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Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study (PACMen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331458
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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

  1. Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and
  2. Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:

    1. Examine intervention safety and tolerance by self-report
    2. Examine changes in functional capacity by 6-minute walk test
    3. Examine changes in symptom experience by self-report

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: exrecise intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
Actual Study Start Date : April 17, 2018
Actual Primary Completion Date : March 21, 2019
Actual Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: subjects with prostate cancer Behavioral: exrecise intervention
Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures




Primary Outcome Measures :
  1. Change in 6 minute walk test [ Time Frame: baseline, 2 weeks post intervention ]
    Distance walked in 6 minutes

  2. Change in balance test [ Time Frame: baseline, 2 weeks post intervention ]
    Ability to balance

  3. Change in time up to go test [ Time Frame: baseline, 2 weeks post intervention ]
    Time to get up from chair, walk 30 meters and return to sit in chair

  4. Change in Godin Leisure Time Score [ Time Frame: baseline, 2 weeks post intervention ]
    physical activity score

  5. Change in rate of perceived exertion [ Time Frame: baseline, 2 weeks post intervention ]
    physical exertion score

  6. Change in metabolic equivalent [ Time Frame: baseline, 2 weeks post intervention ]
    metabolic activity score

  7. Change in distress score [ Time Frame: baseline, 2 weeks post intervention ]
    distress score

  8. Change in self-efficacy score [ Time Frame: baseline, 2 weeks post intervention ]
    self-efficacy score

  9. Change in symptom inventory score [ Time Frame: baseline, 2 weeks post intervention ]
    description of symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331458


Locations
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United States, North Carolina
Duke Raleigh Cancer Center
Raleigh, North Carolina, United States, 27606
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Deborah Allen Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03331458    
Other Study ID Numbers: Pro00083320
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share feasibility study data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
physical activity
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases