Clinical trial NCT04057196: Self-System Therapy for Older Adults With Lung Cancer
Official title: Self-System Therapy for Older Adults With Advanced Lung Cancer (SST-LC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Stage III
Lung Cancer Stage IV
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: The investigator will examine whether delivering the SST intervention will be both feasible and acceptable to study participants. The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall functioning in older adults with advanced lung cancer.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Patients That Complete SST Treatment Sessions
timeFrame: up to week 12
measure: Patient Satisfaction With Treatment
timeFrame: End of study, week 12
Secondary outcomes:
measure: General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline
timeFrame: Baseline
measure: General Distress as Measured by the CORE-10 at 12 Weeks
timeFrame: 12 weeks
measure: General Distress as Measured by the CORE-10 at 1-month Follow-up
timeFrame: 1-month follow-up, up to 4 months
measure: Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline
timeFrame: Baseline
measure: Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks
timeFrame: 12 weeks
measure: Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up
timeFrame: 1-month follow-up, up to 4 months
measure: Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L)
timeFrame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
measure: Number of Participants With Participant-reported Mobility Indices Available
timeFrame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
measure: Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available
timeFrame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
measure: Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline
timeFrame: Baseline
measure: Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline
timeFrame: Baseline
measure: Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills.
timeFrame: End of study, week 12
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Katherine Ramos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.