Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01653366
First received: July 19, 2012
Last updated: June 5, 2014
Last verified: June 2012
  Purpose

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.


Condition Intervention
Metastatic Breast Cancer
Behavioral: Physical Activity Goal Setting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    goal-setting intervention versus standard of care: Time to progression

  • Change in Body Mass Index (BMI) [ Time Frame: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    As measured by questionnaires: FACIT-F and diet survey

  • Correlative Science outcomes in peripheral blood [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    serum estradiol and fasting insulin levels

  • Correlative science outcomes in tissue biopsies [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine the proportion of participants who are able to achieve greater than or equal to 22,500 steps/week


Estimated Enrollment: 35
Study Start Date: December 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A-Pedometer and Goal setting

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.

Behavioral: Physical Activity Goal Setting
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.
No Intervention: ARM B
Patients receive standard physical activity recommendations and follow up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653366

Contacts
Contact: Mary Chamberlin, MD 800-639-6918 Cancer.Research.Nurse@Dartmouth.edu

Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Mary Chamberlin, MD    800-639-6918    Cancer.Research.Nurse@Dartmouth.edu   
Principal Investigator: Mary Chamberlin, MD         
Sub-Investigator: Bradley Arrick, MD         
Sub-Investigator: Gary Schwartz, MD         
Sub-Investigator: Peter Kaufman, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Mary Chamberlin, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01653366     History of Changes
Other Study ID Numbers: D11282
Study First Received: July 19, 2012
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014