Resilience Measurement in Older Adults With Late-Stage 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) Resilience

• Registration Number: NCT04825912
• Lead Sponsor: Duke University

Brief Summary

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-05-03
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-18
• Results First Submitted: 2023-02-24
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Results First Posted: 2024-02-02
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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) Resilience	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.

Primary Outcome Measures

Name	Time	Method
Confidence in Behavior as Measured by the Cancer Behavior Inventory	Baseline, 8 weeks, 10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)	Baseline, 8 weeks, 10 weeks	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.
Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference)	Baseline, 8 weeks, 10 weeks	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.
Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)	Baseline, 8 weeks, 10 weeks	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.
Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)	Baseline, 8 weeks, 10 weeks	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.
Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)	Baseline, 8 weeks, 10 weeks	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.
Depression as Measured by the Beck Depression Inventory (BDI-II)	Baseline, 8 weeks, 10 weeks	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.
Positive Affect as Measured by the PANAS (Positive and Negative Scale)	Baseline, 8 weeks, 10 weeks	The PANAS measure will be used for rating to measure positive affect. Scores range from 10-50, with higher scores indicating higher positive affect.
Negative Affect as Measured by the PANAS (Positive and Negative Scale)	Baseline, 8 weeks, 10 weeks	The PANAS measure will be used for rating to measure negative affect. Scores range from 10-50, with higher scores indicating higher negative affect.

Trial Locations

Locations (1)

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