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

Clinicaltrials.gov ID: NCT06250751
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age 41 - 85 Years
b-bullseye-arrow Enrollments 30

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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) intervention

    Description:

    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

Time Frame: Day 1

Feasibility of trial by assessing the retention rate

Time Frame: 12 Weeks

Acceptability of the trial by assessing the retention rate

Time Frame: 12 Weeks

Secondary Outcome Measures

Physical activity levels using accelerometry (ActivPAL, Actigraph)

Time Frame: Baseline, 8 Weeks, and 12 Weeks

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

Time Frame: Baseline, 8 Weeks, and 12 Weeks

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

Time Frame: Baseline, 8 Weeks, and 12 Weeks

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

Time Frame: Baseline, 8 Weeks, and 12 Weeks

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

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Upper body strength assessed with a grip strength dynamometer.

Time Frame: Baseline, 8 Weeks, and 12 Weeks

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

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Social support for exercise scale to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Walk Score to assess socioecological model constructs as multilevel factors associated with physical activity levels and behavioral patterns

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess health-related quality of life (HRQL) using the Functional Assessment of Cancer Therapy-Fatigue scale (FACIT-fatigue)

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess disease specific quality of life (HRQL) using the 42-item Functional Assessment of Cancer Treatment-Prostate (FACT-P)

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess health-related quality of life (HRQL) using the the MOS 36-item Short Form Health Survey (SF-36)

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Scale 4a

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Scale 4a

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Scale 4a

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Scale 4a

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess health-related quality of life (HRQL) using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale 4a

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Assess health-related quality of life (HRQL) using Social Determinants of Health

Time Frame: Baseline, 8 Weeks, and 12 Weeks

Timeline

  • Last Updated
    February 12, 2024
  • Start Date
    February 9, 2024
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    August 31, 2025

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