Breast Cancer FemaleNCT02963740
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
A study testing Supervised Exercise, Home-based Exercise and Group Phone Calls in people with Breast Cancer Female, run by University of Kansas Medical Center at 1 site in United States.
Trial 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.. Read more about this study
- Who is it for?
- Ages Up to 71 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Supervised Exercise, Home-based Exercise and Group Phone Calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Mar 2017
- 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 Up to 71 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors
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..
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- Supervised Exercise, Home-based Exercise, Group Phone Calls, Diet
- Keywords
- breast cancer survivor, weight loss program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised ExerciseBehavioural
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.
Home-based ExerciseBehavioural
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.
Group Phone CallsBehavioural
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.
DietBehavioural
Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Intervention Group | Experimental | 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. Receives: Behavioral: Supervised Exercise; Behavioral: Home-based Exercise; Behavioral: Group Phone Calls; Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to supervised exercise sessions
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
Measured: Week 12
Secondary outcomes (2)
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.
Measured: Week 9 to Week 12
Compliance with group telephone sessions
Defined as number of participants attending at least 75% of the weekly group calls.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963740
- Sponsor's protocol ID
- STUDY00004575
- Status last verified
- Jan 2022
- First submitted
- 10 Nov 2016
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34638355
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02963740
- Acronym / sponsor ID
- STUDY00004575
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer survivor, weight loss program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Nov 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Intervention Group | Experimental | Behavioral: Supervised Exercise, Behavioral: Home-based Exercise, Behavioral: Group Phone Calls, Behavioral: DietParticipants 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. |
Who may qualify
- Ages
- Up to 71 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Supervised ExerciseParticipants 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. | Behavioural | Weight Loss Intervention Group |
| Home-based ExerciseAerobic 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. | Behavioural | Weight Loss Intervention Group |
| Group Phone CallsOnce 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. | Behavioural | Weight Loss Intervention Group |
| DietParticipants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics. | Behavioural | Weight Loss Intervention Group |
Primary outcome
Adherence to supervised exercise sessions
Time frame: Week 12
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
2 secondary outcomes
Percent participants meeting physical activity goal
Time frame: Week 9 to Week 12
Compliance with group telephone sessions
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Results publication: PubMed 34638355Fabian 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.
- Individual participant dataSharing planned: No
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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.
Carol Fabian, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise, Home-based Exercise and Group Phone Calls in people with Breast Cancer Female, run by University of Kansas Medical Center 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 25 Jan 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to supervised exercise sessions (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963740, which also lists 1 linked publication.
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 25 Jan 2022.