Clinical trial NCT06636721: Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Official title: Lung Cancer and Aging (LuCA): Intervention Development for Addressing Aging-specific Concerns in Older Adults With Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: aging
depression
anxiety
pain
dyspnea
behavioral medicine
psycho-oncology
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-15
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Aim 1. The investigators will first develop a brief geriatric assessment, designed to address the specific needs of older adults with lung cancer. As a foundation, the investigators will collect existing, empirically supported geriatric assessment tools, such as the Senior Adult Oncology Program (SAOP) assessment and the Geriatric 8 (G8), and the Triage Risk Screening Tool (TRST). The investigators will combine these tools such that all relevant domains are included in the aggregated assessment. The study team will then collaboratively add further items into the assessment (as related to difficulties commonly faced by older adults with lung cancer) and remove excess or irrelevant items.

The study team will then develop the initial prototype of a need-based behavioral intervention protocol to address aging-specific concerns and multimorbidity in older adults with lung cancer. The behavioral intervention will build upon and extend a previously tested intervention, which demonstrated benefits for reducing depressive and anxiety symptoms in older adults with lung cancer. The intervention will be a 5-session protocol, to be delivered to patients in an individual therapy setting, via telehealth or in-person. The program 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.

Aim 2. The investigators will then conduct interviews with lung cancer patients (N=12), provider stakeholders (N=12), and caregivers (N=6) in order to obtain feedback on the proposed assessment and intervention. Caregiver participants will be either a) caregivers for lung cancer patients participating in interviews for this study, or b) caregivers for other patients with lung cancer. Each interview will be 30-45 minutes in length.

All patient, caregiver, and provider interview sessions will be recorded and transcribed verbatim. During interview sessions, the participant will be provided with the current version of the geriatric assessment and behavioral intervention. A semi-structured interview script will be utilized to obtain feedback on the strengths and weaknesses of the materials, thoughts on topics to add or remove, and amendments to any wording or structural details. Data from the initial interviews will allow the investigators to refine the assessment, referral resources, and intervention content so that it best meets the needs of this patient population.

All patients, caregivers, and provider stakeholders will be invited to complete a second interview to provide feedback on the revised materials. Thus, participants will be recruited to participate in 2 interviews - one for the initial set of materials, and one for the revised set. Because all participation is voluntary, participants can choose to opt out of any portion. If the investigators are unable to obtain adequate response rates for the second interview, they will recruit new participants meeting eligibility criteria to complete interviews surrounding the revised material.

Aim 3. The investigators will then conduct a preliminary study to evaluate the feasibility and acceptability of the revised geriatric assessment and behavioral intervention protocol. N=16 older adults with lung cancer will be recruited to complete the geriatric assessment and 5-session intervention. The assessment will be completed on paper in the clinic or digitally via RedCap survey sent via email, based on participant preference. The intervention sessions will be conducted via telehealth. Sessions will occur once per week for 5 weeks, and will last approximately one hour each. Sessions will be video-recorded and transcribed verbatim.

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

Primary outcomes:
measure: Feasibility as measured by number of recruited participants who enrolled
timeFrame: 5 weeks
measure: Feasibility as measured by number of participants who completed all study activities
timeFrame: 5 weeks
measure: Acceptability as measured by Study Satisfaction Questionnaire
timeFrame: 5 weeks
Secondary outcomes:
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to 5 weeks
measure: Change in anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) scale
timeFrame: Baseline to 5 weeks
measure: Change in physical pain as measured by the Brief Pain Questionnaire (BPI)
timeFrame: Baseline to 5 weeks
measure: Change in dyspnea as measured by the Chronic Respiratory Questionnaire (CRQ)
timeFrame: Baseline to 5 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Psychiatry & Behavioral Sciences
name: Rebecca A Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
References: