Developing a Healthy Lifestyle in Breast Cancer Survivors

April 3, 2018 updated by: Hollie Raynor, The University of Tennessee, Knoxville

At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to randomize 30 female breast cancer survivors (history of breast cancer stages I [> 1 cm], II, or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in > 8 hours a day of SB) and inactive (engage in < 100 min/wk MVPA) to one of three, 3-month conditions:

  1. lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk);
  2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to > 200 min/wk and reduce SB by 2 hrs/day); or
  3. weight management education materials provided via mailed newsletter (Newsletter).

Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie [1200-1500 kcal/day], low-fat [<30% calories from fat]) prescription that emphasizes intake of fruits, vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting activity and diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis that have been found to be positively related to SB and/or adiposity); diet; body composition; and fitness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Healthy Eating and Activity Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. age between 18 and 65 yrs
  2. BMI between 25 and 45 kg/m2
  3. history of breast cancer (stages I [> 1 cm], II, or III) diagnosed within the previous 5 years
  4. completion of initial therapies
  5. engage in > 8 hours a day of SB
  6. engage in < 100 min/wk MVPA.

Exclusion Criteria:

  1. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)25 (The Health Screening Questionnaire will also be used to identify individuals with joint problems, prescription medication usage, or other medical conditions that could limit exercise, and these individuals will be required to obtain written physician consent to participate - the two questionnaires are found in questions 4-11 in the phone screen in Appendix B)
  2. report being unable to walk for 2 blocks (1/4 mile) without stopping
  3. report major psychiatric diseases or organic brain syndromes
  4. report a serious medical condition in which weight loss is contraindicated
  5. are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months
  6. have had bariatric surgery or are planning to have bariatric surgery in the next 6 months
  7. are participating in a program to increase physical activity and/or decrease sedentary time
  8. intend to move outside of the metropolitan area within the time frame of the investigation
  9. are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation
  10. are unwilling to attend sessions and/or unwilling to be randomized to any treatment condition;
  11. do not own a smartphone that will run the app required for the Polar® Loop device;
  12. are unwilling to use MyFitnessPal or the Polar® Loop device app for smartphones; or
  13. have a metal allergy or are not able to wear anything on an upper arm (which would prevent the ability of participant to wear the SenseWear® armband from BodyMedia® used in the proposed study).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lifestyle
Participants will be educated on the relationship between MVPA and improved health outcomes, including weight management, and cancer survivorship. The goal will be to increase MVPA to > 40 min/day 5 times/wk As participants will be overweight/obese, inactive, and coming into the program with different levels of baseline fitness and time since last cancer treatment, participants will shape their MVPA to meet the targeted goals. Initially, participants will be encouraged to complete MVPA > 10 min/day 5 times/wk, and then progressively increase MVPA by 5 min/day every week until reaching the intervention goal (week 7 of the 12 week intervention). Participants will be encouraged to do brisk walking and be allowed to accumulate time spent being physically active by engaging in multiple short bouts (i.e., > 10 min in length). Any MVPA in bouts of > 10 min in length will be counted towards the MVPA goal. Participants will self-monitor their MVPA using the Polar® Loop tracking system.
Behavioral: Common intervention components for Lifestyle
Participants in these conditions will receive standard care and one of the Lifestyle conditions. There are several components that will be identical for both Lifestyle conditions. These components include treatment structure, dietary goals, and cognitive behavioral strategies.
Active Comparator: Lifestyle + SB
Participants will receive everything that is described in Lifestyle. Additionally, they will be educated on the relationship between SB and weight management, and cancer survivorship risk. The goal will be to reduce sedentary time by > 2 hrs/day or > 14 hrs/wk. Participants will shape towards the goal. Baseline measures will be used as the starting point from where to calculate the 2 hrs/day reduction, providing participants with a total SB goal per day. For example, if baseline measures indicate that a participant has a mean daily SB amount of 9.75 hrs, the participant's SB goal will be 7.75 hrs/day. To achieve that goal, participants will reduce SB by 20 minutes a day, starting week 2, with a decrease of an additional 20 minutes/day occurring weekly until the SB goal is achieved (week 7 of the 12 week intervention. Participants will self-monitor their SB using the Polar® Loop tracking system.
Behavioral: Common intervention components for Lifestyle
Participants in these conditions will receive standard care and one of the Lifestyle conditions. There are several components that will be identical for both Lifestyle conditions. These components include treatment structure, dietary goals, and cognitive behavioral strategies.
No Intervention: Newsletter
Participants in this condition will receive standard care and every month they will receive a newsletter that provides information and tips about healthy eating and activity behaviors. This newsletter will include information on myPlate,28 activity guidelines,29 reading food labels, healthy recipes, and seasonal activity suggestions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measures of activity by Armband
Time Frame: change from baseline to 12 weeks
Participants will wear the SenseWear Armband (SWA) for data collection of time spent engaging in physical activity per day.
change from baseline to 12 weeks
Weight
Time Frame: change from baseline to 12 weeks
Weight will be assessed by an electronic scale.
change from baseline to 12 weeks
Measures of diet
Time Frame: change from baseline to 12 weeks
Diet will be assessed by 3-day food records (2 weekdays and 1 weekend day). Each record will be completed using the Nutrition Data System Software for Research (NDS-R) developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
change from baseline to 12 weeks
Fitness (The 6 Minute Walk Test (6MWT))
Time Frame: change from baseline to 12 weeks
The 6 Minute Walk Test (6MWT) is well tolerated by participants who are obese. Participants will walk as quickly as possible, without jogging or running, around two cones placed 60 m apart for 6 min. The primary measure will be distance walked. The 6MWT has been significantly correlated to peak oxygen uptake (VO2) values from a cycle ergometer test (r = .73, p < 0.001). The 6MWT has been shown to measure enhanced physical performance beyond that which occurs from weight loss itself in participants with obesity. Standard safety protocols will be used for participants that Dr. Bell considers appropriate for testing.
change from baseline to 12 weeks
Physical activity by Questionnaire
Time Frame: change from baseline to 12 weeks
Participants will complete the Past-day Adults' Sedentary Time (PAST), a seven-item questionnaire that asks questions about sedentary behaviors that have occurred during the previous day.
change from baseline to 12 weeks
Insulin
Time Frame: change from baseline to 12 weeks
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
change from baseline to 12 weeks
Glucose
Time Frame: change from baseline to 12 weeks
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
change from baseline to 12 weeks
Leptin
Time Frame: change from baseline to 12 weeks
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
change from baseline to 12 weeks
C-Reactive Protein
Time Frame: change from baseline to 12 weeks
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
change from baseline to 12 weeks
Height
Time Frame: baseline
Height will be assessed using a stadiometer at baseline
baseline
BMI
Time Frame: change from baseline to 12 weeks
BMI (kg/m2) will be calculated from height and weight measurements.
change from baseline to 12 weeks
Waist circumference
Time Frame: change from baseline to 12 weeks
waist measurement
change from baseline to 12 weeks
Percent body fat
Time Frame: change from baseline to 12 weeks
Percent body fat will be assessed by bioelectrical impedance analysis (BIA), using the foot to foot pressure contact electrode BIA technique (Tanita TBF-300A model) following standard protocol
change from baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Completion of self-monitoring records
Time Frame: 12 weeks
Number of weekly records of self-monitoring of diet and activity completed and turned in.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Tennessee, Knoxville

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hollie Raynor, University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UTKIRB-15-02602-FB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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