Resilience Measurement in Older Adults With Late-Stage Lung Cancer (SST Resilience)

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: Lung Cancer Stage III; Lung Cancer Stage IV
• Intervention / Treatment: Behavioral: Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience

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

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Katherine Ramos, Ph.D., Duke University

Study record dates

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: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• 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