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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Carcinoma

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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (quality of life, supportive care preferences)<br>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. | Other: Undergo HRV and wear accelerometer to assess therapy complications<br>* Wear accelerometer undergo 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<br>Procedure: Dual X-ray Absorptiometry<br>* Undergo iDXA<br>* Other names: DXA SCAN;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36 | Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial. | Baseline | 
| Psychological resiliency measured by Connor Davidson Resiliency Scale | The relationship with self-reported measures of quality of life and stress will be determined. Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial. | Baseline | 
| Explore whether heart rate variability is associated with the SF-36 and Connor Davidson Resiliency Scale. | Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial. | Up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer Survivor