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

NCT02704377 | Completed DMC

• 2 other identifiers: OSU-15049NCI-2015-01289
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma

Keywords

Prostate Cancer Survivor

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Supportive care (quality of life, supportive care preferences)

EXPERIMENTAL

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; Procedure: Dual X-ray Absorptiometry; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Undergo HRV and wear accelerometer to assess therapy complications OTHER

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

Supportive care (quality of life, supportive care preferences)

Dual X-ray Absorptiometry PROCEDURE

Undergo iDXA

Also known as: 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

Supportive care (quality of life, supportive care preferences)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive care (quality of life, supportive care preferences)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (quality of life, supportive care preferences)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (quality of life, supportive care preferences)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Brian Focht, PhD, FACSM

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: March 10, 2016
• Study Start: May 8, 2016
• Primary Completion: August 1, 2017
• Study Completion: April 6, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

US (1)