Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study (PACMen)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exrecise intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring physical activity
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed with prostate cancer
- will not start treatment for at least 2 weeks
- able to read and understand English
- capable of giving informed consent
- at least 18 years old
Exclusion Criteria:
- patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
- unable to provide informed consent as assessed by the interviewer
- too sick to participate, as judged by a member of the research team or the exercise physiologist
- have been treated for another cancer
Sites / Locations
- Duke Raleigh Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
subjects with prostate cancer
Arm Description
Outcomes
Primary Outcome Measures
Change in 6 minute walk test
Distance walked in 6 minutes
Change in balance test
Ability to balance
Change in time up to go test
Time to get up from chair, walk 30 meters and return to sit in chair
Change in Godin Leisure Time Score
physical activity score
Change in rate of perceived exertion
physical exertion score
Change in metabolic equivalent
metabolic activity score
Change in distress score
distress score
Change in self-efficacy score
self-efficacy score
Change in symptom inventory score
description of symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03331458
Brief Title
Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
Acronym
PACMen
Official Title
Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
March 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.
The purpose of this study is to
Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and
Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:
Examine intervention safety and tolerance by self-report
Examine changes in functional capacity by 6-minute walk test
Examine changes in symptom experience by self-report
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
physical activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subjects with prostate cancer
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
exrecise intervention
Intervention Description
Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures
Primary Outcome Measure Information:
Title
Change in 6 minute walk test
Description
Distance walked in 6 minutes
Time Frame
baseline, 2 weeks post intervention
Title
Change in balance test
Description
Ability to balance
Time Frame
baseline, 2 weeks post intervention
Title
Change in time up to go test
Description
Time to get up from chair, walk 30 meters and return to sit in chair
Time Frame
baseline, 2 weeks post intervention
Title
Change in Godin Leisure Time Score
Description
physical activity score
Time Frame
baseline, 2 weeks post intervention
Title
Change in rate of perceived exertion
Description
physical exertion score
Time Frame
baseline, 2 weeks post intervention
Title
Change in metabolic equivalent
Description
metabolic activity score
Time Frame
baseline, 2 weeks post intervention
Title
Change in distress score
Description
distress score
Time Frame
baseline, 2 weeks post intervention
Title
Change in self-efficacy score
Description
self-efficacy score
Time Frame
baseline, 2 weeks post intervention
Title
Change in symptom inventory score
Description
description of symptoms
Time Frame
baseline, 2 weeks post intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed with prostate cancer
will not start treatment for at least 2 weeks
able to read and understand English
capable of giving informed consent
at least 18 years old
Exclusion Criteria:
patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
unable to provide informed consent as assessed by the interviewer
too sick to participate, as judged by a member of the research team or the exercise physiologist
have been treated for another cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Allen
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Raleigh Cancer Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27606
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share feasibility study data
Learn more about this trial
Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
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