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

Prostate Cancer Clinical Trial

— PACMen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331458
• Other study ID #: Pro00083320
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: March 21, 2019

Study information

• Verified date: August 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• exrecise intervention
Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures

Locations

Country	Name	City	State
United States	Duke Raleigh Cancer Center	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6 minute walk test	Distance walked in 6 minutes	baseline, 2 weeks post intervention
Primary	Change in balance test	Ability to balance	baseline, 2 weeks post intervention
Primary	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
Primary	Change in Godin Leisure Time Score	physical activity score	baseline, 2 weeks post intervention
Primary	Change in rate of perceived exertion	physical exertion score	baseline, 2 weeks post intervention
Primary	Change in metabolic equivalent	metabolic activity score	baseline, 2 weeks post intervention
Primary	Change in distress score	distress score	baseline, 2 weeks post intervention
Primary	Change in self-efficacy score	self-efficacy score	baseline, 2 weeks post intervention
Primary	Change in symptom inventory score	description of symptoms	baseline, 2 weeks post intervention