- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04057196
Self-System Therapy for Older Adults With Lung Cancer
July 8, 2022 updated by: Duke University
Self-System Therapy for Older Adults With Advanced Lung Cancer (SST-LC)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients That Complete SST Treatment Sessions
Time Frame: up to week 12
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Completion of at least 85% of SST treatment sessions across a 12-week period.
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up to week 12
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Patient Satisfaction With Treatment
Time Frame: End of study, week 12
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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.
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End of study, week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline
Time Frame: Baseline
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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.
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Baseline
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General Distress as Measured by the CORE-10 at 12 Weeks
Time Frame: 12 weeks
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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.
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12 weeks
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General Distress as Measured by the CORE-10 at 1-month Follow-up
Time Frame: 1-month follow-up, up to 4 months
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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.
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1-month follow-up, up to 4 months
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Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline
Time Frame: Baseline
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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.
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Baseline
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Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks
Time Frame: 12 weeks
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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.
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12 weeks
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Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up
Time Frame: 1-month follow-up, up to 4 months
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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.
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1-month follow-up, up to 4 months
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Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L)
Time Frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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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.
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Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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Number of Participants With Participant-reported Mobility Indices Available
Time Frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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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).
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Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available
Time Frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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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.
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Baseline, 12 weeks, 1 month follow-up (up to 4 months)
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Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline
Time Frame: Baseline
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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.
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Baseline
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Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline
Time Frame: Baseline
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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.
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Baseline
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Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills.
Time Frame: End of study, week 12
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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.
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End of study, week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 2, 2020
Primary Completion (Actual)
May 20, 2021
Study Completion (Actual)
June 24, 2021
Study Registration Dates
First Submitted
August 13, 2019
First Submitted That Met QC Criteria
August 13, 2019
First Posted (Actual)
August 15, 2019
Study Record Updates
Last Update Posted (Actual)
August 3, 2022
Last Update Submitted That Met QC Criteria
July 8, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00102705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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