- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04825912
Resilience Measurement in Older Adults With Late-Stage Lung Cancer (SST Resilience)
January 31, 2024 updated by: Duke University
Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer
The purpose of this study to test measures of physical and psychological resilience while using 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 the feasibility of delivering measures of psychological and physical resilience while delivering the SST intervention.
The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall physical functioning in older adults with advanced lung cancer.
Study Type
Interventional
Enrollment (Actual)
18
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
Description
Inclusion Criteria:
- Age 65 or older
- English-speaking
- The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at his/her 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 10 weeks.
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The SST-LC is a brief structured intervention deliverable by video conference.
The SST-LC Resilience 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.
The focus will be to test measures of resilience during the intervention period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confidence in Behavior as Measured by the Cancer Behavior Inventory
Time Frame: Baseline, 8 weeks, 10 weeks
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The Cancer Behavior Inventory measure will be used for rating confidence in behavior.
The measure consist of 12 items.
Scores range from 12-108 with higher scores indicating greater confidence.
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Baseline, 8 weeks, 10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)
Time Frame: Baseline, 8 weeks, 10 weeks
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The Brief COPE measure will be used for rating coping skills related to stress.
The measure consists of 28 items.
Scores range from 28-112 with higher scores indicating lower stress.
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Baseline, 8 weeks, 10 weeks
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Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)
Time Frame: Baseline, 8 weeks, 10 weeks
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The CD-RISC-25 will be used for measuring resilience.
The measure consists of 25 items with a scaling of 0-4.
Scores range from 0-100, with higher scores being an indicator of higher resilience.
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Baseline, 8 weeks, 10 weeks
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Depression as Measured by the Beck Depression Inventory (BDI-II)
Time Frame: Baseline, 8 weeks, 10 weeks
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Depression will be measured using the Beck Depression Inventory (BDI-II).
The measure consists of 21 items.
The BDIII is scored by summing the ratings for the 21 items.
Each item is rated on a 4-point scale ranging from 0 to 3 with a total score range of 0 to 63.
Higher scores indicate greater depression.
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Baseline, 8 weeks, 10 weeks
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Positive Affect as Measured by the PANAS (Positive and Negative Scale)
Time Frame: Baseline, 8 weeks, 10 weeks
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The PANAS measure will be used for rating to measure positive affect.
Scores range from 10-50, with higher scores indicating higher positive affect.
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Baseline, 8 weeks, 10 weeks
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Negative Affect as Measured by the PANAS (Positive and Negative Scale)
Time Frame: Baseline, 8 weeks, 10 weeks
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The PANAS measure will be used for rating to measure negative affect.
Scores range from 10-50, with higher scores indicating higher negative affect.
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Baseline, 8 weeks, 10 weeks
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Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)
Time Frame: Baseline, 8 weeks, 10 weeks
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Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE).
The instrument is comprised of 12 self-reported occupational, household and leisure activities items over a one-week period.
The total PASE score is computed by multiplying either the time spent in each activity (hours per week) or participation (i.e., yes/no) in an activity, by empirically derived item weights and then summing overall activities.
The PASE instrument uses frequency, duration, and intensity level of activity over the previous week to assign a score.
The overall PASE score ranges from 0 to 793, where a higher score indicates more physical activity.
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Baseline, 8 weeks, 10 weeks
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Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference)
Time Frame: Baseline, 8 weeks, 10 weeks
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The Pain Interference PROMIS Scale measure will be used for rating pain interference in daily living.
The measure consists of 6 items.
Scores range from 6-30, with higher scores indicating higher pain interference.
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Baseline, 8 weeks, 10 weeks
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Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)
Time Frame: Baseline, 8 weeks, 10 weeks
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The Quality-of-Life measure consists of 26 items.
Scores range from 26-130, with higher scores indicating higher quality of life.
The measure will be offered to assess how many total participants complete the measure in its entirety.
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Baseline, 8 weeks, 10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine Ramos, Ph.D., Duke University
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)
May 3, 2021
Primary Completion (Actual)
March 18, 2022
Study Completion (Actual)
March 18, 2022
Study Registration Dates
First Submitted
March 29, 2021
First Submitted That Met QC Criteria
March 29, 2021
First Posted (Actual)
April 1, 2021
Study Record Updates
Last Update Posted (Estimated)
February 2, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00106533
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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