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

Fatigue

The patients will carry out a daily exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The patients will be supervised by medical personnel.

Supervised exercise

The patients will receive instructions about exercise and will have access to a bike ergometer to work out. However, they will not receive daily supervision or participate in a structured exercise program.

Exercise Instruction

Fernando Dimeo, MD

The study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood stem cell transplantation.

Exercise During the Allogeneic Stem Cell Transplantation

Charite University, Berlin, Germany

Dr. Fernando Dimeo

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

This is a single arm pilot study of group base exercise

The BE-BALANCED program will run for 12-weeks, with participants attending group-based virtual supervised exercise sessions twice weekly. Participants will complete an individual in-person assessment at baseline and again at end of intervention to collect physical outcome measures and will complete questionnaires electronically using REDCap, (or mailed version). Follow-up assessments will be administered electronically to each participant using REDCap at 3-months after program completion (24 weeks post-baseline).

Be-Balanced

Kelly Mackenzie

Kelly P Lab

Kristin L Campbell

This study will explore the feasibility (suitability), efficacy (research-setting outcomes), and participant satisfaction of a virtually-supervised 12-week exercise and diet intervention for women with ovarian cancer. It will include exercise, behavior change strategies, and guidance around healthy eating. Participants will be instructed and supervised virtually in two exercise sessions weekly for 12 weeks by a professional trained to deliver the program. An additional 1 exercise session per week, completed independently, will be added from weeks 4-12 of the program. Finally participants will participate in two separate virtual group nutrition sessions. Assessments will occur at baseline, end-of-intervention, and 6 months post-baseline.

Purpose: To assess the feasibility, preliminary efficacy, and patient perspectives of a 12-week supervised, virtually-delivered exercise and healthy eating program for women living with and beyond ovarian cancer.

Hypothesis: The investigators hypothesize that the program will be feasible and will demonstrate efficacy, and that patient perspectives will be overall positive and in support of the program.

Justification: Women living with and beyond ovarian cancer exercise at levels below the general population, and are at an increased risk for falls. Exercise and healthy eating programming is not a part of routine care. This project has the potential to demonstrate a feasible and relatively low-cost option for offering such programming.

Objectives: the objectives of this program are: 1) Primary Objective: To measure the feasibility of delivering the BE-BALANCED program from a virtual (i.e. live video) setting. Feasibility will be evaluated per individual item based on a priori targets; 2) Secondary Objective: To evaluate the preliminary efficacy of the BE-BALANCED program; 3) Tertiary Objective: To evaluate patient satisfaction (post-intervention only)

Research Design: This study is a prospective single-arm feasibility study.

Statistical Analysis: The primary aim is feasibility. This will be evaluated using descriptive statistics, focusing on the program recruitment, attendance, attrition, and fidelity. For secondary and tertiary/exploratory aims, a repeated measures ANOVA will be performed for each measure to evaluate the change in outcomes from baseline and end of intervention (12-weeks) and 3-month follow-up. In addition to the RM-ANOVA, an effect size for each measure will be calculated based on the same time-frame comparisons. SPSS will be used to process data.

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer (The BE-BALANCED Study)

Overall satisfaction; measured on scale 0-7 with higher score meaning higher satisfaction.

Assessed by meeting accrual targets (number recruited)

Assessed as number of supervised virtual sessions that a participant attended, out of a total of 24 group exercise sessions, and number of self-directed sessions completed, out of a total of 9 sessions.

Assessed as number of drop-outs during the 12-week program.

Group Belonging Scale (0-20; higher is better)

Measured by the gait speed portion of The Short Physical Performance Battery. Measured in seconds.

Measured by 8 foot timed up and go (Seniors Fitness Test). Measured by distance in seconds.

Measured by 30-second chair stand (Seniors Fitness Test). Measured in repetitions completed.

Measured by 30-second biceps curl (Seniors Fitness Test). Measured in repetitions completed.

Measured by Functional Reach Test. Measured in centimeters.

Measured by the Six Minute Walk test. Measured in meters.

Measured using stadiometer. Measured in meters

Measured using a scale. Measured in kilograms

Aggregated measure of height and weight, reported in kilograms/meter\^2

Measured by 36-item Short Form Health Survey; Norm-based 0-100, higher score represents better health

Measured by Hospital Anxiety and Depression Scale; Score range 0-21, higher score is higher depression and anxiety.

Measured by Modified Godin Leisure Time Physical Activity questionnaire; Scoring range 0 - no specified maximum. Scoring \< 14 units "insufficiently Active" ; 14-23 is "moderately active" and \>=24 is "active".

Measured by standard falls calendar for the duration of the study as number of falls.

British Columbia Cancer Agency

University of British Columbia

Professor

Interventiongroup, undergo supervised exercise for the first 6 weeks.

Controlgroup, do not undergo supervised exercise for the first 6 weeks (possibility to undergo supervised exercise after 6 weeks).

Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.

Hans van der Vliet, Prof.

Laurien Buffart, PhD

Marieke ten Tusscher, MSc.

Susanne van der Velde, Dr.

'Supervised exercise to PRomote Infiltration of NK-cells into the Tumor? The objective of this feasibility study is to 1) study trial feasibility in terms of patient enrollment and the percentage of tumor biopsies that can be examined successfully, and 2) generate preliminary data on the potential effects of exercise on immune function assessed in the tumor and in blood.

This is a multicenter randomized controlled feasibility trial, in which 20 women with breast cancer scheduled for neoadjuvant 2 or 3 weekly AC-T(H) chemotherapy will be randomized into a combined aerobic and resistance exercise intervention group or a usual care (no exercise) control group, during the first 6 weeks (2 or 3 cycles) of chemotherapy. Patients from the control group will receive care as usual and are requested to maintain their usual daily physical activities. In order to limit contamination (increase of exercise in the control group), non-participation and prevent dropout, the control group will be offered the same 6-week exercise intervention after the tumor biopsy has been taken after 6 weeks.

Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor

POLARIS study (PROSPERO 2013 CRD42013003805)

Percentage of patient actually enrolled in the study of all patients who will be screened

Percentage of tumor biopsies that can be examined successfully

on the potential effects of exercise on immune function (Tumor tissue will be investigated by immunohistochemistry (IHC) to assess immune cell infiltration into the tumor with a specific focus on NK-cell frequency and phenotype) assessed in the tumor and in blood.

Amsterdam UMC, location VUmc

Prof. Dr.

Blood and Lymph Conditions

Hematologic Diseases

The patients will not carry out a structured exercise program.

The patients will carry out a daily endurance exercise program consisting of walking on a treadmill for 30 minutes at an intensity of about 80% of the maximum heart rate under supervision from study personnel.

The study evaluates the effects of a supervised exercise program on the physical performance, the mood and the complications of therapy in patients undergoing a high-dose chemotherapy followed by an autologous peripheral blood stem cell transplantation.

Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

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

Behaviors and Mental Disorders

Quality of Life

The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine.

Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial

Patients randomized to the control group will also receive an activity tracker (like the intervention group). We will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.

An individualised exercise programme supervised by a trained instructor

Anne May, PhD

Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. The investigators designed the EFFECT study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage IV) on cancer-related physical fatigue, Health-Related Quality of Life (HRQoL), and other disease and treatment-related side effects at six months (primary endpoint).

The EFFECT study is a multicentre, randomised controlled trial. The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine.

Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial. Patients randomized to the control group will also receive an activity tracker (like the intervention group). The investigators will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.

Effects of Exercise in Patients With Metastatic Breast Cancer

Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life

(Serious) Adverse events potentially related to the exercise intervention

Exploratory outcome (add on in some centers) - measured with ICIQ-UI

Exploratory outcome (add on in one center) - Isokinetic and isometric legstrength measured with peak torque / Muscle thickness with ultrasound protocol

Physical fatigue measured with the EORTC QLQ-FA12

Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score

EORTC QLQ-C30 function and symptom scores scores

Common Toxicity Criteria for adverse events (CTCAE)

Bioelectrical impedance analysis (BIA), add-on in some centers (not obligatory): DEXA

Blood pressure (diastolic and systolic) measured at rest

Short Physical Performance Battery, handgrip- and leg strength test

Steep ramp test and endurance cycle test, add-on (not obligatory): CPET

Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )

Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry

The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry

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
Exercise During the Allogeneic Stem Cell Transplantation	NCT00883714	Fatigue Allogeneic Stem...	Supervised exer... Exercise Instru...	18 Years - 70 Years	Charite University, Berlin, Germany
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
Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer	NCT04911114	Ovarian Cancer	Be-Balanced	50 Years - 75 Years	University of British Columbia
Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor	NCT04704856	Breast Cancer	Supervised exer...	18 Years -	Amsterdam UMC, location VUmc
Exercise Following Autologous Peripheral Blood Stem Cell Transplantation	NCT00883961	Hematological D...	Supervised exer...	18 Years - 70 Years	Charite University, Berlin, Germany
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
Exercise Following Autologous Peripheral Blood Stem Cell Transplantation	NCT00883961	Hematological D...	Supervised exer...	18 Years - 70 Years	Charite University, Berlin, Germany
Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer	NCT04911114	Ovarian Cancer	Be-Balanced	50 Years - 75 Years	University of British Columbia
Effects of Exercise in Patients With Metastatic Breast Cancer	NCT04120298	Metastatic Brea...	Supervised exer...	18 Years -	UMC Utrecht
Exercise During the Allogeneic Stem Cell Transplantation	NCT00883714	Fatigue Allogeneic Stem...	Supervised exer... Exercise Instru...	18 Years - 70 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for supervised exercise