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

Primary Purpose

Lung Cancer Stage III, Lung Cancer Stage IV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer Stage III

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adults with Advanced Lung Cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

Change 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.

Secondary Outcome Measures

Change in Stress as measured by the Brief COPE
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.
Change in Resilience as measured by the CD-RISC-25
The Connor-Davidson Resilience Scale (CD-RISC-10) will be used for measuring resilience. The measure consists of 25 items. Scores range from 0-40, with higher scores being an indicator of high resilience.
Change in 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. The maximum total score is 63. Higher scores indicate greater depression.
Change in Positive and Negative Affect as measured by the PANAS
The Positive and Negative Scale (PANAS) measure will be used for rating to measure both positive and negative affect. The measure consists of two 10-item scales. Scores range from 10-50, with higher scores indicating higher positive and negative affect.
Change in Physical Activity as measured by the 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 self-reported occupational, household and leisure activities items over a one-week period. PASE scores are calculated from weights and frequency values for each of 12 types of activity.
Change in Pain Interference as measured by the PROMIS PAI
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.
Change in Quality of Life as measured by the QUALE
The Quality-of-Life measure will be used for rating quality of life. The measure consists of 26 items. Scores range from 26-130, with higher scores indicating higher quality of life.

Full Information

First Posted
March 29, 2021
Last Updated
April 22, 2022
Sponsor
Duke University
Collaborators
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04825912
Brief Title
Resilience Measurement in Older Adults With Late-Stage Lung Cancer
Acronym
SST Resilience
Official Title
Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Stage III, Lung Cancer Stage IV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adults with Advanced Lung Cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Behavior as measured by the Cancer Behavior Inventory
Description
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.
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
Change in Stress as measured by the Brief COPE
Description
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.
Time Frame
Up to 10 weeks
Title
Change in Resilience as measured by the CD-RISC-25
Description
The Connor-Davidson Resilience Scale (CD-RISC-10) will be used for measuring resilience. The measure consists of 25 items. Scores range from 0-40, with higher scores being an indicator of high resilience.
Time Frame
Up to 10 weeks.
Title
Change in Depression as measured by the Beck Depression Inventory (BDI-II)
Description
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. The maximum total score is 63. Higher scores indicate greater depression.
Time Frame
Up to 10 weeks.
Title
Change in Positive and Negative Affect as measured by the PANAS
Description
The Positive and Negative Scale (PANAS) measure will be used for rating to measure both positive and negative affect. The measure consists of two 10-item scales. Scores range from 10-50, with higher scores indicating higher positive and negative affect.
Time Frame
Up to 10 weeks.
Title
Change in Physical Activity as measured by the Physical Activity Scale for the Elderly
Description
Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE)The instrument is comprised of self-reported occupational, household and leisure activities items over a one-week period. PASE scores are calculated from weights and frequency values for each of 12 types of activity.
Time Frame
Up to 10 weeks
Title
Change in Pain Interference as measured by the PROMIS PAI
Description
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.
Time Frame
Up to 10 weeks
Title
Change in Quality of Life as measured by the QUALE
Description
The Quality-of-Life measure will be used for rating quality of life. The measure consists of 26 items. Scores range from 26-130, with higher scores indicating higher quality of life.
Time Frame
Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Ramos, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Resilience Measurement in Older Adults With Late-Stage Lung Cancer

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