RECRUITING

Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy

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Conditions

Androgen Deprivation TherapyProstate CancerProstate Cancer MetastaticLocalized Prostate CancerExercise

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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

The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem. Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.

Official Title

Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial

Quick Facts

Study Start:2022-08-11
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05327465

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:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.
  2. * Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease
  3. * Histologically diagnosed of localized or metastatic prostate cancer
  4. * Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist and/or androgen receptor \[AR\] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment
  5. * Self-identify as Black
  6. * Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist
  7. * Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases
  8. * Speak English and/or Spanish
  9. * Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week
  10. * Willing to travel to DFCI for necessary data collection
  11. * Ability to communicate and complete written forms in English and/or Spanish
  1. * Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist)
  2. * Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise
  3. * Are not English or Spanish speaking
  4. * Patients with secondary diagnosis (with the exception of basal cell carcinoma)
  5. * Participate in more than 60 minutes of moderate or vigorous structured exercise/week
  6. * Unable to travel to DFCI for necessary data collection
  7. * May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.

Contacts and Locations

Study Contact

Christina Dieli-Conwright, PhD, MPH
CONTACT
617-632-3800
ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator

Christina C Dieli-Conwright, PhD, MPH
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Christina C Dieli-Conwright, PhD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

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 Date2022-08-11
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2022-08-11
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Androgen deprivation therapy
  • Localized Prostate Cancer
  • Prostate Cancer Metastatic
  • Exercise

Additional Relevant MeSH Terms

  • Androgen Deprivation Therapy
  • Prostate Cancer
  • Prostate Cancer Metastatic