Behavioral Intervention for Lung Cancer

(LuCA Trial)

Overseen By Nicole A Arrato, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Visual, hearing, cognitive, severe mental illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop the LuCA Behavioral Intervention, a program designed to help older adults with lung cancer manage symptoms and concerns related to aging. Initially, the study will gather feedback on the program from patients, caregivers, and healthcare providers. It will then assess the program's effectiveness in reducing depression, anxiety, pain, and breathing difficulties. The program targets individuals aged 60 or older with lung cancer who are currently receiving treatment at Duke University Health System. As an unphased trial, this study provides participants the opportunity to contribute to innovative research that could enhance symptom management for older adults with lung cancer.

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 prior data suggests that this behavioral intervention is safe for older adults with lung cancer?

Research has shown that the LuCA Behavioral Intervention is a safe and supportive program for older adults with lung cancer. Although specific safety data for this exact program is limited, similar therapies such as Cognitive Behavioral Therapy and Acceptance and Commitment Therapy, which are included in this program, are generally well-tolerated. These widely used therapies help manage symptoms like anxiety and depression without significant risk. Participants in studies of similar programs reported overall improvement. As a behavioral program, it involves talking and activities rather than medications, often making it safer for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LuCA Behavioral Intervention for lung cancer because it integrates Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) into a structured program. Unlike traditional treatments that focus on medical or surgical approaches, this intervention emphasizes psychological support, aiming to improve mental health and quality of life. The flexibility of being delivered via telehealth or in-person makes it more accessible, addressing barriers like travel and time, which are often challenges for patients undergoing cancer treatment.

What evidence suggests that this behavioral intervention is effective for lung cancer?

Research has shown that certain behavioral techniques can improve the quality of life for lung cancer patients by managing symptoms like difficulty breathing. These techniques often include methods from Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT), which have effectively reduced anxiety and depression. This trial will evaluate the LuCA Behavioral Intervention, which integrates these methods in a 5-session protocol. Although this study focuses on older adults with lung cancer, past participants have demonstrated improvements in managing their symptoms and becoming more involved in their healthcare. This suggests that the LuCA Behavioral Intervention could effectively address concerns specific to aging in these patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Rebecca A Shelby, PhD

Principal Investigator

Duke Psychiatry & Behavioral Sciences

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I do not have any severe visual, hearing, cognitive impairments, or mental illnesses that would prevent me from participating.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• LuCA Behavioral Intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Behavioral Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Behavioral interventions like relaxation training and guided imagery can effectively reduce pain, anxiety, and side effects from chemotherapy in cancer patients, potentially improving their immune function.

Implementing a long-term, multicomponent program of these interventions may offer the most benefits, but even simple relaxation techniques are easy to learn and can be integrated into daily life, making them accessible for patients with leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoneuroimmunology and innovative behavioral interventions in patients with leukemia. Caudell, KA.[2007]

Psychosocial interventions, such as cognitive-behavioral therapies and mind-body strategies, have been shown to effectively reduce psychological distress and improve quality of life for lung cancer patients, who often face significant emotional challenges due to their diagnosis.

The article emphasizes the importance of these interventions in clinical settings, suggesting that healthcare providers should be aware of and utilize these mental health treatment options to support lung cancer patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial challenges for patients with advanced lung cancer: interventions to improve well-being. Lehto, RH.[2020]

The REACH II program, a multi-site trial focused on caregivers of Alzheimer's patients, highlighted the need for tailored safety monitoring and adverse event reporting protocols in psychosocial and behavioral intervention studies, as existing guidelines primarily address medical interventions.

The study identified unique challenges in defining and classifying adverse events, as well as establishing resolution criteria, emphasizing the variability in safety monitoring practices across psychosocial trials and the necessity for standardized protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Czaja, SJ., Schulz, R., Belle, SH., et al.[2022]

Smoking cessation interventions, particularly individualized programs, significantly improve the likelihood of smoking abstinence in high-risk lung cancer populations compared to standard care, with a relative risk of 1.46 for 7-day-point prevalence.

E-cigarettes were found to be the most effective smoking cessation method, showing a significant increase in continuous smoking abstinence compared to standard care, with a relative risk of 1.51 within a 1-6 month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Huang, S., Tang, O., Zheng, X., et al.[2023]

Lung cancer survivors reported that their diagnosis motivated them to make positive lifestyle changes, and they found coaching helpful in interpreting symptoms and setting achievable goals for behavior change.

