Self-System Therapy for Older Adults With Lung Cancer

NCT04057196 | Completed Results DMC

• 1 other identifier: Pro00102705
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to use Self-system therapy (SST), to treat depression and lung-cancer-related distress in older adults (65 years and older).

Conditions

Lung Cancer Stage III; Lung Cancer Stage IV

Outcome Measures

Primary Outcomes (2)

• Number of Patients That Complete SST Treatment Sessions

  Completion of at least 85% of SST treatment sessions across a 12-week period.

  up to week 12

• Patient Satisfaction With Treatment

  The Client Satisfaction Questionnaire (CSQ-8), which assesses treatment credibility (pre-treatment) and effectiveness of/satisfaction with services (post-treatment). An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores therefore range from 8 to 32, with higher values indicating higher satisfaction.

  End of study, week 12

Secondary Outcomes (12)

• General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline

  Baseline

• General Distress as Measured by the CORE-10 at 12 Weeks

  12 weeks

• General Distress as Measured by the CORE-10 at 1-month Follow-up

  1-month follow-up, up to 4 months

• Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline

  Baseline

• Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks

  12 weeks

Study Arms (1)

Adults with Advanced Lung Cancer

EXPERIMENTAL

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 12 weeks.

Behavioral: Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)

Interventions

Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) BEHAVIORAL

The SST-LC is a brief structured intervention deliverable by video conference. The new SST-LC 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.

Adults with Advanced Lung Cancer

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• English-speaking
• The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at her/his home.

You may not qualify if:

• Unable to provide informed consent
• Visual or hearing impairments that preclude participation
• Serious mental illness

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (3)

• Strauman TJ, Eddington KM. Treatment of Depression From a Self-Regulation Perspective: Basic Concepts and Applied Strategies in Self-System Therapy. Cognit Ther Res. 2017 Feb;41(1):1-15. doi: 10.1007/s10608-016-9801-1. Epub 2016 Aug 29.

  PMID: 28216800 BACKGROUND

• Waters SJ, Strauman TJ, McKee DC, Campbell LC, Shelby RA, Dixon KE, Fras AM, Keefe FJ. Self-system therapy for distress associated with persistent low back pain: A randomized clinical trial. Psychother Res. 2016 Jul;26(4):472-83. doi: 10.1080/10503307.2015.1040485. Epub 2015 Jun 16.

  PMID: 26079438 BACKGROUND

• Ramos K, Ayaz A, Riley J, Faircloth K, Porter LS, Strauman TJ. Adaptation and Implementation of Self-System Therapy for Older Adults with Advanced Lung Cancer: Pilot Trial Results. Cancers (Basel). 2025 Aug 28;17(17):2809. doi: 10.3390/cancers17172809.

  PMID: 40940906 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Aging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Results Point of Contact

• Title: Katherine Ramos, Ph.D.
• Organization: Duke University

Katherine.Ramos@duke.edu

919-416-3434

Study Officials

• Katherine Ramos, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: April 2, 2020
• Primary Completion: May 20, 2021
• Study Completion: June 24, 2021
• Last Updated: August 3, 2022
• Results First Posted: August 3, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)