Clinical trial NCT01653366: 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
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in physical activity as a result of a goal setting intervention using pedometer data and exercise logs.
timeFrame: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months
Secondary outcomes:
measure: Secondary objectives: Time to progression
timeFrame: baseline, 6 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 2 month, 3 month, 4 month, 5 month, 6 months
measure: Health related quality of life
timeFrame: baseline, 6 months
measure: Correlative Science outcomes in peripheral blood
timeFrame: baseline, 6 months
measure: Correlative science outcomes in tissue biopsies
timeFrame: baseline, 6 months
measure: correlative science in >= 22500 steps
timeFrame: baseline, 6 months
measure: participants who achieve >= 22500 steps/week
timeFrame: 6 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Mary Chamberlin, MD
role: PRINCIPAL_INVESTIGATOR
References: