Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca (BETR-PC)

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: Behavioral Exercise Training (BET) intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06250751

HM20028651 (Other Identifier)

MCC-23-20769

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 41 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Exercise Training (BET) intervention