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

Not Applicable

Completed

• Conditions: Prostate Carcinoma
• Interventions: 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

• Registration Number: NCT02704377
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Study Start: 2016-05-08
• Primary Completion: 2017-08-01
• Study Completion: 2023-04-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (quality of life, supportive care preferences)	Dual X-ray Absorptiometry	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.
Supportive care (quality of life, supportive care preferences)	Laboratory Biomarker Analysis	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.
Supportive care (quality of life, supportive care preferences)	Undergo HRV and wear accelerometer to assess therapy complications	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.
Supportive care (quality of life, supportive care preferences)	Quality-of-Life Assessment	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.
Supportive care (quality of life, supportive care preferences)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Psychological resiliency measured by Connor Davidson Resiliency Scale	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.
Explore whether heart rate variability is associated with the SF-36 and Connor Davidson Resiliency Scale.	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.
Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States