Trial Outcomes & Findings for Self-System Therapy for Older Adults With Lung Cancer (NCT NCT04057196)

Results Overview

Completion of at least 85% of SST treatment sessions across a 12-week period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

up to week 12

Results posted on

2022-08-03

Participant Flow

Participant milestones

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 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.
Overall Study STARTED	30
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	6

Reasons for withdrawal

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 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.
Overall Study Withdrawal by Subject	3
Overall Study Death	3

Baseline Characteristics

Self-System Therapy for Older Adults With Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults With Advanced Lung Cancer n=30 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 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.
Age, Continuous	69.77 years STANDARD_DEVIATION 4.95 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to week 12

Completion of at least 85% of SST treatment sessions across a 12-week period.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
Number of Patients That Complete SST Treatment Sessions	23 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=23 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 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.
Patient Satisfaction With Treatment	30.78 score on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
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 outcome

Timeframe: 12 weeks

Population: Seven participants had been withdrawn from the study 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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=23 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 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.
General Distress as Measured by the CORE-10 at 12 Weeks	12.67 score on a scale Standard Deviation 3.62

SECONDARY outcome

Timeframe: 1-month follow-up, up to 4 months

Population: Nine participants did not complete due to withdrawal or death.

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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=21 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 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.
General Distress as Measured by the CORE-10 at 1-month Follow-up	12.30 score on a scale Standard Deviation 3.60

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline	9.41 score on a scale Standard Deviation 6.09

SECONDARY outcome

Timeframe: 12 weeks

Population: Seven participants had been withdrawn from the study 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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=23 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 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.
Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks	6.17 score on a scale Standard Deviation 6.07

SECONDARY outcome

Timeframe: 1-month follow-up, up to 4 months

Population: Nine participants did not complete due to withdrawal or death.

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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=21 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 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.
Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up	6.13 score on a scale Standard Deviation 5.10

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 1 month follow-up (up to 4 months)

Population: Participants with FACT-L scores available at each time point.

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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
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
Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L) Baseline	102.22 score on a scale Standard Deviation 16.71
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

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
Number of Participants With Participant-reported Mobility Indices Available Baseline	30 Participants
Number of Participants With Participant-reported Mobility Indices Available 12 weeks	23 Participants
Number of Participants With Participant-reported Mobility Indices Available 1 month follow-up	21 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available Baseline	30 Participants
Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available 12 weeks	23 Participants
Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available 1 month follow-up	21 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline	30 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline	30 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adults With Advanced Lung Cancer n=30 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 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.
Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills.	24 Participants

Adverse Events

Adults With Advanced Lung Cancer

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Adults With Advanced Lung Cancer n=30 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Unfavorable changes in health, due to disease progression	10.0% 3/30 • At 12 weeks and 1-month follow-up. Reporting of patients with late-stage lung cancer who died due to progressing illness, not linked to participation in SST-LC behavioral intervention.

Other adverse events

Adverse event data not reported

Additional Information

Katherine Ramos, Ph.D.

Duke University

Phone: 919-416-3434

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place