measured by the CORE-10 at 12 Weeks
The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.
Time frame: 12 weeks
Population: Seven participants had been withdrawn from the study at 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Advanced Lung Cancer | General Distress as Measured by the CORE-10 at 12 Weeks | 12.67 score on a scale | Standard Deviation 3.62 |
Secondary
General Distress as Measured by the CORE-10 at 1-month Follow-up
The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.
Time frame: 1-month follow-up, up to 4 months
Population: Nine participants did not complete due to withdrawal or death.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Advanced Lung Cancer | General Distress as Measured by the CORE-10 at 1-month Follow-up | 12.30 score on a scale | Standard Deviation 3.6 |
Secondary
General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline
The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Advanced Lung Cancer | General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline | 14.55 score on a scale | Standard Deviation 3.93 |
Secondary
Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline
Self-Discrepancy will be measured using the Computerized Selves Questionnaire (CSQ). The CSQ is a computer-based version of the original self-discrepancy questionnaire used by Higgins and colleagues (1986) in which a person is asked to produce a list of eight personal attributes that s/he would ideally like to possess and eight attributes s/he feels s/he ought to possess. To score, qualities in the actual self column are compared with those in the ought self column.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adults With Advanced Lung Cancer | Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline | 30 Participants |
Secondary
Number of Participants With Participant-reported Mobility Indices Available
Mobility indices will include participant report of difficulty walking across a room without help from another person or equipment (none, a little vs some, a lot, unable), difficulty walking two to three blocks without help from another person or equipment (none, a little vs some, a lot, unable), and use of assistive device (yes vs no).
Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults With Advanced Lung Cancer | Number of Participants With Participant-reported Mobility Indices Available | Baseline | 30 Participants |
| Adults With Advanced Lung Cancer | Number of Participants With Participant-reported Mobility Indices Available | 12 weeks | 23 Participants |
| Adults With Advanced Lung Cancer | Number of Participants With Participant-reported Mobility Indices Available | 1 month follow-up | 21 Participants |
Secondary
Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available
Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE)The instrument is comprised of self-reported occupational, household and leisure activities items over a one-week period. PASE scores are calculated from weights and frequency values for each of 12 types of activity.
Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults With Advanced Lung Cancer | Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available | Baseline | 30 Participants |
| Adults With Advanced Lung Cancer | Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available | 12 weeks | 23 Participants |
| Adults With Advanced Lung Cancer | Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available | 1 month follow-up | 21 Participants |
Secondary
Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline
Self-Regulatory Orientation will be measured using the Regulatory Focus Questionnaire (RFQ).The measure has 11 items using 5-point scales, along two sub scales measuring the extent to which an individual believes s/he has been successful in attaining promotion or prevention goals. Six questions quantify Promotion and five questions quantify Prevention the promotion sums must be divided by 6, and the prevention sums must be divided by 5 in order to place scores for both orientations on the same 1-5 scale.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adults With Advanced Lung Cancer | Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline | 30 Participants |
Secondary
Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills.
Trained raters will listen to audio recordings of treatment sessions and use a pre-defined checklist of session content and strategies of the treatment to indicate if session coping skills were taught (yes/no) coded as 1 for yes and 0 for no. Higher scores indicate greater session fidelity.
Time frame: End of study, week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adults With Advanced Lung Cancer | Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills. | 24 Participants |