search
Back to results

Self-System Therapy for Older Adults With Lung Cancer

Primary Purpose

Lung Cancer Stage III, Lung Cancer Stage IV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer Stage III

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adults with Advanced Lung Cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Patients That Complete SST Treatment Sessions
Completion of at least 85% of SST treatment sessions across a 12-week period.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.

Full Information

First Posted
August 13, 2019
Last Updated
July 8, 2022
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04057196
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
June 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Stage III, Lung Cancer Stage IV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adults with Advanced Lung Cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients That Complete SST Treatment Sessions
Description
Completion of at least 85% of SST treatment sessions across a 12-week period.
Time Frame
up to week 12
Title
Patient Satisfaction With Treatment
Description
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.
Time Frame
End of study, week 12
Secondary Outcome Measure Information:
Title
General Distress as Measured by the CORE-10 (Clinical Outcomes in Routine Evaluation 10) at Baseline
Description
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.
Time Frame
Baseline
Title
General Distress as Measured by the CORE-10 at 12 Weeks
Description
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.
Time Frame
12 weeks
Title
General Distress as Measured by the CORE-10 at 1-month Follow-up
Description
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.
Time Frame
1-month follow-up, up to 4 months
Title
Depression as Measured by the Beck Depression Inventory (BDI-II) at Baseline
Description
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.
Time Frame
Baseline
Title
Depression as Measured by the Beck Depression Inventory (BDI-II) at 12 Weeks
Description
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.
Time Frame
12 weeks
Title
Depression as Measured by the Beck Depression Inventory (BDI-II) at 1-month Follow-up
Description
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.
Time Frame
1-month follow-up, up to 4 months
Title
Functioning as Measured by the Functional Assessment of Cancer Therapy- Lung (FACT-L)
Description
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.
Time Frame
Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Title
Number of Participants With Participant-reported Mobility Indices Available
Description
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).
Time Frame
Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Title
Number of Participants With Physical Activity Scale for the Elderly (PASE) Scores Available
Description
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.
Time Frame
Baseline, 12 weeks, 1 month follow-up (up to 4 months)
Title
Number of Participants With Computerized Selves Questionnaire (CSQ) Responses Available at Baseline
Description
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.
Time Frame
Baseline
Title
Number of Participants With Regulatory Focus Questionnaire (RFQ) Responses Available at Baseline
Description
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.
Time Frame
Baseline
Title
Treatment Session Fidelity as Measured by Number of Participants Who Were Taught All Skills.
Description
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.
Time Frame
End of study, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Ramos, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28216800
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.
Results Reference
background
PubMed Identifier
26079438
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.
Results Reference
background

Learn more about this trial

Self-System Therapy for Older Adults With Lung Cancer

We'll reach out to this number within 24 hrs