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

NCT ID: NCT03331458

Last Updated: 2019-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2019-03-21

Brief Summary

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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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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subjects with prostate cancer

Group Type EXPERIMENTAL

exrecise intervention

Intervention Type BEHAVIORAL

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

Interventions

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exrecise intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah Allen

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Raleigh Cancer Center

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00083320

Identifier Type: -

Identifier Source: org_study_id

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