What side effects are associated with this type of intervention?

Common treatments for lung cancer, such as surgery, chemotherapy, and radiation therapy, have several known side effects. Surgery can lead to pain, infection, and reduced lung function. Chemotherapy often causes nausea, vomiting, fatigue, hair loss, and increased risk of infection due to lowered white blood cell counts. Radiation therapy can result in skin irritation, fatigue, and difficulty swallowing if the esophagus is in the treatment area. These treatments can also lead to long-term effects such as pulmonary dysfunction and cardiovascular issues. Personalized guidance and motivational support via telecommunication, like telephone-based physical activity coaching, aim to mitigate some of these side effects by improving physical function and overall well-being.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of lung cancer, including targeted therapies and immunotherapies. Notable examples include pembrolizumab (Keytruda), an immunotherapy that targets PD-1/PD-L1 pathways, and osimertinib (Tagrisso), a targeted therapy for EGFR-mutated non-small cell lung cancer. While these treatments focus on directly combating cancer, the trial mentioned involves telephone-based physical activity coaching, which aims to improve physical function and overall well-being in patients undergoing lung cancer surgery. This approach complements pharmacological treatments by addressing the functional declines associated with surgery.

What other types of research exist?

Promising, novel alternatives to telephone-based physical activity coaching for lung cancer patients include: 1) Mobile health (mHealth) apps that provide real-time monitoring and feedback on physical activity, 2) Web-based interactive platforms offering personalized exercise plans and virtual coaching, 3) Wearable technology integrated with telehealth services for continuous activity tracking and remote support, and 4) Virtual reality (VR) programs designed to engage patients in physical activity through immersive experiences.

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Physical Activity Coaching for Lung Cancer

N/A

Recruiting

Led By Dan Raz, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 65 years

Scheduled to undergo lung surgery for lung cancer or suspected lung cancer with curative intent (neoadjuvant therapy allowed)

Must not have

Lung surgery is scheduled in less than 14 calendar days from the time of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30, 60 and 180 days post discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial compares telephone-based exercise coaching to self-monitored exercise for older adults having lung cancer surgery. The goal is to see if coaching helps improve their physical function more than just giving them written instructions. The coaching involves personalized exercise plans and motivational support.

Who is the study for?

This trial is for older adults scheduled for lung cancer surgery and their caregivers. It aims to see if phone coaching or self-monitoring can help maintain physical function during this time. Participants should be able to perform basic exercises and have access to a telephone.

What is being tested?

The study tests two methods: one where participants receive regular phone calls from a coach who guides them through physical activities, and another where they monitor their own exercise routine without guidance.

What are the potential side effects?

Since the interventions involve non-invasive techniques like exercise and educational support, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I am scheduled for lung surgery with the aim to cure lung cancer.

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I am 18 years old or older.

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I can read and understand English or Spanish and am willing to complete surveys about my health.

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I have been diagnosed with lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung surgery is scheduled within the next 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30, 60 and 180 days post discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30, 60 and 180 days post discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30, 60 and 180 days post discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective patient functional capacity

Secondary study objectives

Caregiver reported quality of life

Functional capacity

Hospital readmissions

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (Telephone-based coaching session)Experimental Treatment6 Interventions

Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial.

Group II: Arm II (Written education)Active Control5 Interventions

Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung cancer include surgery, which physically removes tumors; radiation therapy, which uses high-energy rays to kill cancer cells; chemotherapy, which uses drugs to destroy cancer cells; targeted therapy, which attacks specific cancer cell molecules; and immunotherapy, which boosts the body's immune system to fight cancer. These treatments are crucial as they aim to eliminate cancer, control its spread, and improve survival rates. Telephone-based physical activity coaching complements these treatments by enhancing physical function and quality of life, helping patients manage treatment side effects and maintain overall health.

Effects of physical activity on the quality of life in taiwanese lung cancer patients receiving active treatment or off treatment.The management of non-small-cell lung cancer: a case history.