Self-System Therapy for Older Adults With Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer Stage IV; Lung Cancer Stage III
• Interventions: Behavioral: Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)

• Registration Number: NCT04057196
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Study Start: 2020-04-02
• Primary Completion: 2021-05-20
• Study Completion: 2021-06-24
• Results First Submitted: 2022-05-20
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-08
• Last Update Submitted: 2022-07-08
• Results First Posted: 2022-08-03
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

• Unable to provide informed consent
• Visual or hearing impairments that preclude participation
• Serious mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults with Advanced Lung Cancer	Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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).
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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States