Lung Cancer Stage IIINCT04057196
Self-System Therapy for Older Adults With Lung Cancer
A study testing Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) in people with Lung Cancer Stage III and Lung Cancer Stage IV, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Lung Cancer Stage III, Lung Cancer Stage IV
- What is being tested?
- Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2020to 24 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- English-speaking
- The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at her/his home.
Who cannot join
- Unable to provide informed consent
- Visual or hearing impairments that preclude participation
- Serious mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-System Therapy for Older Adults With Advanced Lung Cancer (SST-LC)
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).
Read the 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.
- Conditions
- Lung Cancer Stage III, Lung Cancer Stage IV
- Being tested
- Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients That Complete SST Treatment Sessions
Completion of at least 85% of SST treatment sessions across a 12-week period.
Measured: 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.
Measured: End of study, week 12
Secondary outcomes (12)
General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline
The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.
Measured: Baseline
General Distress as Measured by the CORE-10 at 12 Weeks
The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.
Measured: 12 weeks
General Distress as Measured by the CORE-10 at 1-month Follow-up
The CORE-10 measure will be used for rating general distress. The measure comprises ten questions about how participants have been feeling over the past week. Scores range from 0-40, with higher scores indicating greater distress.
Measured: 1-month follow-up, up to 4 months
Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline
Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II 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 total score ranges from 0 to 63, where higher scores indicate greater depression.
Measured: Baseline
Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks
Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II 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 total score ranges from 0 to 63, where higher scores indicate greater depression.
Measured: 12 weeks
Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up
Depression will be measured using the Beck Depression Inventory (BDI-II). The measure has 21 items. The BDI-II 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 total score ranges from 0 to 63, where higher scores indicate greater depression.
Measured: 1-month follow-up, up to 4 months
Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L)
Functioning will be measured using the Functional Assessment of Cancer Therapy- Lung (FACT-L). The FACT-L is a 36-item measure, each item with a five-point scale from 0 (not at all) to 4 (very much), measuring overall quality of life (QOL) across five dimensions that are summed together to derive a total score. The total score range is from 0-136. The higher the score, the better the QOL.
Measured: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Number of Participants With Participant-reported Mobility Indices Available
Mobility indices will include participant report of difficulty walking across a room without help from another person or equipment (none, a little vs some, a lot, unable), difficulty walking two to three blocks without help from another person or equipment (none, a little vs some, a lot, unable), and use of assistive device (yes vs no).
Measured: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available
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.
Measured: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline
Self-Discrepancy will be measured using the Computerized Selves Questionnaire (CSQ). The CSQ is a computer-based version of the original self-discrepancy questionnaire used by Higgins and colleagues (1986) in which a person is asked to produce a list of eight personal attributes that s/he would ideally like to possess and eight attributes s/he feels s/he ought to possess. To score, qualities in the actual self column are compared with those in the ought self column.
Measured: Baseline
Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline
Self-Regulatory Orientation will be measured using the Regulatory Focus Questionnaire (RFQ).The measure has 11 items using 5-point scales, along two sub scales measuring the extent to which an individual believes s/he has been successful in attaining promotion or prevention goals. Six questions quantify Promotion and five questions quantify Prevention the promotion sums must be divided by 6, and the prevention sums must be divided by 5 in order to place scores for both orientations on the same 1-5 scale.
Measured: Baseline
Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills.
Trained raters will listen to audio recordings of treatment sessions and use a pre-defined checklist of session content and strategies of the treatment to indicate if session coping skills were taught (yes/no) coded as 1 for yes and 0 for no. Higher scores indicate greater session fidelity.
Measured: End of study, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start2 Apr 2020
- Primary completion20 May 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Katherine Ramos, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057196
- Sponsor's protocol ID
- Pro00102705
- Status last verified
- Jul 2022
- First submitted
- 13 Aug 2019
- Last updated
- 3 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28216800Waters 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.
PubMed 26079438Ramos 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.
PubMed 40940906
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-System Therapy for Older Adults With Advanced Lung Cancer (SST-LC)
- ClinicalTrials.gov ID
- NCT04057196
- Acronym / sponsor ID
- Pro00102705
- Conditions
- Lung Cancer Stage III, Lung Cancer Stage IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Posted 3 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Advanced Lung Cancer | Experimental | Behavioral: Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years
- English-speaking
- The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at her/his home.
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Visual or hearing impairments that preclude participation
- Serious mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)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. | Behavioural | Adults with Advanced Lung Cancer |
Primary outcome
Number of Patients That Complete SST Treatment Sessions
Time frame: up to week 12
Completion of at least 85% of SST treatment sessions across a 12-week period.
Patient Satisfaction With Treatment
Time frame: End of study, week 12
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.
12 secondary outcomes
General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline
Time frame: Baseline
General Distress as Measured by the CORE-10 at 12 Weeks
Time frame: 12 weeks
General Distress as Measured by the CORE-10 at 1-month Follow-up
Time frame: 1-month follow-up, up to 4 months
Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline
Time frame: Baseline
Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks
Time frame: 12 weeks
Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up
Time frame: 1-month follow-up, up to 4 months
Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L)
Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Number of Participants With Participant-reported Mobility Indices Available
Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available
Time frame: Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline
Time frame: Baseline
Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline
Time frame: Baseline
Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills.
Time frame: End of study, week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28216800Strauman 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.
- Background: PubMed 26079438Waters 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.
- Derived from this study: PubMed 40940906Ramos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Ramos, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) in people with Lung Cancer Stage III and Lung Cancer Stage IV, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients That Complete SST Treatment Sessions (time frame: up to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04057196, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.