N/A
N=30
Self-System Therapy for Older Adults With Lung Cancer
Lung Cancer Stage III · Lung Cancer Stage IV
Bottom Line
View on ClinicalTrials.gov: NCT04057196 ↗Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Aug 2022
Primary outcome: Primary: Number of Patients That Complete SST Treatment Sessions — 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Complete SST Treatment Sessions |
23 | — |
| PRIMARY Patient Satisfaction With Treatment |
30.78 | — |
| SECONDARY General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline |
14.55 | — |
| SECONDARY General Distress as Measured by the CORE-10 at 12 Weeks |
12.67 | — |
| SECONDARY General Distress as Measured by the CORE-10 at 1-month Follow-up |
12.30 | — |
| SECONDARY Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline |
9.41 | — |
| SECONDARY Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks |
6.17 | — |
| SECONDARY Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up |
6.13 | — |
| SECONDARY Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L) |
102.22; 109.12; 101.47 | — |
| SECONDARY Number of Participants With Participant-reported Mobility Indices Available |
30; 23; 21 | — |
| SECONDARY Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available |
30; 23; 21 | — |
| SECONDARY Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline |
30 | — |
| SECONDARY Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline |
30 | — |
| SECONDARY Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills. |
24 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04057196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.