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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, exercise, pre-operative exercise program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single arm

Arm Description

exercise

Outcomes

Primary Outcome Measures

Adherence to exercise:
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2017
Last Updated
March 4, 2019
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Norris Cotton Cancer Center, Dartmouth College
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1. Study Identification

Unique Protocol Identification Number
NCT03162718
Brief Title
A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery
Official Title
A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
February 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Norris Cotton Cancer Center, Dartmouth College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, exercise, pre-operative exercise program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Other
Arm Description
exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.
Primary Outcome Measure Information:
Title
Adherence to exercise:
Description
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
Time Frame
Time 3, day of surgery
Secondary Outcome Measure Information:
Title
Feasibility of recruitment:
Description
number of patients enrolled divided by number of patients eligible
Time Frame
Time 5, 16 weeks post-surgery
Title
Acceptance of technology
Description
number of hours the fitness tracker was worn in pre-operative period
Time Frame
Time 3, day of surgery
Title
Participant perception of exercise program
Description
semi-structured interview regarding perceptions of the exercise program
Time Frame
Time 2, 3-5 days before surgery
Title
Participant perception of fitness tracker
Description
semi-structured interview regarding perceptions of the fitness tracker
Time Frame
Time 2, 3-5 days before surgery
Title
Subjective minutes spent in exercise
Description
Number of minutes spent in exercise according to exercise log
Time Frame
Time 3, day of surgery
Title
Objective minutes spent in exercise:
Description
Number of minutes spent in exercise according to fitness tracker
Time Frame
Time 3, day of surgery
Title
Aerobic capacity:
Description
Six minute walk test
Time Frame
Time 3, day of surgery
Title
Pulmonary function:
Description
Diffusion of lungs for carbon monoxide test
Time Frame
Time 2, 3-5 days before surgery
Title
Subjective physical function:
Description
PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale
Time Frame
Time 2, 3-5 days before surgery
Title
Objective physical function:
Description
Grip strength per dynamometer
Time Frame
Time 3, day of surgery
Title
Length of stay in hospital:
Description
Number of days from surgery to discharge home
Time Frame
Time 4, 2 weeks post-surgery
Title
Feasibility of Retention
Description
Number of patients completing all study assessments divided by the number enrolled
Time Frame
16 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen D Lyons, ScD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David J Finley, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33813267
Citation
Finley DJ, Stevens CJ, Emond JA, Batsis JA, Fay KA, Darabos C, Sacks OA, Cook SB, Lyons KD. Potential effectiveness of a surgeon-delivered exercise prescription and an activity tracker on pre-operative exercise adherence and aerobic capacity of lung cancer patients. Surg Oncol. 2021 Jun;37:101525. doi: 10.1016/j.suronc.2021.101525. Epub 2021 Mar 5.
Results Reference
derived
PubMed Identifier
32469129
Citation
Finley DJ, Fay KA, Batsis JA, Stevens CJ, Sacks OA, Darabos C, Cook SB, Lyons KD. A feasibility study of an unsupervised, pre-operative exercise program for adults with lung cancer. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13254. doi: 10.1111/ecc.13254. Epub 2020 May 29.
Results Reference
derived

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

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