Prostate Cancer
Conditions
Keywords
Prostate cancer, External beam radiation treatment, Androgen deprivation therapy, Definitive treatment, Cardiovascular risk factors, Quality of life
Brief summary
This study will evaluate the proportion of prostate cancer patients receiving external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) with controlled blood sugars (fasting glucose and hemoglobin A1c), blood pressure, and cholesterol profile (total cholesterol, LDL, HDL, triglycerides) at baseline, 3 months, and 12 months after completing radiation treatment. In addition, receipt of guideline-recommended cardiovascular, primary and preventive care as well as patient-reported quality of life and satisfaction with care among these patients will be evaluated at baseline and 12 months.
Interventions
None listed
Sponsors
Radiation Therapy Oncology Group
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically-confirmed, non-metastatic prostate cancer * Patients who will receive external beam radiation treatment with androgen deprivation therapy (total ADT duration \> 3 months) for curative treatment, either in the definitive or post-prostatectomy setting * Patients who have a primary care provider * Informed consent obtained and signed * Ability to read and write English * Age \>= 18 * No mental incompetence which would preclude completion of questionnaires
Exclusion criteria
* Prior cancer, pelvic radiation treatment or chemotherapy * Patients who do not have a primary care provider * Prior ADT * Mental incompetence which would preclude completion of questionnaires * Unable to read and write English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. | Baseline | Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides. Baseline is prior to receiving androgen deprivation therapy and prior to radiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement). | Baseline | This will be done by patient self-report and by medical record review (radiation oncologist will obtain medical records from patient's primary care physician). |
| Proportion of prostate cancer patients who receive other (non-cardiovascular) guideline-recommended primary and preventive care (flu vaccination, colorectal cancer screening, and healthy lifestyle counseling). | Baseline | This will be done by patient self-report and by medical record review (radiation oncologist will obtain medical records from patient's primary care physician). |
| Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile. | 3 months post radiation treatment completion | Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides. |
| Patient-reported coordination of care. | Baseline | — |
| Patient-reported satisfaction with care. | Baseline | — |
| Patient-reported quality of life. | Baseline | — |
Countries
United States
Outcome results
None listed