Please select the eligibility criteria that correspond to the clinical trial below.
Title: Feasibility of Endurance Exercise Training on Cardiovascular Risk Factors Following Radical Prostatectomy Among Men With Localized Prostate Cancer; A Community-Based Intervention
Brief Summary: The primary objective is to determine the feasibility and acceptability of a home-based endurance exercise program among men diagnosed with clinically localized prostate cancer.


Options:
A: Inclusion Criteria:

1. Legal age (\>18 years old)
2. An interval of at least 6 weeks between prior radical prostatectomy and study enrollment
3. Karnofsky performance status of at least 70% at study entry
4. Estimated life expectancy of ≥6 months
5. Ability to read and understand English
6. Attending urologist approval
7. Signed informed consent
8. Willingness to be randomized; and
9. No contraindications to exercise as recommended by the American Thoracic Society

Exclusion Criteria:

1. Acute myocardial infarction (6 weeks)
2. Unstable angina
3. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
4. Syncope
5. Acute endocarditis
6. Acute myocarditis or pericarditis
7. Uncontrolled heart failure
8. Acute pulmonary embolus or pulmonary infarction
9. Thrombosis of lower extremities
10. Suspected dissecting aneurysm
11. Uncontrolled asthma
12. Pulmonary edema
13. Room air desaturation at rest ≤85%
14. Respiratory failure
15. Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise; and
16. Mental impairment leading to inability to cooperate
B: Inclusion Criteria:

1) female aged \>18 years, 2) completed primary and adjuvant treatment for breast cancer (patients on hormone treatment such as Tamoxifen will be eligible). Women on chemotherapy will become eligible 6 months after treatment completion, and will remain eligible up to 10 years posttreatment; 3) \<10 years since treatment completion, 4) able to read and speak English, 5) provide consent for medical chart review to extract disease and treatment variables, 6) able to walk unassisted, are 7) sedentary defined as: currently not meeting ACSM/CDC criteria (Pate et al, 1995) for moderate-intensity activity (\>30 mins. per day on \>5 days per week) or vigorous-intensity activity (\>20 mins. on \>3 days per week), and 8) have access to a telephone. -

Exclusion Criteria:

-
C: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma (small cell acinar type) of the prostate

  * Has undergone an extended pattern biopsy (defined as 8+ cores) within the past 2 years OR is scheduled to undergo an extended pattern clinical biopsy within 6 weeks of starting study intervention and is willing to undergo 4 additional research core biopsies
  * No more than 33% of biopsy cores positive (\> 33% of biopsy cores positive allowed if due to microfoci of adenocarcinoma)
  * No more than 50% of the length of a tumor core involved by carcinoma
* Clinical stage T1 or T2a disease
* Previously untreated disease
* Gleason score ≤ 6 with no pattern 4 or 5 histology (Gleason pattern 4 seen as a microfocus \[\< 2 mm in length\] allowed)
* Prostate-specific antigen (PSA) ≤ 10.0 ng/mL (PSA \< 15 ng/mL allowed for patients with benign prostatic hyperplasia or prostatitis)

  * Must have had 3 serum PSA levels performed ≥ 2 weeks apart over the past year to allow calculation of a PSA doubling time

    * No PSA doubling time of \< 3 months
* Has chosen watchful waiting as treatment

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 3 months
* Living in the greater San Francisco Bay Area
* Willing to make comprehensive lifestyle changes
* Baseline dietary fat intake ≥ 15%
* Able to participate in the exercise portion of this study, as determined by the cardiologist or primary care physician
* No limited exercise tolerance precluding participation in the lifestyle intervention component of this study
* No comprehensive lifestyle change similar to the lifestyle intervention used in this study
* No concurrent uncontrolled illness including, but not limited to, any of the following:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Coronary artery disease requiring a revascularization procedure
  * Cardiac arrhythmia
  * Psychiatric illness/social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

* No prior or other concurrent treatment for prostate cancer, including any of the following:

  * Surgery
  * Radiotherapy
  * Hormonal therapy (e.g., leuprolide acetate, bicalutamide, flutamide, goserelin, megestrol acetate, nilutamide, or DES/estrogen)
  * Chemotherapy
  * PC-SPES
  * Investigational agents
* More than 4 weeks since prior and no concurrent finasteride or dutasteride
* More than 4 weeks since prior and no concurrent saw palmetto or any other herbal/nutritional preparation that would affect hormone levels
* More than 4 weeks since prior multivitamin/mineral and/or supplemental soy protein, vitamin E, vitamin C, selenium, fish oil, or any other preparation intended to supplement levels of omega-3 unsaturated fatty acids
* More than 1 month since prior and no concurrent NSAIDs, COX-2-inhibitors, and/or aspirin used for \> 7 consecutive days
D: Inclusion Criteria:

* Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or IIIA breast cancer and who are not currently receiving (and do not plan to receive during the duration of the study) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. The upper age limit of 70 years was chosen to reduce the likelihood of adverse events or study drop-out due to increasing comorbidities (e.g., cardiovascular disease) that occur with age.
* If the patient has undergone a surgical procedure, enrollment will be delayed until ≥ 8 weeks post-procedure.
* English speaking.
* Medical clearance for participation provided by primary care physician or oncologist.
* Participating, on average, in no more than 60 minutes of moderate physical activity or no more than 30 minutes of vigorous activity per week during the past six months.

Exclusion Criteria:

* Diagnosis of dementia or organic brain syndrome.
* Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
* Contraindication to participation in a regular physical activity program.
* Metastatic or recurrent disease.
* Inability to ambulate.
* Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
* Planned travel that would interfere with scheduled study sessions (no travel in the 1st 4 months and no travel ≥ 1 week in the last 8 weeks of the intervention).

Answer: A