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Trial Title:
Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca
NCT ID:
NCT06250751
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Exercise
Prostate Cancer
Androgen Deprivation Therapy (ADT)
Home Based Exercise Intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Exercise Training (BET) intervention
Description:
Introduce and refine concept of exercise and cardiovascular health by initiating walking
or cycling and provide behavioral counseling sessions to foster support for adoption and
maintenance of exercise, and to troubleshoot barriers. During the first two weeks, the
study team will meet with participants twice per week (virtually) to introduce the
intervention, familiarize men with the exercise program, exercise logs, resistance bands
for strength training. Contact will drop to once per week during weeks 3-8 (total=10
contacts in weeks 1-8). Behavioral counseling will be delivered by the PI or the study
coordinator for 30-40 minutes prior to 20-30 mins of an individual or group-based
strength training class.
Arm group label:
Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise program
Summary:
To refine a remote behavioral exercise training intervention for testing in a larger
randomized trial.
Detailed description:
Determine feasibility of recruiting a sample of medically underserved prostate cancer
patients undergoing treatment with Androgen Deprivation Therapy (ADT) to a remotely
delivered (i.e., home-based) exercise intervention and determine the interventions
acceptability.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Be diagnosed with stage II/III/IV prostate cancer
- Be currently undergoing treatment with ADT (intermittent or prolonged)
- Have completed local curative-intent treatment, including prostatectomy or
definitive radiation
- Be >40 years of age if non-Hispanic Black or rural dwelling; Otherwise >60 years of
age up to 85
- Be willing to give an informed consent and sign a HIPAA authorization form
- Not have any hearing or sight impairments that result in the inability to use the
telephone or hear normal conversation
- Must be able to join an intervention group by personal computer, smartphone or
telephone call and should agree to recording of an interview
- Be without any serious medical condition that precludes safe participation in an
exercise program
- Speak English.
- Meet protocol definition of medically underserved: which is consider medically
underserved patients to be a) older men (>75 years), b) men who live in rural zip
code areas, or c) men who identify as being non-Hispanic Black. They may also be at
the intersectionality of these groups (i.e., older Black men living in a rural zip
code area).
Gender:
Male
Minimum age:
41 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kendra Rowe
Phone:
804-828-1965
Email:
rowek2@vcu.edu
Contact backup:
Last name:
Massey CPC DWG
Phone:
804-828-1965
Email:
masseycpc@vcu.edu
Investigator:
Last name:
Alexander R Lucas, PhD
Email:
Principal Investigator
Start date:
February 5, 2024
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Virginia Commonwealth University
Agency class:
Other
Collaborator:
Agency:
NRG Oncology
Agency class:
Other
Source:
Virginia Commonwealth University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06250751
