Self-System Therapy for Older Adults With Lung Cancer

Lung Cancer Stage IV Clinical Trial

Official title:

Self-System Therapy for Older Adults With Advanced Lung Cancer (SST-LC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057196
• Other study ID #: Pro00102705
• Status: Completed
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: June 24, 2021

Study information

• Verified date: July 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 24, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer Stage III
• Lung Cancer Stage IV
• Lung Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Strauman TJ, Eddington KM. Treatment of Depression From a Self-Regulation Perspective: Basic Concepts and Applied Strategies in Self-System Therapy. Cognit Ther Res. 2017 Feb;41(1):1-15. doi: 10.1007/s10608-016-9801-1. Epub 2016 Aug 29. — View Citation

Waters SJ, Strauman TJ, McKee DC, Campbell LC, Shelby RA, Dixon KE, Fras AM, Keefe FJ. Self-system therapy for distress associated with persistent low back pain: A randomized clinical trial. Psychother Res. 2016 Jul;26(4):472-83. doi: 10.1080/10503307.2015.1040485. Epub 2015 Jun 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients That Complete SST Treatment Sessions	Completion of at least 85% of SST treatment sessions across a 12-week period.	up to week 12
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.	End of study, week 12
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.	Baseline
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.	12 weeks
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.	1-month follow-up, up to 4 months
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.	Baseline
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.	12 weeks
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.	1-month follow-up, up to 4 months
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.	Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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).	Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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.	Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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.	Baseline
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.	Baseline
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.	End of study, week 12