A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery

Study Overview
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Brief Summary
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The paradigm of pre-operative exercise as a neoadjuvant therapy to reduce morbidity is increasingly promoted within general surgery and surgical oncology. Patients with lung cancer participating in pre-operative exercise have better aerobic capacity and pulmonary function and shorter hospital length-of-stay after surgery. Additionally, pre-operative exercise may increase the likelihood of resuming exercise post-surgery, thereby accelerating the pace of rehabilitation and recovery. In order to translate the research findings into sustainable clinical practice, clinician-scientists need to develop pragmatic and effective home-based exercise protocols. Wearable fitness devices offer a way to approximate the supervision that occurs in exercise research. Before the investigators can develop an intervention in which patients receive tailored support similar to what occurs with supervised exercise, they need to pilot test the monitoring aspect of the wearable fitness device in conjunction with the pre-operative exercise program. The investigators propose a mixed methods, 16 single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will identify the strengths, weaknesses, and utility of this approach.

Detailed Description
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The investigators propose a parallel mixed methods, 16 single arm, pre-post study with 30 participants scheduled for lung cancer surgery. At time of enrollment (at least 3 weeks before their scheduled surgery), participants will complete baseline assessments, receive the uPEP exercise prescription, and be oriented to the wearable fitness device. A research assistant will call the participant to conduct an audiotaped semi-structured interview regarding the acceptability of the electronically-monitored uPEP within 7- 14 days of enrollment. The study team will complete follow-up assessments on the day of surgery, two weeks after surgery, and four months after surgery. Data will also be collected from chart review and the wearable fitness device throughout the study.

Official Title
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A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will recruit English-speaking patients who: Are over the age of 18 and diagnosed with Stage I-III lung cancer; Are able to tolerate surgery (i.e., segmentectomy, lobectomy or bilobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiac evaluation (if indicated); Access to either Wi-Fi or cellular service and permission/ability to download the wearable fitness device app on an apple device, android, or computer (or willingness to use a study-provided iPod to allow the data to be uploaded to the study team); Are able to provide voluntary, written consent. Exclusion Criteria: Participants will be excluded based on electronic health record (EHR) review (after obtaining HIPAA waiver) if they: Have a life expectancy of < 12 months or are receiving hospice services; Have a psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation; Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina;31 Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The investigators propose a mixed methods,16 single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will identify the strengths, weaknesses, and utility of this approach.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm<br>exercise | Behavioral: Exercise<br>* single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to exercise: | number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log | Time 3, day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment: | number of patients enrolled divided by number of patients eligible | Time 5, 16 weeks post-surgery | 
| Acceptance of technology | number of hours the fitness tracker was worn in pre-operative period | Time 3, day of surgery | 
| Participant perception of exercise program | semi-structured interview regarding perceptions of the exercise program | Time 2, 3-5 days before surgery | 
| Participant perception of fitness tracker | semi-structured interview regarding perceptions of the fitness tracker | Time 2, 3-5 days before surgery | 
| Subjective minutes spent in exercise | Number of minutes spent in exercise according to exercise log | Time 3, day of surgery | 
| Objective minutes spent in exercise: | Number of minutes spent in exercise according to fitness tracker | Time 3, day of surgery | 
| Aerobic capacity: | Six minute walk test | Time 3, day of surgery | 
| Pulmonary function: | Diffusion of lungs for carbon monoxide test | Time 2, 3-5 days before surgery | 
| Subjective physical function: | PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale | Time 2, 3-5 days before surgery | 
| Objective physical function: | Grip strength per dynamometer | Time 3, day of surgery | 
| Length of stay in hospital: | Number of days from surgery to discharge home | Time 4, 2 weeks post-surgery | 
| Feasibility of Retention | Number of patients completing all study assessments divided by the number enrolled | 16 weeks post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, exercise, pre-operative exercise program