Behavioral Intervention for Lung Cancer
(LuCA Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRebecca A Shelby, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Visual, hearing, cognitive, severe mental illness
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on behavioral interventions rather than medication changes.
What data supports the effectiveness of the LuCA Behavioral Intervention treatment for lung cancer?
Research shows that behavioral interventions can help manage breathlessness and improve quality of life for lung cancer patients. Additionally, psychosocial interventions, which include behavioral approaches, have been effective in reducing psychological distress and enhancing well-being in cancer patients.
12345Is the LuCA Behavioral Intervention safe for humans?
There is limited specific safety data available for the LuCA Behavioral Intervention itself, but behavioral interventions in general are monitored for safety, and no major safety concerns have been highlighted in the context of lung cancer-related interventions.
26789How is the LuCA Behavioral Intervention treatment different from other treatments for lung cancer?
The LuCA Behavioral Intervention is unique because it focuses on managing breathlessness and improving quality of life through behavioral changes, rather than using medication. This approach involves lifestyle and psychological support, which can include family involvement and community activities, making it different from traditional medical treatments.
234610Eligibility Criteria
This trial is for older adults with lung cancer. It aims to help them manage symptoms and improve well-being by addressing aging-specific concerns. Participants will include patients, caregivers, and providers who can give feedback via teleconference interviews on the assessment and intervention materials.Inclusion Criteria
I am 60 years old or older.
Patient Participants: Able to speak/read English and provide informed consent
Provider Participants: Able to speak/read English and provide informed consent
+6 more
Exclusion Criteria
I do not have any severe visual, hearing, cognitive impairments, or mental illnesses that would prevent me from participating.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Initial Interviews
Participants, caregivers, and providers participate in two individual interviews to provide feedback on the assessment and intervention materials
2-4 weeks
2 visits (virtual)
Behavioral Intervention
Participants engage in a 5-session protocol integrating Cognitive Behavioral Therapy and Acceptance and Commitment Therapy
5 weeks
5 visits (telehealth or in-person)
Follow-up
Participants are monitored for changes in depression, anxiety, pain, and dyspnea
4 weeks
Participant Groups
The LuCA Behavioral Intervention is being tested to see if it's helpful for older lung cancer patients in managing their symptoms related to aging. The study involves interviews to refine the program and a later phase where participants use the revised tools to check for improvements in mood and physical discomfort.
1Treatment groups
Experimental Treatment
Group I: Behavioral InterventionExperimental Treatment1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Health SystemDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Psychosocial challenges for patients with advanced lung cancer: interventions to improve well-being. [2020]As compared to other cancers, lung malignancies are associated with high symptom burden, poorer prognosis, and stigmatization. Such factors increase psychological distress and negatively impact quality of life. Research has documented the efficacy of psychosocial interventions to alleviate psychological distress and promote well-being among patients with cancer. This article summarizes the current literature on psychosocial interventions in lung cancer. Major types of psychosocial interventions in lung cancer include cognitive-behavioral therapies, psycho-education, mind-body, exercise, and supportive or palliative care strategies. Discussion relative to the purpose, sample, research design, outcomes, and quality of the studies is presented. Findings may be useful in clinical environments as a resource to help health providers better understand mental health treatment options and care for patients facing lung cancer. The need to direct future research toward the advancement of science and improve well-being and quality of life outcomes for patients with advanced lung cancer and their family members is discussed.
Behavioral interventions for lung cancer-related breathlessness. [2019]The purpose of this report is to present behavioral interventions to assist persons with lung cancer in the management of feelings of breathlessness and, thus, also to enhance their quality of life.
Psychosocial issues and lung cancer: a behavioral approach. [2019]To examine the psychosocial issues related to lung cancer with a specific focus on women and quality of life. To review the role of behavioral medicine as an approach to treatment, including individual, family, and group interventions.
Psychoneuroimmunology and innovative behavioral interventions in patients with leukemia. [2007]To review current research examining the effects of behavioral interventions on reducing symptom distress and improving quality of life in patients with cancer and to explore the application of behavioral interventions to patients with leukemia who are immunosuppressed by the disease or its treatment.
Enhancing behavioral change among lung cancer survivors participating in a lifestyle risk reduction intervention: a qualitative study. [2021]Early detection and improved treatment have increased lung cancer survival. Lung cancer survivors have more symptom distress and lower function compared with other cancer survivors; however, few interventions are available to improve health-related quality of life (HR-QOL). Lifestyle risk reduction interventions have improved HR-QOL in other cancer survivors. The purpose of this study was to explore lung cancer survivor perspectives on making behavioral changes in the context of a lifestyle risk reduction intervention.
Lifestyle behaviors and intervention preferences of early-stage lung cancer survivors and their family caregivers. [2021]Lung cancer (LC) is a highly prevalent disease with more survivors diagnosed and treated at earlier stages. There is a need to understand psychological and lifestyle behavior needs to design interventions for this population. Furthermore, understanding the needs and role of family caregivers, especially given the risks associated with second-hand smoke, is needed.
Analysis of Hazard Factors Affecting the Quality of Life for Lung Cancer Patients after Chemotherapy. [2023]To explore the hazard factors affecting the quality of life for patients with lung cancer after chemotherapy, so as to provide evidence-based clinical proof to improve their quality of life.
Effectiveness of smoking cessation on the high-risk population of lung cancer with early screening: a systematic review and meta-analysis of randomized controlled trials until January 2022. [2023]Lung cancer has always been the malignant tumor with the highest incidence rate. Smoking is the most important risk factor for lung cancer. Although potential positive effects of smoking cessation interventions on the high-risk population of lung cancer have been observed, evidence of its definitive effect remains uncertain. This study aimed to summarize the evidence related to the effects and safety of smoking cessation interventions for the high-risk population of lung cancer.
Data and safety monitoring in social behavioral intervention trials: the REACH II experience. [2022]Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials.
Behavior and cancer prevention. [2022]This paper reviews research on the effects of behavioral risk factors on cancer incidence, as well as behavioral interventions for cancer prevention. Risk factors discussed here--tobacco use, diet, physical activity, and obesity/energy balance--are all linked with cancer etiology, and effective behavioral interventions have been developed in all of these areas. The most effective interventions appear to incorporate various components; for example, including individual as well as family activities, and involving multiple community organizations in behavior-changing activities. Behavioral theories have guided the design of these interventions, providing support that certain influences on behavior, such as self-efficacy, problem-solving skills, and social support, are important regardless of the specific behavioral target. As illustrated by the recent lowered lung cancer incidence and mortality rates for men and women, behavior change is possible and effective in cancer prevention. Clinical guidelines have been established for behavioral aspects of treatments for smoking cessation, dietary guideline compliance, physical activity, and obesity reduction, and new tools for dissemination of effective intervention materials will be helpful in increasing their use. Documenting the cost-effectiveness of behavioral interventions, using new technology interventions, and building on translational research to tailor interventions to individuals offer considerable promise for the future.