Breast CancerNCT02677857
Developing a Healthy Lifestyle in Breast Cancer Survivors
A study testing Common intervention components for Lifestyle in people with Breast Cancer and Sedentary Lifestyle, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Sedentary Lifestyle
- What is being tested?
- Common intervention components for Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 65 yrs
- BMI between 25 and 45 kg/m2
- history of breast cancer (stages I [> 1 cm], II, or III) diagnosed within the previous 5 years
- completion of initial therapies
- engage in > 8 hours a day of SB
- engage in < 100 min/wk MVPA.
Who cannot join
- 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)
- report being unable to walk for 2 blocks (1/4 mile) without stopping
- report major psychiatric diseases or organic brain syndromes
- report a serious medical condition in which weight loss is contraindicated
- 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
- have had bariatric surgery or are planning to have bariatric surgery in the next 6 months
Show all 13Show fewer
- are participating in a program to increase physical activity and/or decrease sedentary time
- intend to move outside of the metropolitan area within the time frame of the investigation
- are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation
- are unwilling to attend sessions and/or unwilling to be randomized to any treatment condition;
- do not own a smartphone that will run the app required for the Polar® Loop device;
- are unwilling to use MyFitnessPal or the Polar® Loop device app for smartphones; or
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37996
About this study
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:
- lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk);
- lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to > 200 min/wk and reduce SB by 2 hrs/day); or
- 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.
- Conditions
- Breast Cancer, Sedentary Lifestyle
- Being tested
- Common intervention components for Lifestyle
- Medical subject headings
- Breast Neoplasms, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common intervention components for LifestyleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle | Active comparator | 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. Receives: Behavioral: Common intervention components for Lifestyle |
| Lifestyle + SB | Active comparator | 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. Receives: Behavioral: Common intervention components for Lifestyle |
| Newsletter | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Measures of activity by Armband
Participants will wear the SenseWear Armband (SWA) for data collection of time spent engaging in physical activity per day.
Measured: change from baseline to 12 weeks
Weight
Weight will be assessed by an electronic scale.
Measured: change from baseline to 12 weeks
Measures of diet
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.
Measured: change from baseline to 12 weeks
Fitness (The 6 Minute Walk Test (6MWT))
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.
Measured: change from baseline to 12 weeks
Physical activity by Questionnaire
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.
Measured: change from baseline to 12 weeks
Insulin
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Measured: change from baseline to 12 weeks
Glucose
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Measured: change from baseline to 12 weeks
Leptin
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Measured: change from baseline to 12 weeks
C-Reactive Protein
Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures.
Measured: change from baseline to 12 weeks
Height
Height will be assessed using a stadiometer at baseline
Measured: baseline
BMI
BMI (kg/m2) will be calculated from height and weight measurements.
Measured: change from baseline to 12 weeks
Waist circumference
waist measurement
Measured: change from baseline to 12 weeks
Percent body fat
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
Measured: change from baseline to 12 weeks
Secondary outcomes (1)
Completion of self-monitoring records
Number of weekly records of self-monitoring of diet and activity completed and turned in.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Recruitment efforts were not effective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie Raynor, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677857
- Sponsor's protocol ID
- UTKIRB-15-02602-FB
- Status last verified
- Apr 2018
- First submitted
- 25 Jan 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Healthy Lifestyle in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02677857
- Acronym / sponsor ID
- UTKIRB-15-02602-FB
- Conditions
- Breast Cancer, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment efforts were not effective.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk);
- lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to > 200 min/wk and reduce SB by 2 hrs/day); or
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle | Active comparator | Behavioral: Common intervention components for LifestyleParticipants 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. |
| Lifestyle + SB | Active comparator | Behavioral: Common intervention components for LifestyleParticipants 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. |
| Newsletter | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age between 18 and 65 yrs
- BMI between 25 and 45 kg/m2
- history of breast cancer (stages I [> 1 cm], II, or III) diagnosed within the previous 5 years
- completion of initial therapies
- engage in > 8 hours a day of SB
Key exclusion criteria (13 listed)
- 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)
- report being unable to walk for 2 blocks (1/4 mile) without stopping
- report major psychiatric diseases or organic brain syndromes
- report a serious medical condition in which weight loss is contraindicated
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common intervention components for LifestyleParticipants 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. | Behavioural | Lifestyle, Lifestyle + SB |
Primary outcome
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.
Weight
Time frame: change from baseline to 12 weeks
Weight will be assessed by an electronic scale.
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.
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.
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.
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.
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.
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.
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.
Height
Time frame: baseline
Height will be assessed using a stadiometer at baseline
BMI
Time frame: change from baseline to 12 weeks
BMI (kg/m2) will be calculated from height and weight measurements.
Waist circumference
Time frame: change from baseline to 12 weeks
waist measurement
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
1 secondary outcome
Completion of self-monitoring records
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Recruitment efforts were not effective.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollie Raynor principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common intervention components for Lifestyle in people with Breast Cancer and Sedentary Lifestyle, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment efforts were not effective.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of activity by Armband (time frame: change from baseline to 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.