Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors



Status:Not yet recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:June 2016
Contact:Ohio State University Comprehensive Cancer Center
Email:Jamesline@osumc.edu
Phone:1-800-293-5066

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This pilot clinical trial studies quality of life and supportive care preferences following
radiation therapy in prostate cancer survivors. Studying quality of life and supportive care
preferences in patients undergoing radiation therapy may help identify the effects of
treatment on patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To develop an understanding of the impacts of prostate cancer on aspects of psychological
stress, physiological stress and health related quality of life (HRQL) for men who are being
treated with some level of radiation therapy (RT).

II. To gain insight into the perceived needs of survivors depending on their disease stage,
treatment regimen and side effects.

SECONDARY OBJECTIVES:

I. To explore whether biomarkers of stress, inflammation and autonomic control (heart rate
variability [HRV]) can confirm or dispel the self-reported measures of psychological
distress and HRQL of a unique population of aging men with prostate cancer.

OUTLINE:

Participants complete questionnaires about quality of life and preferences for supportive
care treatment, undergo heart rate variability testing over 10-15 minutes while both lying
down and standing, complete a walking test, wear an accelerometer for a period of 1 week,
and undergo a single intelligent dual-energy X-ray absorptiometry (iDXA) scan over 10
minutes.

Inclusion Criteria:

- English speaking

- Diagnosis of prostate cancer

- Treatment with primary radiation (brachytherapy or external beam therapy), radiation
+ androgen deprivation therapy (ADT) or salvage prostatectomy

- Body mass index (BMI) (26 - 40 kg/m^2)

- Treating oncologist consent

- Ambulatory or able to engage in walking for at least 45 minutes per intervention
visit

- Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking,
cycling or swimming per week

Exclusion Criteria:

- Poor diagnosis or other cancer

- Severe heart or systemic disease: evidence of documented myocardial infarction,
chronic unstable angina, symptomatic congestive heart failure, uncontrolled
hypertension

- Severe musculoskeletal disease: severe muscle or joint disorders due to disease or
trauma, amputations, or any condition that significantly impair physical
capabilities, as defined by the physician

- Non-ambulatory

- Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or
significant sensory deficit

- Major mental illness (e.g., schizophrenia, major depressive disorder)

- Unwilling to give consent
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Brian C. Focht, PhD, FACSM, CSCS
Phone: 614-292-0757
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mi
from
Columbus, OH
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