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

Primary Purpose

Breast Cancer Female

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Supervised Exercise

Home-based Exercise

Group Phone Calls

Diet

About this trial

This is an interventional prevention trial for Breast Cancer Female focused on measuring breast cancer survivor, weight loss program

Eligibility Criteria

undefined - 71 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women < age 71 in good general health.
Prior diagnosis of breast cancer.
At least 3 months from completion of any cytotoxic chemotherapy or radiation or surgery. May continue to take endocrine therapy and/or maintenance trastuzumab.
Body Mass Index (BMI) 30-45 kg/m2.
By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface.
Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel.
Live in the greater Kansas City Metropolitan Area
Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months.
Willing to perform unsupervised home exercise for the entire 3 months.
Willing to participate in a weekly behavioral modification group phone call for 3 months.
Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal and track food intake and exercise.

Exclusion Criteria:

Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks
Individuals with prior bariatric surgery procedures
Need for chronic immunosuppressive drugs
Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event.
Currently receiving investigational agents in a clinical trial.

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight Loss Intervention Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Adherence to supervised exercise sessions

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

Secondary Outcome Measures

Percent participants meeting physical activity goal

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

Compliance with group telephone sessions

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

Full Information

NCT ID

NCT02963740

First Posted

November 10, 2016

Last Updated

January 9, 2022

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02963740

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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..

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female

Keywords

breast cancer survivor, weight loss program

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight Loss Intervention Group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Supervised Exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Home-based Exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Group Phone Calls

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Adherence to supervised exercise sessions

Description

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

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percent participants meeting physical activity goal

Description

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

Time Frame

Week 9 to Week 12

Title

Compliance with group telephone sessions

Description

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

Time Frame

Week 12

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

71 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women < age 71 in good general health. Prior diagnosis of breast cancer. At least 3 months from completion of any cytotoxic chemotherapy or radiation or surgery. May continue to take endocrine therapy and/or maintenance trastuzumab. Body Mass Index (BMI) 30-45 kg/m2. By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface. Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel. Live in the greater Kansas City Metropolitan Area Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months. Willing to perform unsupervised home exercise for the entire 3 months. Willing to participate in a weekly behavioral modification group phone call for 3 months. Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal and track food intake and exercise. Exclusion Criteria: Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks Individuals with prior bariatric surgery procedures Need for chronic immunosuppressive drugs Participation within the past 6 months on a structured weight loss program such as Weight Watchers® Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week. Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event. Currently receiving investigational agents in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol Fabian, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34638355

Citation

Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.

Results Reference

result

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

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