Metastatic Breast CancerNCT01653366
Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway
A study testing Physical Activity Goal Setting in people with Metastatic Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study is a randomized prospective clinical trial of women with metastatic breast cancer. The purpose of the study is to test if an intervention of regular physical activity review and physical activity goal setting will allow the subjects to achieve a moderate increase in physical activity of 6,000 steps per… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Physical Activity Goal Setting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with measurable per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 and biopsy-able (as determined by Co-Investigator John Gemery, MD) metastatic carcinoma of the breast.
- Physically able to undertake a moderate physical activity program.
- Greater than 4 weeks from any radiation treatments for metastatic disease.
- standard of care biopsy must occur within 30 days of registration.
- Able to follow directions and fill out questionnaires and physical activity diaries in English.
- Willing to consent to biopsies and be randomly assigned to one of two study arms which may or may not include physical activity goal setting.
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- Consents to be contacted via phone or internet (see Appendix K).
- No to all questions on Physical Activity Readiness Questionnaire (see appendix A) or approved by primary oncologist or other care provider provider for participation.
- Hb >10 without transfusion, liver function tests less than 3 times upper limits of normal, normal thyroid-stimulating hormone (TSH), absolute neutrophil count (ANC) >1500.
- Karnofsky performance status ≥ 80%
- Previous Physical Therapy consultation and treatments acceptable.
- Participation in other trials acceptable.
- CNS disease that is treated and stable by MRI for at least 6 months
Who cannot join
- Patients less than 18 years of age.
- Patients unable to give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.
- Pregnant or nursing women.
- Patients with any untreated (CNS) disease.
- Patients with other active cancers requiring treatment.
- Patients with clotting or bleeding disorder precluding biopsy.
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- Patients with significant cardiovascular disease, including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months or serious cardiac arrhythmias will be excluded.
- Current use of supplements containing conjugated linoleic acid, or use within the 30 days preceding registration.
- Persons with a known diagnosis of diabetes are not eligible. Prior use of metformin allowable if previously enrolled on MA.32 trial as part of their adjuvant therapy for early stage breast cancer.
- Persons of male gender.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
This study is a randomized prospective clinical trial of women with metastatic breast cancer. The purpose of the study is to test if an intervention of regular physical activity review and physical activity goal setting will allow the subjects to achieve a moderate increase in physical activity of 6,000 steps per week. The physical activity review will consist of weekly telephone call to inquire about symptoms and to set physical activity goals. The study will also look to see if the goal setting intervention will affect the time to progression, change in BMI, and quality of life. Quality of life will be measured by answers to questionnaires provided to subjects at regular intervals during the course of the study. Finally, the study will examine the impact of physical activity on expression of tumor molecular molecules, insulin levels, and estradiol levels.
Through an intervention of regular physical activity review and goal setting, the investigators hypothesize that a moderate increase in level of physical activity of 6000 steps per week or more can be obtained by patients with metastatic breast cancer who receive a goal setting intervention. The investigators propose that those who are able to achieve and maintain greater than or equal to 22500 steps per week will demonstrate biologic and molecular differences compared to those who are not able to achieve that level of physical activity. The investigators expect that people who are more active will have longer to progression.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Physical Activity Goal Setting
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Goal SettingBehavioural
Will include an initial physical therapy (PTA) consult to set exercise goals to increase physical activity by 6000 steps per week over the course of the trial, viewing of the "Exercise and Breast Cancer" digital video disc (DVD, followed by 10 regular phone calls or RN visits (weekly for the first month, then monthly) to follow up on whether or not those goals are being met and, if not, how best to meet them.
| Study group | Role | What they receive |
|---|---|---|
| Arm A-Pedometer and Goal setting | Experimental | Physical Activity Goal Setting
Patients receive physical therapy (PT) consult, educational materials, and telephone calls and are contacted weekly/monthly for physical activity (PA) goal setting with registered nurse (RN). Physical Activity completed is measured with pedometers and recorded on patient log. Receives: Behavioral: Physical Activity Goal Setting |
| ARM B | No intervention | Patients receive standard physical activity recommendations and follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity as a result of a goal setting intervention using pedometer data and exercise logs.
To increase physical activity levels by at least 6000 steps/wk over 6 months using a goal setting intervention
Measured: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months
Secondary outcomes (7)
Secondary objectives: Time to progression
goal-setting intervention versus standard of care: Time to progression
Measured: baseline, 6 months
Change in Body Mass Index (BMI)
Measured: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months
Health related quality of life
As measured by questionnaires: FACIT-F and diet survey
Measured: baseline, 6 months
Correlative Science outcomes in peripheral blood
serum estradiol and fasting insulin levels
Measured: baseline, 6 months
Correlative science outcomes in tissue biopsies
relative protein expression of Lipoprotein Lipase (LPL), Cluster of Differentiation 36 (CD36), Spot 14 and fatty acid synthase (FASN) of the original tumor to the metastatic tumor at baseline and at the end of the study.
