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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704377
• Other study ID #: OSU-15049
• Secondary ID: NCI-2015-01289
• Status: Completed
• Phase: N/A
• Start date: May 8, 2016
• Est. completion date: April 6, 2023

Study information

• Verified date: September 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 6, 2023
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

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:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

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