Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca

NCT06250751 | Completed DMC

• 2 other identifiers: MCC-23-20769HM20028651
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

To refine a remote behavioral exercise training intervention for testing in a larger randomized trial.

Conditions

Prostate Cancer

Keywords

Exercise; Prostate Cancer; Androgen Deprivation Therapy (ADT); Home Based Exercise Intervention

Outcome Measures

Primary Outcomes (3)

• Feasibility of trial by assessing the recruitment rate

  The number of participants that enroll

  Day 1

• Feasibility of trial by assessing the retention rate

  The number of participants that complete greater than 80% of the planned assessments

  12 Weeks

• Acceptability of the trial by assessing the retention rate

  Number of participants that adhere to and complete the intervention

  12 Weeks

Secondary Outcomes (18)

• Physical activity levels using accelerometry (ActivPAL, Actigraph)

  Baseline, 8 Weeks, and 12 Weeks

• Physical activity levels using the Godin-Leisure Time Exercise Questionnaire (GLTEQ).

  Baseline, 8 Weeks, and 12 Weeks

• Submaximal exercise capacity assessed with the 6-minute walk test.

  Baseline, 8 Weeks, and 12 Weeks

• Physical function as assessed with the short physical performance battery (SPPB).

  Baseline, 8 Weeks, and 12 Weeks

• Lower body strength assessed with a 30 seconds chair stand test.

  Baseline, 8 Weeks, and 12 Weeks

Study Arms (1)

Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise program

EXPERIMENTAL

Single-arm, ORBIT-prospective, multicenter, nonblinded clinical trial, feasibility pilot. The BET intervention will be delivered and refined over 12 weeks. The protocol aim is to enroll men from the same representative groups of underserved men in groups of 5-10, to foster social support and group cohesion.

Behavioral: Behavioral Exercise Training (BET) intervention

Interventions

Behavioral Exercise Training (BET) intervention BEHAVIORAL

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.

Behavioral exercise training (BET) to introduce behavioral skills for adopting an exercise program

Eligibility Criteria

• Age: 41 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible men, transwomen or non-binary individuals must meet the following 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).

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• NRG Oncology: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

DNER protein, human; Methods

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alexander Lucas, PhD

  Virginia Commonwealth 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: January 30, 2024
• First Posted: February 9, 2024
• Study Start: February 5, 2024
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)