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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: exrecise intervention

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27606
      • Duke Raleigh Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 minute walk test	Distance walked in 6 minutes	baseline, 2 weeks post intervention
Change in balance test	Ability to balance	baseline, 2 weeks post intervention
Change in time up to go test	Time to get up from chair, walk 30 meters and return to sit in chair	baseline, 2 weeks post intervention
Change in Godin Leisure Time Score	physical activity score	baseline, 2 weeks post intervention
Change in rate of perceived exertion	physical exertion score	baseline, 2 weeks post intervention
Change in metabolic equivalent	metabolic activity score	baseline, 2 weeks post intervention
Change in distress score	distress score	baseline, 2 weeks post intervention
Change in self-efficacy score	self-efficacy score	baseline, 2 weeks post intervention
Change in symptom inventory score	description of symptoms	baseline, 2 weeks post intervention

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Deborah Allen, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): March 21, 2019
• Study Completion (Actual): March 21, 2019

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: physical activity
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Pro00083320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share feasibility study data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No