Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.

For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.

Exercise

Celina Shirazipour, PhD

This is a single-arm pilot study to evaluate the use of web-based video conferencing as a method of exercise training delivery. This study will include 10 female breast cancer survivors and 10 male prostate cancer survivors. For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.

Streaming Web-based Exercise At Home: A Pilot Study

IIT2019-14-SHIRAZIP-SWEAT: Streaming Web-based Exercise At Home: A Pilot Study

Explore adherence to intervention delivery measured through attendance (frequency of Skype sessions attended and fully completed)

Explore adherence to intervention delivery measured through retention (participation from baseline through final assessment)

Explore adherence to intervention delivery measured through percentage of patients approached who sign consent

Explore adherence to intervention delivery measured through scores on manipulation check after each session (2 questions asked by exercise physiologist on sound and visual clarity of the session)

Change in vO2 submax measurement (rate of oxygen uptake during exercise) between baseline \& mid-study visits as measured by Bruce submaximal treadmill test.

Change in vO2 submax measurement (rate of oxygen uptake during exercise) between mid-study \& end of study visits as measured by Bruce submaximal treadmill test.

Change in vO2 submax measurement (rate of oxygen uptake during exercise) between baseline \& end of study visits as measured by Bruce submaximal treadmill test.

Change in muscle strength measurement between baseline \& mid-study visits as measured by grip strength test and leg press.

Change in muscle strength measurement between mid-study \& end of study visits as measured by grip strength test and leg press.

Change in muscle strength measurement between baseline \& end of study visits as measured by grip strength test and leg press.

Changes in resting heart rate between Baseline \& mid-study visits

Changes in resting heart rate between mid-study \& end of study visits

Changes in resting heart rate between Baseline \& end of study visits

Changes in body composition between baseline \& mid-study visits as measured by InBody (non-invasive body composition analysis that calculates weight, skeletal muscle mass, fat mass, BMI, and body fat percent using Bio-Electrical Impedance Analysis).

Changes in body composition between mid-study \& end of study visits as measured by InBody (non-invasive body composition analysis that calculates weight, skeletal muscle mass, fat mass, BMI, and body fat percent using Bio-Electrical Impedance Analysis).

Change in body composition between baseline \& end of study visits as measured by InBody (non-invasive body composition analysis that calculates weight, skeletal muscle mass, fat mass, BMI, and body fat percent using Bio-Electrical Impedance Analysis).

Subjective impact of exercise intervention as measured by changes in participant-reported rating of exercise self-efficacy and intentions to remain active

Celina Shirazipour

Assistant Professor

Behaviors and Mental Disorders

Carcinoma

Quality of Life

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.

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

Undergo HRV and wear accelerometer to assess therapy complications

Dual X-ray Absorptiometry

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Questionnaire Administration

Brian Focht, PhD, FACSM

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.

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.

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Streaming Web-based Exercise At Home: A Pilot Study	NCT04282967	Prostate Cancer Breast Cancer F...	Exercise	18 Years -	Cedars-Sinai Medical Center
Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors	NCT02704377	Prostate Carcin...	Undergo HRV and... Dual X-ray Abso... Laboratory Biom... Quality-of-Life... Questionnaire A...	-	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for prostate cancer survivor