Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/2/2019 |
| Start Date: | January 2, 2018 |
| End Date: | June 30, 2019 |
The Study will examine the feasibility and acceptability of a randomized trial in 40 women
with clinically stable MBC to participate in a cognitive behavioral lifestyle intervention
based on the American Cancer Society's (ACS) cancer survivorship guidelines for nutrition and
physical activity. The Investigator will use dual-energy x-ray absorptiometry or DXA to
document intervention effects on body composition; and the Investigator will also examine
patient reported outcomes, mitochondrial function and biomarkers of prognosis/survival.
with clinically stable MBC to participate in a cognitive behavioral lifestyle intervention
based on the American Cancer Society's (ACS) cancer survivorship guidelines for nutrition and
physical activity. The Investigator will use dual-energy x-ray absorptiometry or DXA to
document intervention effects on body composition; and the Investigator will also examine
patient reported outcomes, mitochondrial function and biomarkers of prognosis/survival.
Aims/Objectives
Aim 1. To examine the feasibility and acceptability of a 12 week cognitive-behavioral
lifestyle intervention, assessing rates of study eligibility, accrual, adherence, and
attrition.
Aim 2. To examine the impact of a 12-week lifestyle intervention on body composition, the
associations with serum biomarkers of prognosis and survival, and patient reported outcomes.
Hypothesis 1: Increases in LST with or without decreases in adipose tissue [measured by dual
energy x-ray absorptiometry (DXA)] will be associated with improvements in the serum
biomarkers of BC prognosis and survival [inflammatory markers (e.g., C-reactive protein
(CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6)]; cytokines (e.g., leptin,
adiponectin); insulin resistance (e.g., insulin, glucose)].
Hypothesis 2: Increases in LST with or without decreases in adipose tissue will be associated
with improvements in symptom burden and quality of life.
Exploratory Aim
Aim 3. To explore the effect of a 12-week lifestyle intervention on mitochondrial function
and its association with symptom burden.
Aim 1. To examine the feasibility and acceptability of a 12 week cognitive-behavioral
lifestyle intervention, assessing rates of study eligibility, accrual, adherence, and
attrition.
Aim 2. To examine the impact of a 12-week lifestyle intervention on body composition, the
associations with serum biomarkers of prognosis and survival, and patient reported outcomes.
Hypothesis 1: Increases in LST with or without decreases in adipose tissue [measured by dual
energy x-ray absorptiometry (DXA)] will be associated with improvements in the serum
biomarkers of BC prognosis and survival [inflammatory markers (e.g., C-reactive protein
(CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6)]; cytokines (e.g., leptin,
adiponectin); insulin resistance (e.g., insulin, glucose)].
Hypothesis 2: Increases in LST with or without decreases in adipose tissue will be associated
with improvements in symptom burden and quality of life.
Exploratory Aim
Aim 3. To explore the effect of a 12-week lifestyle intervention on mitochondrial function
and its association with symptom burden.
Inclusion Criteria:
- Adult (≥ 18 years), female
- Confirmed Metastatic Breast Cancer
- Patients clinically stable with treated brain metastases are eligible
- Written documentation from their oncologist permitting study participation
- Determined to be "clinically stable" by their medical oncologist (i.e., no
unintentional weight loss, no new symptoms or change in performance status for the
past 4 weeks, no clinical [including laboratory] or radiologic evidence of disease
progression, no recent or planned change in anti-neoplastic therapies, no reports of
severe pain [≥ Grade 3 per the NCI CTCAE)
- Life expectancy >6 months
- Access to a mobile phone
- Understand/speak English fluently.
- Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented
by questionnaire.
Exclusion Criteria:
- Does not meet the above criteria.
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