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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04825912
Collaborator
Wake Forest University Health Sciences (Other)
18
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Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer
Actual Study Start Date :
May 3, 2021
Actual Primary Completion Date :
Mar 18, 2022
Actual Study Completion Date :
Mar 18, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Behavior as measured by the Cancer Behavior Inventory [Up to 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

  1. Change in Stress as measured by the Brief COPE [Up to 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.

  2. Change in Resilience as measured by the CD-RISC-25 [Up to 10 weeks.]

    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.

  3. Change in Depression as measured by the Beck Depression Inventory (BDI-II) [Up to 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. The maximum total score is 63. Higher scores indicate greater depression.

  4. Change in Positive and Negative Affect as measured by the PANAS [Up to 10 weeks.]

    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.

  5. Change in Physical Activity as measured by the Physical Activity Scale for the Elderly [Up to 10 weeks]

    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.

  6. Change in Pain Interference as measured by the PROMIS PAI [Up to 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.

  7. Change in Quality of Life as measured by the QUALE [Up to 10 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University
  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Katherine Ramos, Ph.D., Duke University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04825912
Other Study ID Numbers:
  • Pro00106533
First Posted:
Apr 1, 2021
Last Update Posted:
Apr 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022