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Behavioral Intervention

Exercise for Lung Cancer

N/A

Recruiting

Led By Tarah J Ballinger, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Known diagnosis of locally advanced (stage III) or metastatic NSCLC

Age ≥ 18 years

Must not have

Medical co-morbidities that preclude patient from participating in supervised exercise, including but not limited to: Advanced heart failure, Advanced respiratory disease requiring home oxygen use, Uncontrolled psychiatric disorders, History of fragility fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date open to accrual until closed to accrual, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a combination of different types of exercise can help people with advanced lung cancer live longer, stay active, and have a better quality of life."

Who is the study for?

This trial is for adults over 18 with advanced lung cancer (stage III or metastatic NSCLC) who are on maintenance immunotherapy. They must have internet and equipment for virtual exercise, be stable or responding to current therapy, and not already doing regular moderate/vigorous exercise. Excluded are those with severe heart/respiratory conditions, uncontrolled psychiatric disorders, or a history of fragile bones.

What is being tested?

The study tests how an at-home multimodal exercise program affects survival, function, and quality of life in patients with advanced lung cancer. Participants will engage in supervised exercises virtually while continuing their maintenance immunotherapy treatment.

What are the potential side effects?

Since the intervention involves physical exercise tailored to individuals' capabilities, potential side effects may include typical exercise-related issues such as muscle soreness or strain but should generally be minimal given the supervision.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is at stage III or has spread beyond.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I do not have severe heart or lung problems, uncontrolled mental health issues, or a history of easy bone fractures that would stop me from doing supervised exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date open to accrual until closed to accrual, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date open to accrual until closed to accrual, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and date open to accrual until closed to accrual, up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in patient-reported fatigue

Secondary study objectives

Adherence with the intervention defined

Change in cardiorespiratory fitness

Change in depression

+5 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: Exercise InterventionExperimental Treatment1 Intervention

Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session.

Group II: Usual CareActive Control1 Intervention

Participants randomized to usual care arm will receive care per their treatment team. Usual care participants are encouraged to exercise but will not be provided components of the intervention. Participants in the usual care arm will be given usual care handouts at baseline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Intervention

2016

Completed Phase 4

~1330

0 / 4Eligibility criteria met