Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
1 other identifier
interventional
11
1 country
1
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJanuary 25, 2022
January 1, 2022
4 months
November 10, 2016
January 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to supervised exercise sessions
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
Week 12
Secondary Outcomes (2)
Percent participants meeting physical activity goal
Week 9 to Week 12
Compliance with group telephone sessions
Week 12
Study Arms (1)
Weight Loss Intervention Group
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (1)
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.
PMID: 34638355RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol Fabian, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director Breast Cancer Prevention Unit
Study Record Dates
First Submitted
November 10, 2016
First Posted
November 15, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
January 25, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share