Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
NCT ID: NCT02704377
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2016-05-08
2023-04-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (quality of life, supportive care preferences)
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.
Undergo HRV and wear accelerometer to assess therapy complications
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
Dual X-ray Absorptiometry
Undergo iDXA
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Undergo HRV and wear accelerometer to assess therapy complications
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
Dual X-ray Absorptiometry
Undergo iDXA
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
MALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Brian Focht
Principal Investigator
Principal Investigators
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Brian Focht, PhD, FACSM
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2015-01289
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-15049
Identifier Type: -
Identifier Source: org_study_id
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