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

The Ohio State University

Status: Completed

Conditions: Prostate Carcinoma

Treatments: Procedure: Dual X-ray Absorptiometry; Other: Undergo HRV and wear accelerometer to assess therapy complications; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02704377

OSU-15049

NCI-2015-01289 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Supportive care (quality of life, supportive care preferences)

Experimental group

Description:

Participants complete questionnaires about quality of life and preferences for supportive care treatment, wear accelerometerundergo heart rate variability(HRV) 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 Dual X-ray Absorptiometry (iDXA) scan over 10 minutes. Other interventions include: Laboratory Biomarker Analysis, Quality-of-Life Assessments, and othe Questionnaire Administration.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Laboratory Biomarker Analysis

Other: Undergo HRV and wear accelerometer to assess therapy complications

Procedure: Dual X-ray Absorptiometry