NCT04825912

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 2, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

March 29, 2021

Results QC Date

February 24, 2023

Last Update Submit

January 31, 2024

Conditions

Lung Cancer Stage IIILung Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 8 weeks, 10 weeks

Secondary Outcomes (8)

  • Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)

    Baseline, 8 weeks, 10 weeks

  • Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)

    Baseline, 8 weeks, 10 weeks

  • Depression as Measured by the Beck Depression Inventory (BDI-II)

    Baseline, 8 weeks, 10 weeks

  • Positive Affect as Measured by the PANAS (Positive and Negative Scale)

    Baseline, 8 weeks, 10 weeks

  • Negative Affect as Measured by the PANAS (Positive and Negative Scale)

    Baseline, 8 weeks, 10 weeks

  • +3 more secondary outcomes

Study Arms (1)

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.

Behavioral: Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience

Interventions

Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) ResilienceBEHAVIORAL

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.

Adults with Advanced Lung Cancer

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Aging

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Results Point of Contact

Title
Katherine Ramos, Ph.D.
Organization
Duke University
Katherine.Ramos@duke.edu
919-416-3434

Study Officials

  • Katherine Ramos, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

May 3, 2021

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

February 2, 2024

Results First Posted

February 2, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)