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Trial Title:
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
NCT ID:
NCT06636721
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
aging
depression
anxiety
pain
dyspnea
behavioral medicine
psycho-oncology
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
LuCA Behavioral Intervention
Description:
The intervention will integrate aspects of Cognitive Behavioral Therapy (identifying and
challenging automatic thoughts, engaging in behavioral activation) and Acceptance and
Commitment Therapy (integrating one's values, distancing skills). The intervention will
include skills such as problem-solving, communicating with close others and the medical
team, and breathing techniques to improve shortness of breath related to lung cancer.
Arm group label:
Behavioral Intervention
Summary:
The purpose of this study is to develop a brief assessment and need-based behavioral
intervention for addressing aging-specific concerns in older adults with lung cancer. The
long-term goals of this research include identifying the unique concerns of these
patients, providing patients with behavioral skills to address their symptom management
needs, and enhancing patient engagement with healthcare specialties targeting
aging-specific concerns.
In the first phase of this study, participants (12 patients with lung cancer, 6
caregivers, 12 providers) will be asked to participate in two individual interviews (each
30-45 minutes in length) via teleconference. During the first interview, participants
will be asked to provide feedback on the current version of the assessment and behavioral
intervention. Participants will be asked to describe strengths and weaknesses of the
materials, topics to add or remove, and any other suggested changes. After the research
team has made changes to the materials, participants will be invited to complete a second
interview to provide feedback on the updated materials.
In the second phase of the study, 16 older adults with lung cancer will complete the
revised assessment and participate in the behavioral intervention, in order to a)
evaluate the feasibility and acceptability of the program and b) measure change in
depression, anxiety, pain, and dyspnea.
Criteria for eligibility:
Criteria:
Inclusion Criteria for Patient Participants:
- Lung cancer diagnosis
- 60 years of age or older
- Receiving active treatment at Duke University Health System
- Able to speak/read English and provide informed consent
Inclusion Criteria for Caregiver Participants:
- Caregiver for a patient with lung cancer participating in this study
- Caregiver for other patient with lung cancer
- Able to speak/read English and provide informed consent
Inclusion Criteria for Provider Participants:
- Provide care for older adults with lung cancer
- Able to speak/read English and provide informed consent
Exclusion Criteria for all:
- Visual or hearing impairment, cognitive impairment, or severe mental illness
interfering with participation
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Duke University Health System
Address:
City:
Durham
Zip:
27705
Country:
United States
Contact:
Last name:
Nicole A Arrato, PhD
Phone:
919-668-8660
Email:
nicole.arrato@duke.edu
Investigator:
Last name:
Rebecca A Shelby, PhD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
National Institute on Aging (NIA)
Agency class:
NIH
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636721