Back to resultsEffect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway
Primary Purpose
Metastatic Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Goal Setting
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Dartmouth Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm A-Pedometer and Goal setting
ARM B
Arm Description
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.
Patients receive standard physical activity recommendations and follow up.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Secondary objectives: Time to progression
goal-setting intervention versus standard of care: Time to progression
Change in Body Mass Index (BMI)
Health related quality of life
As measured by questionnaires: FACIT-F and diet survey
Correlative Science outcomes in peripheral blood
serum estradiol and fasting insulin levels
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.
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.
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
Full Information
NCT ID
NCT01653366
First Posted
July 19, 2012
Last Updated
August 15, 2016
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01653366
Brief Title
Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway
Official Title
Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
primary goal not achievable
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A-Pedometer and Goal setting
Arm Type
Experimental
Arm Description
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.
Arm Title
ARM B
Arm Type
No Intervention
Arm Description
Patients receive standard physical activity recommendations and follow up.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Goal Setting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in physical activity as a result of a goal setting intervention using pedometer data and exercise logs.
Description
To increase physical activity levels by at least 6000 steps/wk over 6 months using a goal setting intervention
Time Frame
Baseline, 2 month, 3 month, 4 month, 5 month, 6 months
Secondary Outcome Measure Information:
Title
Secondary objectives: Time to progression
Description
goal-setting intervention versus standard of care: Time to progression
Time Frame
baseline, 6 months
Title
Change in Body Mass Index (BMI)
Time Frame
Baseline, 2 month, 3 month, 4 month, 5 month, 6 months
Title
Health related quality of life
Description
As measured by questionnaires: FACIT-F and diet survey
Time Frame
baseline, 6 months
Title
Correlative Science outcomes in peripheral blood
Description
serum estradiol and fasting insulin levels
Time Frame
baseline, 6 months
Title
Correlative science outcomes in tissue biopsies
Description
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.
Time Frame
baseline, 6 months
Title
correlative science in >= 22500 steps
Description
Compare correlative science outcomes in those who achieve greater than or equal to 22500 steps/ week to those who do not.
Time Frame
baseline, 6 months
Title
participants who achieve >= 22500 steps/week
Description
Determine the proportion of participants who are able to achieve greater than or equal to 22,500 steps/week
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Chamberlin, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
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Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway
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