Lung Cancer Stage IIISST ResilienceNCT04825912

Resilience Measurement in Older Adults With Late-Stage Lung Cancer

A study testing Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience in people with Lung Cancer Stage III and Lung Cancer Stage IV, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). 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) Resilience
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 3 May 2021to 18 Mar 2022
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 or older
English-speaking
The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at his/her 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.

United States1 site

Duke University
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer

Read the 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.

Conditions: Lung Cancer Stage III, Lung Cancer Stage IV
Being tested: Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience
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) ResilienceBehavioural
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.

Study groups in NCT04825912
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 10 weeks. Receives: Behavioral: Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience

What is being measured

The primary outcome is the main question the study is designed to answer.

Confidence in Behavior as Measured by the Cancer Behavior Inventory
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.
Measured: Baseline, 8 weeks, 10 weeks

Secondary outcomes (8)

Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)
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.
Measured: Baseline, 8 weeks, 10 weeks
Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)
The CD-RISC-25 will be used for measuring resilience. The measure consists of 25 items with a scaling of 0-4. Scores range from 0-100, with higher scores being an indicator of higher resilience.
Measured: Baseline, 8 weeks, 10 weeks
Depression as Measured by the Beck Depression Inventory (BDI-II)
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 with a total score range of 0 to 63. Higher scores indicate greater depression.
Measured: Baseline, 8 weeks, 10 weeks
Positive Affect as Measured by the PANAS (Positive and Negative Scale)
The PANAS measure will be used for rating to measure positive affect. Scores range from 10-50, with higher scores indicating higher positive affect.
Measured: Baseline, 8 weeks, 10 weeks
Negative Affect as Measured by the PANAS (Positive and Negative Scale)
The PANAS measure will be used for rating to measure negative affect. Scores range from 10-50, with higher scores indicating higher negative affect.
Measured: Baseline, 8 weeks, 10 weeks
Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)
Physical Activity will be measured using the Physical Activity Scale for the Elderly (PASE). The instrument is comprised of 12 self-reported occupational, household and leisure activities items over a one-week period. The total PASE score is computed by multiplying either the time spent in each activity (hours per week) or participation (i.e., yes/no) in an activity, by empirically derived item weights and then summing overall activities. The PASE instrument uses frequency, duration, and intensity level of activity over the previous week to assign a score. The overall PASE score ranges from 0 to 793, where a higher score indicates more physical activity.
Measured: Baseline, 8 weeks, 10 weeks
Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference)
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.
Measured: Baseline, 8 weeks, 10 weeks
Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)
The Quality-of-Life measure consists of 26 items. Scores range from 26-130, with higher scores indicating higher quality of life. The measure will be offered to assess how many total participants complete the measure in its entirety.
Measured: Baseline, 8 weeks, 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 202118 Mar 2022

First posted1 Apr 2021
Study start3 May 2021
Primary completion18 Mar 2022
Study completion18 Mar 2022

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.
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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04825912
Sponsor's protocol ID: Pro00106533
Acronym: SST Resilience
Status last verified: Jan 2024
First submitted: 29 Mar 2021
Last updated: 2 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer
ClinicalTrials.gov ID: NCT04825912
Acronym / sponsor ID: SST Resilience / Pro00106533
Conditions: Lung Cancer Stage III, Lung Cancer Stage IV
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Wake Forest University Health Sciences
Study start: 3 May 2021 (actual)
Primary completion: 18 Mar 2022 (actual)
Study completion: 18 Mar 2022 (actual)
First posted: 1 Apr 2021 (actual)
Results: Posted 2 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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) ResilienceOlder 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.

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 or older
English-speaking
The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at his/her 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) ResilienceThe 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.	Behavioural	Adults with Advanced Lung Cancer

Primary outcome

Confidence in Behavior as Measured by the Cancer Behavior Inventory
Time frame: Baseline, 8 weeks, 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.

8 secondary outcomes

Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)
Time frame: Baseline, 8 weeks, 10 weeks
Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)
Time frame: Baseline, 8 weeks, 10 weeks
Depression as Measured by the Beck Depression Inventory (BDI-II)
Time frame: Baseline, 8 weeks, 10 weeks
Positive Affect as Measured by the PANAS (Positive and Negative Scale)
Time frame: Baseline, 8 weeks, 10 weeks
Negative Affect as Measured by the PANAS (Positive and Negative Scale)
Time frame: Baseline, 8 weeks, 10 weeks
Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)
Time frame: Baseline, 8 weeks, 10 weeks
Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference)
Time frame: Baseline, 8 weeks, 10 weeks
Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)
Time frame: Baseline, 8 weeks, 10 weeks

Results and safety

Results posted to the registry on 2 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adults With Advanced Lung Cancer	18	14

Primary outcome: Confidence in Behavior as Measured by the Cancer Behavior Inventory

Time frame: Baseline, 8 weeks, 10 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Adults With Advanced Lung Cancer n = 18
Baseline	80.89 (21.13)
8 weeks	85.92 (13.97)
10 weeks	93.23 (11.19)

Population analysed: Data not collected on 5 participants at 8 weeks or at 10 weeks.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adults With Advanced Lung Cancer	0 of 18 (0%)	0 of 18 (0%)	3 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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?

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 2 Feb 2024. 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 2 Feb 2024). 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?

Confidence in Behavior as Measured by the Cancer Behavior Inventory (time frame: Baseline, 8 weeks, 10 weeks). 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 NCT04825912.

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 2 Feb 2024.