Behavioral Exercise Training for Medically Underserved Men Undergoing Androgen Deprivation Therapy for Stage II-IV Prostate Cancer, BETR-PC Trial

Status: closed to accrual

This clinical trial tests the effect of participating in a physical activity intervention in patients undergoing androgen deprivation therapy (ADT) for stage II-IV prostate cancer (PC). ADT leads to harmful changes in body composition and metabolic functioning that worsens fatigue, exercise intolerance, and increases future risk for cardiovascular disease (CVD). Men with PC who live in rural areas experience disparities in PC care and have worse outcomes than those living in urban settings. Exercise training is an effective non-pharmacological approach to treating both the side-effects of PC therapy and CVD. Information gathered from this study may help researchers determine whether participating in a behavioral exercise training program helps preserve exercise capability and quality of life, as well as lessening the side effects from ADT in patients with stage II-IV PC.

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 Health Insurance Portability and Accountability Act (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
We will also require men to meet our definition of medically underserved: Here, we consider medically underserved patients to be * Older men (> 75 years) * Men who live in rural zip code areas, or * 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).

PRIMARY OBJECTIVE:

I. To iteratively refine a 12-week, behavioral exercise training (BET) intervention among 30 men currently undergoing ADT.

SECONDARY OBJECTIVE:

I. To determine the preliminary efficacy and fidelity of the proposed BET intervention among all 30 underserved PC patients by examining changes in activity levels, submaximal exercise capacity, physical function and adherence to the program.

OUTLINE:

Patients participate in the BET intervention for 12 weeks consisting of home-based exercise and behavioral counseling sessions to support adoption and maintenance of exercise and to troubleshoot any barriers. Behavioral counseling sessions occur twice per week (BIW) during weeks 1-2, once per week (QW) during weeks 3-8, and once every two weeks (Q2W) during weeks 9-12. Patients also wear ActivPAL and Actigraph devices for monitoring physical activity for 7-10-days.

After completion of study intervention, patients are followed up at 30 days.

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Behavioral Exercise Training for Medically Underserved Men Undergoing Androgen Deprivation Therapy for Stage II-IV Prostate Cancer, BETR-PC Trial

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