Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-15049

Full Title

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

Purpose

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.

Study Objective

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.

Are you eligible?

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

Prostate Cancer Genitourinary Cancers