Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
Primary Purpose
Prostate Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Undergo HRV and wear accelerometer to assess therapy complications
Dual X-ray Absorptiometry
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Carcinoma focused on measuring Prostate Cancer Survivor
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
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (quality of life, supportive care preferences)
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02704377
First Posted
August 31, 2015
Last Updated
September 14, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02704377
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
April 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma
Keywords
Prostate Cancer Survivor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (quality of life, supportive care preferences)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Undergo HRV and wear accelerometer to assess therapy complications
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Dual X-ray Absorptiometry
Other Intervention Name(s)
BMD scan, bone mineral density scan, DEXA, DEXA scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN
Intervention Description
Undergo iDXA
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36
Description
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.
Time Frame
Baseline
Title
Psychological resiliency measured by Connor Davidson Resiliency Scale
Description
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.
Time Frame
Baseline
Title
Explore whether heart rate variability is associated with the SF-36 and Connor Davidson Resiliency Scale.
Description
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.
Time Frame
Up to 1 week
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Focht, PhD, FACSM
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
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Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
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