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This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy (ADT) for prostate cancer
Androgen deprivation therapy (ADT) is a key treatment of prostate cancer. While this therapy improves prostate cancer outcomes, ADT also has a variety of short- and long-term adverse effects, including increased body weight, loss of lean muscle mass, reductions in quality of life, and increased risk of cardiovascular disease. Studies have shown that among men with prostate cancer, physical activity is associated with improved outcomes, including a reduced risk of mortality, from prostate cancer and other causes. Our hypothesis is that physical activity will improve some of the physical and emotional side effects associated with ADT. Physical activity, such as brisk walking and moderate strength training, offers a lifestyle factor that may improve some of the side effects, and is low-cost and easy to do.
The investigators are conducting this study to evaluate the impact and feasibility of a 12-week moderate-intensity aerobic and strength training exercise intervention, including a virtual component. The intervention includes brisk walking and moderate strength training, and involves home-based exercises, in-person sessions with an oncology-trained exercise physiologist, optional group training sessions, and weekly training goals. Participants will have access to a personalized web-based platform called Postwire, which will include videos of training sessions, and will allow participants to easily communicate with the study staff and with other study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental |
|
|
| Usual Care | No Intervention | Usual Care provided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | 12-week moderate-intensity aerobic and strength training exercise intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Physical Performance at 12 weeks | The 6 Minute Walk Test will be performed at the clinic, where the participants will wear tennis shoes and will walk indoors on a flat surface for 6 minutes. | Baseline and 12 weeks |
| Change from Baseline in Physiologic Measurements at 12 weeks | Measuring heart rate and resting pulse by counting the number of beats per minute at the wrist of each participant. | Baseline and 12 weeks |
| Change from Baseline in Blood Pressure at 12 weeks | The investigators will obtain participant's blood pressure from the most recent clinical visit. | Baseline and 12 weeks |
| Change from Baseline in Body Composition at 12 weeks | Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. | Baseline and 12 weeks |
| Physical Functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul L. Nguyen, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The investigators will assess changes in physical functioning from study enrollment to the completion of the study period using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3) and the Prostate Cancer Specific EORTC questionnaire.
| Baseline and 12 weeks |
| Minutes of Physical Activity | The investigators will assess changes in activity from baseline to 12-weeks using the 7-Day Physical Activity Recall (PAR) | Baseline and 12 weeks |
| Anthropometric Measures | The investigators will assess changes in height from baseline to 12 weeks using a tape measure. | Baseline and 12 weeks |
| Anthropometric Measures | The investigators will assess changes in weight from baseline to 12 weeks using a scale. | Baseline and 12 weeks |
| Anthropometric Measures | The investigators will assess changes in waist circumference from baseline to 12 weeks using a tape measure. | Baseline and 12 weeks. |
| Biomarkers | The investigators will assess PSA at baseline and 12-weeks in both the usual care and intervention arm. | Baseline and 12 weeks. |
| Biomarkers | The investigators will assess testosterone levels at baseline and 12-weeks in both the usual care and intervention arm. | Baseline and 12 weeks. |
| Measure adherence | The investigators will evaluate adherence rates to study procedures by using self-report and FitBit | Baseline and 12 weeks |
| Measure feasibility | Feasibility measured by number of eligible members of the targeted population | Baseline and 12 weeks |
| Measure feasibility | Feasibility measured by recruitment rates | Baseline and 12 weeks |
| Measure feasibility | Feasibility measured by refusal rates for participation and randomization | Baseline and 12 weeks |
| Measure feasibility | Feasibility measured by level of engagement with Postwire and with other study participants. | Baseline and 12 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |