Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer

NCT06636721 | Recruiting DMC

• 2 other identifiers: Pro001165515T32AG000029-47
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

aging; depression; anxiety; pain; dyspnea; behavioral medicine; psycho-oncology

Outcome Measures

Primary Outcomes (3)

• Feasibility as measured by number of recruited participants who enrolled

  Study feasibility will be measured by number of recruited participants who enroll.

  5 weeks

• Feasibility as measured by number of participants who completed all study activities

  Feasibility of the study will be measured by number of participants who complete all study activities.

  5 weeks

• Acceptability as measured by Study Satisfaction Questionnaire

  Acceptability of the study will be measured by the Study Satisfaction Questionnaire. This is a 15-item measure using a 5-point Likert scale (from "strongly disagree" to "strongly agree") in which a higher score indicates greater satisfaction.

  5 weeks

Secondary Outcomes (4)

• Change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)

  Baseline to 5 weeks

• Change in anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) scale

  Baseline to 5 weeks

• Change in physical pain as measured by the Brief Pain Questionnaire (BPI)

  Baseline to 5 weeks

• Change in dyspnea as measured by the Chronic Respiratory Questionnaire (CRQ)

  Baseline to 5 weeks

Study Arms (1)

Behavioral Intervention

EXPERIMENTAL

Participants will engage in a 5-session protocol, to be delivered in an individual therapy setting, via telehealth or in-person. The program will integrate aspects of Cognitive Behavioral Therapy and Acceptance and Commitment Therapy.

Behavioral: LuCA Behavioral Intervention

Interventions

LuCA Behavioral Intervention BEHAVIORAL

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.

Behavioral Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lung cancer diagnosis
• years of age or older
• Receiving active treatment at Duke University Health System
• Able to speak/read English and provide informed consent
• 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
• Provide care for older adults with lung cancer
• Able to speak/read English and provide informed consent

You may not qualify if:

• Visual or hearing impairment, cognitive impairment, or severe mental illness interfering with participation

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Depression; Anxiety Disorders; Pain; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory

Study Officials

• Rebecca A Shelby, PhD

  Duke Psychiatry & Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole A Arrato, PhD

CONTACT

919-668-8660; nicole.arrato@duke.edu

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: October 8, 2024
• First Posted: October 15, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)