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

NCT03331458 | Completed

• 1 other identifier: Pro00083320
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. 1.Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and
2. 2.Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:
3. 3.Examine intervention safety and tolerance by self-report
4. 4.Examine changes in functional capacity by 6-minute walk test
5. 5.Examine changes in symptom experience by self-report

Conditions

Prostate Cancer

Keywords

physical activity

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

subjects with prostate cancer

EXPERIMENTAL

Behavioral: exrecise intervention

Interventions

exrecise intervention BEHAVIORAL

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

subjects with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Raleigh Cancer Center

Raleigh, North Carolina, 27606, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Deborah Allen

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: April 17, 2018
• Primary Completion: March 21, 2019
• Study Completion: March 21, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)