Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Weight Loss

Body Weight

Breast Diseases

Skin Diseases

Participants will take part in supervised exercise and home-based exercise sessions. Participants will be asked to follow a specific diet. Participants will be asked to take part in weekly behavioral group phone calls.

Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.

Supervised Exercise

Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.

Home-based Exercise

Once weekly phone calls that are group-based. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.

Group Phone Calls

Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.

Diet

Carol Fabian, MD

The purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..

Feasibility will be assessed by 1) the number of women that complete the 3--month program; 2) the number of women that can achieve the targeted amount of physical activity per week by the end of the program; and 3) the median amount of physical activity achieved group by all subjects that complete the program.

Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors

Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors

Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.

Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.

Defined as number of participants attending at least 75% of the weekly group calls.

University of Kansas Medical Center

Professor, Director Breast Cancer Prevention Unit

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Prostatic Neoplasms

Obesity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.

Participants will receive a standardized educational flyer about a healthy diet and exercise.

Program involves one-on-one coaching, diet meal plan, and physical activity plan.

Weight Loss Program

The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.

Standardized educational flyer

Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.

Weight Maintenance Program

Jill Hamilton-Reeves, PhD

The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.

Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy

Impact will be measured by changes in specific blood immune biomarker biomarkers.

Impact will be measured by changes in specific blood inflammation biomarkers.

Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA).

Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life.

American Cancer Society, Inc.

Body Weight Changes

Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.

Participants will include women at high risk of breast cancer who take part in a weight loss intervention program. The intervention is the same for all participants.

Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.

Reduced Energy Diet

Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.

The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who are undergoing moderate calorie restriction.

All subjects participate in same intervention. Intervention consists of a 6-month structured weight loss program utilizing portion controlled meals and a prescribed level of graduated physical activity with an eventual goal of 200 minutes or more per week. The program will include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions the first 3 months with transition to unsupervised exercise and less frequent group phone sessions the second 3 months.

High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women

High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women

Weight Gain

Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.

All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.

Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.

Standard of Care for this patient population.

Standard of Care

Jill Hamilton-Reeves, PhD, RD, LD

The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.

The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:

1. Diet
2. Physical activity
3. Coaching
4. Diet and exercise monitoring tool

The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.

Energy Balance for Prostate Cancer Survivorship

Changes will be measured by analyzing results from alternative healthy eating index scores.

Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors	NCT02963740	Breast Cancer F...	Supervised Exer... Home-based Exer... Group Phone Cal... Diet	- 71 Years	University of Kansas Medical Center
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors	NCT02963740	Breast Cancer F...	Supervised Exer... Home-based Exer... Group Phone Cal... Diet	- 71 Years	University of Kansas Medical Center
Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy	NCT03261271	Obesity Prostate Cancer	Weight Loss Pro... Standardized ed... Weight Maintena...	50 Years -	University of Kansas Medical Center
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors	NCT02963740	Breast Cancer F...	Supervised Exer... Home-based Exer... Group Phone Cal... Diet	- 71 Years	University of Kansas Medical Center
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women	NCT03270111	Breast Cancer F...	Supervised Exer... Home-based Exer... Reduced Energy ... Group Phone Cal...	50 Years - 70 Years	University of Kansas Medical Center
Energy Balance for Prostate Cancer Survivorship	NCT02252484	Prostate Cancer	Weight Loss Pro... Standard of Car...	50 Years - 72 Years	University of Kansas Medical Center

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