The study highlighted the importance of social support in maintaining these changes, but also noted that some survivors struggled with the recommended physical activity goals, indicating a need for more personalized activity plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing behavioral change among lung cancer survivors participating in a lifestyle risk reduction intervention: a qualitative study. Somayaji, D., Blok, AC., Hayman, LL., et al.[2021]

Behavioral risk factors like tobacco use, diet, physical activity, and obesity are linked to cancer, but effective interventions can significantly reduce cancer incidence, as seen in the recent decline in lung cancer rates.

Successful cancer prevention strategies incorporate multiple components, such as individual and family activities, community involvement, and are guided by behavioral theories that emphasize self-efficacy and social support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior and cancer prevention. Gotay, CC.[2022]

Behavioral interventions, such as breathing exercises that focus on diaphragm use and altering breathing rhythms, can significantly help lung cancer patients manage feelings of breathlessness and improve their quality of life.

Oncology professionals should incorporate these psychosocially oriented strategies alongside medical treatments to effectively address the debilitating symptom of breathlessness in lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for lung cancer-related breathlessness. Gallo-Silver, L., Pollack, B.[2019]

A study involving 31 early-stage lung cancer survivors and 22 caregivers revealed that while survivors had low psychological distress and smoking rates, 79% were sedentary and not meeting physical activity guidelines, indicating a need for targeted interventions.

Both survivors and caregivers showed interest in home-based physical activity interventions, with caregivers preferring a joint approach, suggesting that dyadic interventions could also help caregivers quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle behaviors and intervention preferences of early-stage lung cancer survivors and their family caregivers. Roddy, MK., Flores, RM., Burt, B., et al.[2021]

Behavioral interventions, when combined with medical treatment for lung cancer, can significantly alleviate symptoms such as nausea, vomiting, pain, and anxiety, thereby improving patients' quality of life.

These mind/body approaches not only reduce emotional distress but also enhance coping mechanisms, promote a sense of control, and foster hopefulness among patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial issues and lung cancer: a behavioral approach. Ryan, LS.[2019]

A study of 74 lung cancer patients undergoing chemotherapy revealed an average quality of life score of 94.53, indicating a significant impact of treatment on their well-being.

Factors such as age, education level, marital status, type of lung cancer, family income, and presence of metastasis were identified as key influences on the quality of life, suggesting that personalized care strategies are essential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Hazard Factors Affecting the Quality of Life for Lung Cancer Patients after Chemotherapy. Wen, L., Liao, X., Cao, Y., et al.[2023]

Citations

1.

withpower.com

withpower.com/trial/behavioral-intervention-for-lung-cancer-a4e48

Behavioral Intervention for Lung Cancer (LuCA Trial)

Research shows that behavioral interventions can help manage breathlessness and improve quality of life for lung cancer patients. Additionally, psychosocial ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02470468

Evaluation of Safety and Efficacy of DCVAC/LuCa ...

The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39817729/

Supporting community translation of lung cancer screening

LuCaS CHOICES is a web-based decision aid designed to support informed decision-making about LCS among individuals at higher risk of lung cancer.

4.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00149-4/fulltext

Projected effectiveness of lung cancer screening and ...

The NELSON trial demonstrated a 24% intention-to-screen reduction in lung cancer mortality from regular screening with low-dose computed tomography.

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/14796694.2025.2475733?src=exp-la

Full article: Improving lung cancer decision-making using a ...

This trial evaluates the effectiveness of a low-literacy conversation tool for patients with newly diagnosed stage I-IV NSCLC to improve SDM during encounters ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06636721

Improving Well-being for Older Adults With Lung Cancer

The purpose of this study is to develop a brief assessment and need-based behavioral intervention for addressing aging-specific concerns in older adults ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10921523/

Efficacy of a digital lifestyle intervention on health-related ...

We aim to investigate the effect of a 12-week digital lifestyle intervention on HRQoL and lifestyle-related outcomes in NSCLC survivors after completion of ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02613637

Registry Study on Biological Disease Profile and Clinical ...

All patients with newly diagnosed or existent lung cancer of all LuCa BiO centers in Germany are intended to be registered with in the LuCa BiO Registry. Ages ...

9.

ichgcp.net

ichgcp.net/amp/clinical-trials-registry/NCT06636721

LuCA Behavioral Intervention in Lung Cancer - ICH GCP

The purpose of this study is to develop a brief assessment and need-based behavioral intervention for addressing aging-specific concerns in older adults ...