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

September 14, 2023 updated by: Brian Focht, Ohio State University Comprehensive Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional 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)
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: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: 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
Procedure: Dual X-ray Absorptiometry
Undergo iDXA
Other Names:
  • DEXA
  • DXA
  • DEXA scan
  • BMD scan
  • bone mineral density scan
  • dual energy x-ray absorptiometric scan
  • Dual Energy X-ray Absorptiometry
  • Dual X-Ray Absorptometry
  • DXA SCAN

What is the study measuring?

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
Time Frame: Baseline
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
Time Frame: Baseline
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.
Time Frame: Up to 1 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Brian Focht, PhD, FACSM, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimated)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-15049
  • NCI-2015-01289 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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