Clinical trial NCT02704377: Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
Official title: Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Carcinoma
Keywords: Prostate Cancer Survivor
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 6
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36
timeFrame: Baseline
measure: Psychological resiliency measured by Connor Davidson Resiliency Scale
timeFrame: Baseline
measure: Explore whether heart rate variability is associated with the SF-36 and Connor Davidson Resiliency Scale.
timeFrame: Up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Brian Focht, PhD, FACSM
role: PRINCIPAL_INVESTIGATOR
References: