Resilience Measurement in Older Adults With Late-Stage Lung Cancer

Lung Cancer Stage IV Clinical Trial

— SST Resilience  

Official title:

Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825912
• Other study ID #: Pro00106533
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: March 18, 2022

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

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) Resilience
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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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