Measured: baseline, 6 months
correlative science in >= 22500 steps
Compare correlative science outcomes in those who achieve greater than or equal to 22500 steps/ week to those who do not.
Measured: baseline, 6 months
participants who achieve >= 22500 steps/week
Determine the proportion of participants who are able to achieve greater than or equal to 22,500 steps/week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: primary goal not achievable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Chamberlin, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653366
- Sponsor's protocol ID
- D11282
- Status last verified
- Jun 2012
- First submitted
- 19 Jul 2012
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway
- ClinicalTrials.gov ID
- NCT01653366
- Acronym / sponsor ID
- D11282
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: primary goal not achievable
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Jul 2012 (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.
This study is a randomized prospective clinical trial of women with metastatic breast cancer. The purpose of the study is to test if an intervention of regular physical activity review and physical activity goal setting will allow the subjects to achieve a moderate increase in physical activity of 6,000 steps per week. The physical activity review will consist of weekly telephone call to inquire about symptoms and to set physical activity goals. The study will also look to see if the goal setting intervention will affect the time to progression, change in BMI, and quality of life. Quality of life will be measured by answers to questionnaires provided to subjects at regular intervals during the course of the study. Finally, the study will examine the impact of physical activity on expression of tumor molecular molecules, insulin levels, and estradiol levels.
Through an intervention of regular physical activity review and goal setting, the investigators hypothesize that a moderate increase in level of physical activity of 6000 steps per week or more can be obtained by patients with metastatic breast cancer who receive a goal setting intervention. The investigators propose that those who are able to achieve and maintain greater than or equal to 22500 steps per week will demonstrate biologic and molecular differences compared to those who are not able to achieve that level of physical activity. The investigators expect that people who are more active will have longer to progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A-Pedometer and Goal setting | Experimental | Behavioral: Physical Activity Goal SettingPhysical Activity Goal Setting Patients receive physical therapy (PT) consult, educational materials, and telephone calls and are contacted weekly/monthly for physical activity (PA) goal setting with registered nurse (RN). Physical Activity completed is measured with pedometers and recorded on patient log. |
| ARM B | No intervention | –Patients receive standard physical activity recommendations and follow up. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with measurable per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 and biopsy-able (as determined by Co-Investigator John Gemery, MD) metastatic carcinoma of the breast.
- Physically able to undertake a moderate physical activity program.
- Greater than 4 weeks from any radiation treatments for metastatic disease.
- standard of care biopsy must occur within 30 days of registration.
- Able to follow directions and fill out questionnaires and physical activity diaries in English.
Key exclusion criteria (10 listed)
- Patients less than 18 years of age.
- Patients unable to give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.
- Pregnant or nursing women.
- Patients with any untreated (CNS) disease.
- Patients with other active cancers requiring treatment.
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 |
|---|---|---|
| Physical Activity Goal SettingWill include an initial physical therapy (PTA) consult to set exercise goals to increase physical activity by 6000 steps per week over the course of the trial, viewing of the "Exercise and Breast Cancer" digital video disc (DVD, followed by 10 regular phone calls or RN visits (weekly for the first month, then monthly) to follow up on whether or not those goals are being met and, if not, how best to meet them. | Behavioural | Arm A-Pedometer and Goal setting |
Primary outcome
Change in physical activity as a result of a goal setting intervention using pedometer data and exercise logs.
Time frame: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months
To increase physical activity levels by at least 6000 steps/wk over 6 months using a goal setting intervention
7 secondary outcomes
Secondary objectives: Time to progression
Time frame: baseline, 6 months
Change in Body Mass Index (BMI)
Time frame: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months
Health related quality of life
Time frame: baseline, 6 months
Correlative Science outcomes in peripheral blood
Time frame: baseline, 6 months
Correlative science outcomes in tissue biopsies
Time frame: baseline, 6 months
correlative science in >= 22500 steps
Time frame: baseline, 6 months
participants who achieve >= 22500 steps/week
Time frame: 6 months
Results and safety
The study was stopped early (reason given: primary goal not achievable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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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.
Mary Chamberlin, MD principal investigator
Dartmouth-Hitchcock 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 Physical Activity Goal Setting in people with Metastatic Breast Cancer, run by Dartmouth-Hitchcock 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 13 inclusion and 10 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 16 Aug 2016. 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: primary goal not achievable). 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?
Change in physical activity as a result of a goal setting intervention using pedometer data and exercise logs. (time frame: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months). 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 16 Aug 2016.