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

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

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

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.
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
Time Frame: 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.
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)
Time Frame: 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.
Baseline, 8 weeks, 10 weeks
Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)
Time Frame: 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.
Baseline, 8 weeks, 10 weeks
Depression as Measured by the Beck Depression Inventory (BDI-II)
Time Frame: 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.
Baseline, 8 weeks, 10 weeks
Positive Affect as Measured by the PANAS (Positive and Negative Scale)
Time Frame: 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.
Baseline, 8 weeks, 10 weeks
Negative Affect as Measured by the PANAS (Positive and Negative Scale)
Time Frame: 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.
Baseline, 8 weeks, 10 weeks
Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)
Time Frame: 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.
Baseline, 8 weeks, 10 weeks
Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference)
Time Frame: 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.
Baseline, 8 weeks, 10 weeks
Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)
Time Frame: 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.
Baseline, 8 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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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