Clinical trial NCT06250751: Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca
Official title: Behavioral Exercise TRaining for Medically Underserved Men Undergoing Androgen Deprivation Therapy for Prostate Cancer (BETR-PC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Exercise
Prostate Cancer
Androgen Deprivation Therapy (ADT)
Home Based Exercise Intervention
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: NRG Oncology
First posted: 2024-02-09
Enrollment: 30
Sex: MALE
Minimum age (years): 41
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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).

Primary outcomes:
measure: Feasibility of trial by assessing the recruitment rate
timeFrame: Day 1
measure: Feasibility of trial by assessing the retention rate
timeFrame: 12 Weeks
measure: Acceptability of the trial by assessing the retention rate
timeFrame: 12 Weeks
Secondary outcomes:
measure: Physical activity levels using accelerometry (ActivPAL, Actigraph)
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Physical activity levels using the Godin-Leisure Time Exercise Questionnaire (GLTEQ).
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Submaximal exercise capacity assessed with the 6-minute walk test.
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Physical function as assessed with the short physical performance battery (SPPB).
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Lower body strength assessed with a 30 seconds chair stand test.
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Upper body strength assessed with a grip strength dynamometer.
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: 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
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Social support for exercise scale to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Walk Score to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess health-related quality of life (HRQL) using the Functional Assessment of Cancer Therapy-Fatigue scale (FACIT-fatigue)
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess disease specific quality of life (HRQL) using the 42-item Functional Assessment of Cancer Treatment-Prostate (FACT-P)
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess health-related quality of life (HRQL) using the the MOS 36-item Short Form Health Survey (SF-36)
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Scale 4a
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Scale 4a
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Scale 4a
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Scale 4a
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale 4a
timeFrame: Baseline, 8 Weeks, and 12 Weeks
measure: Assess health-related quality of life (HRQL) using Social Determinants of Health
timeFrame: Baseline, 8 Weeks, and 12 Weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alexander Lucas, PhD
role: PRINCIPAL_INVESTIGATOR
References: