Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca
Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Kendra Rowe
- 804-828-1965
- [email protected]
Principal Investigator
- Alexander Lucas, PhD
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).
Study Plan
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) interventionDescription:
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.
Outcome Measures
Primary Outcome Measures
Feasibility of trial by assessing the recruitment rate
Feasibility of trial by assessing the retention rate
Acceptability of the trial by assessing the retention rate
Secondary Outcome Measures
Physical activity levels using accelerometry (ActivPAL, Actigraph)
Physical activity levels using the Godin-Leisure Time Exercise Questionnaire (GLTEQ).
Submaximal exercise capacity assessed with the 6-minute walk test.
Physical function as assessed with the short physical performance battery (SPPB).
Lower body strength assessed with a 30 seconds chair stand test.
Upper body strength assessed with a grip strength dynamometer.
Self-efficacy for exercise using the exercise self-efficacy scale (EXSE) to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns
Social support for exercise scale to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns
Walk Score to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns
Assess health-related quality of life (HRQL) using the Functional Assessment of Cancer Therapy-Fatigue scale (FACIT-fatigue)
Assess disease specific quality of life (HRQL) using the 42-item Functional Assessment of Cancer Treatment-Prostate (FACT-P)
Assess health-related quality of life (HRQL) using the the MOS 36-item Short Form Health Survey (SF-36)
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Scale 4a
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Scale 4a
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Scale 4a
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Scale 4a
Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale 4a
Assess health-related quality of life (HRQL) using Social Determinants of Health
Timeline
Last Updated
February 12, 2024Start Date
February 9, 2024Today
January 16, 2025Completion Date ( Estimated )
August 31, 2025
Sponsors of this trial
Lead Sponsor
Virginia Commonwealth UniversityCollaborating Sponsors
NRG Oncology