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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162718
• Other study ID #: D17044
• Status: Completed
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: February 5, 2019

Study information

• Verified date: March 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• This study will recruit English-speaking patients who:

1. Are over the age of 18 and diagnosed with Stage I-III lung cancer;

2. 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);

3. 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);

4. 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:

1. Have a life expectancy of < 12 months or are receiving hospice services;

2. 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;

3. 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

4. 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Exercise
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College, Norris Cotton Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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