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

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. ^{1 2 3 4 5}

Is 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. ^{2 6 7 8 9}

How 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. ^{2 3 4 6 10}

Research Team

Rebecca A Shelby, PhD

Principal Investigator

Duke Psychiatry & Behavioral Sciences

Eligibility 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

Exclusion Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Behavioral interventions for lung cancer-related breathlessness. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

Enhancing behavioral change among lung cancer survivors participating in a lifestyle risk reduction intervention: a qualitative study. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Lifestyle behaviors and intervention preferences of early-stage lung cancer survivors and their family caregivers. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Analysis of Hazard Factors Affecting the Quality of Life for Lung Cancer Patients after Chemotherapy. [2023]

8. England 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Behavior and cancer prevention. [2022]