RECRUITING

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

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Prostate CancerSupportive CareExercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.

Official Title

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)

Quick Facts

Study Start:2024-02-21
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06237179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be diagnosed with stage II/III/IV prostate cancer
  2. * Be currently undergoing treatment with ADT (intermittent or prolonged)
  3. * Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
  4. * Be \>40 years of age up to 85;
  5. * Be willing to sign an informed consent with HIPAA authorization form;
  6. * Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
  7. * Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
  8. * Be without any serious medical condition that precludes safe participation in an exercise program;
  9. * Speak English
  1. * Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
  2. * Have contraindications to exercise testing;
  3. * Have pre-existing overt cardiovascular disease/heart failure;
  4. * Active illness/infection;
  5. * Hemoglobin \< 7.0 grams/dL
  6. * Platelet count \< 10 x 109/L

Contacts and Locations

Study Contact

Alexander R Lucas, PhD
CONTACT
804 628-6610
Alexander.Lucas@vcuhealth.org
Alexandra Marshall, MS
CONTACT
804 628-1215
lara.marshall@vcuhealth.org

Principal Investigator

Alexander R Lucas, PhD
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Richmond Veterans Affairs Medical Center
Richmond, Virginia, 23249
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Alexander R Lucas, PhD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-21
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-02-21
Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • Supportive Care
  • Exercise

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Supportive Care