Breast Neoplasms
Conditions
Brief summary
The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.
Detailed description
Currently the Department of Health and Human Services, the American Cancer Society and others provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines, and also elect to delay concerted efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition and breast cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the association between lifestyle behaviors and breast cancer survival, this study will improve our knowledge of how changes in diet and physical activity influence breast cancer outcomes. Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer mortality. The proposed study will examine, in 172 women newly diagnosed with Stage I-III breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on the following breast cancer outcomes measured before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year post-diagnosis (Time 2), at two years post-diagnosis (Time 3), and at five-years post-diagnosis (Time 4): adherence to treatment, and changes in biomarkers, body composition, diet, physical activity and quality of life.
Interventions
BEHAVIORALDietary/Physical Activity intervention
Motivational counseling to follow established dietary and exercise guidelines.
BEHAVIORALUsual Care
Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Sponsors
Yale University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The following study personnel will be masked to participant study arm: the staff performing DXA scan and blood processing/biomarker evaluation. The staff performing clinic measures, study staff reviewing forms and entering data, the PI and Co-Is, the statistician, study manager, and interventionists (study dieticians) will be unblinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Stage I-III breast cancer * Scheduled to receive neoadjuvant or adjuvant chemotherapy * Physically able to walk * Able to complete forms, understand instructions and read intervention book in English * Agrees to be randomly assigned to either intervention or usual care group
Exclusion criteria
* Women who have completed their 2nd chemotherapy * Women already practicing dietary or physical activity guidelines * Are pregnant or intending to become pregnant in the next year * Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \< 40% * Presence of dementia or major psychiatric disease * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Treatment Measured by Chemotherapy Completion Rate | before initiating chemotherapy to post-chemotherapy, up to 7 months | Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose. |
| Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) | 12 months after enrollment | This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. 1. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted) 2. In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) 3. In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) |
| Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). | 24 months after enrollment | This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted- Q1) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q2) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response | At the time of surgical resection following initial course of chemotherapy | In the subset of patients receiving neoadjuvant chemotherapy, no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Data presented here is the number of participants with a pathological Complete Response. |
| Mean Insulin Level | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year | Assessed by fasting blood (fast of 12 hours or more). |
| Mean C-reactive Protein Level | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year | Assessed by fasting blood (fast of 12 hours or more). |
| Mean Body Composition-body Weight | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years | Assessed by measured weight |
| Mean Body Composition-body Mass Index (BMI) | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years | Assessed from measured weight and measured height |
| Mean Body Composition-body Fat | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years | Assessed by dual energy X-ray absorptiometry (DEXA) |
| Body Composition-lean Body Mass | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years | Assessed by dual energy X-ray absorptiometry (DEXA) |
| Body Composition-bone Mineral Density | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years | Assessed by dual energy X-ray absorptiometry (DEXA), -1.0 or higher are normal; -1.1 to -2.4 indicate low bone mass (osteopenia), and -2.5 or lower indicate osteoporosis. |
| Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH) | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years | PROMIS Global Physical Health (GPH) score is a measure of physical well-being. It uses a T-score metric standardized to a U.S. general population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health, with scores typically ranging from 20 to 80. |
| Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH) | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years | PROMIS Global Mental Health (GMH) score is a measure of mental well-being. It uses a T-score metric standardized to a U.S. general population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health, with scores typically ranging from 20 to 80. |
| Fecal Microbiome | Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year | Number of participants that were able to provide a sample. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMelinda Irwin, Ph.D.
Yale University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dietary/Physical Activity Intervention Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program).
Dietary/Physical Activity intervention: Motivational counseling to follow established dietary and exercise guidelines. | 87 |
| Usual Care Group Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant).
Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study.
Usual Care: Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial. | 86 |
| Total | 173 |
Baseline characteristics
| Characteristic | Dietary/Physical Activity Intervention | Usual Care Group | Total |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 11.3 | 53.3 years STANDARD_DEVIATION 10.9 | 52.8 years STANDARD_DEVIATION 11.1 |
| Body Mass Index (BMI) | 29.5 kg/m^2 STANDARD_DEVIATION 7 | 29.8 kg/m^2 STANDARD_DEVIATION 6.6 | 29.7 kg/m^2 STANDARD_DEVIATION 6.8 |
| Cancer Stage Stage I | 45 Participants | 43 Participants | 88 Participants |
| Cancer Stage Stage II | 31 Participants | 34 Participants | 65 Participants |
| Cancer Stage Stage III | 11 Participants | 9 Participants | 20 Participants |
| Chemotherapy Adjuvant | 46 Participants | 54 Participants | 100 Participants |
| Chemotherapy Neoadjuvant | 41 Participants | 32 Participants | 73 Participants |
| Chemotherapy Cycles >4 (range of weeks: 12-24) | 64 Participants | 61 Participants | 125 Participants |
| Chemotherapy Cycles 4 (range of weeks: 8-12) | 23 Participants | 25 Participants | 48 Participants |
| Postmenopausal Status Postmenopausal: No | 39 Participants | 40 Participants | 79 Participants |
| Postmenopausal Status Postmenopausal: Yes | 48 Participants | 46 Participants | 94 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Asian or Pacific Islander | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Hispanic | 8 Participants | 5 Participants | 13 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-Hispanic Black | 11 Participants | 14 Participants | 25 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-Hispanic White | 61 Participants | 62 Participants | 123 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Prefer not to answer | 3 Participants | 0 Participants | 3 Participants |
| Receptor Status ER/PR+, HER2- | 49 Participants | 50 Participants | 99 Participants |
| Receptor Status ER/PR+/-, HER2+ | 15 Participants | 15 Participants | 30 Participants |
| Receptor Status Triple negative | 23 Participants | 21 Participants | 44 Participants |
| Region of Enrollment United States | 87 participants | 86 participants | 173 participants |
| Sex: Female, Male Female | 87 Participants | 86 Participants | 173 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Study Site Dana-Farber Cancer Institute | 24 Participants | 27 Participants | 51 Participants |
| Study Site Yale | 63 Participants | 59 Participants | 122 Participants |
| Time since diagnosis | 60 days STANDARD_DEVIATION 34 | 68 days STANDARD_DEVIATION 32 | 63 days STANDARD_DEVIATION 33 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 5 / 86 |
| other Total, other adverse events | 78 / 87 | 70 / 86 |
| serious Total, serious adverse events | 45 / 87 | 47 / 86 |
Outcome results
Primary
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. 1. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted) 2. In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) 3. In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)
Time frame: 12 months after enrollment
Population: Participants eligible for Endocrine Therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dietary/Physical Activity Intervention | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) | Q2. Never | 23 Participants |
| Dietary/Physical Activity Intervention | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) | Q3. Never | 35 Participants |
| Dietary/Physical Activity Intervention | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) | Q1. All the Time | 29 Participants |
| Usual Care Group | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) | Q1. All the Time | 23 Participants |
| Usual Care Group | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) | Q3. Never | 29 Participants |
| Usual Care Group | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs) | Q2. Never | 18 Participants |
Comparison: Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'p-value: 0.33Chi-squared
Comparison: Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'p-value: 0.44Chi-squared
Comparison: Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'p-value: 0.29Chi-squared
Primary
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).
This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted- Q1) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q2) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q3)
Time frame: 24 months after enrollment
Population: Participants eligible for Endocrine Therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dietary/Physical Activity Intervention | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). | Q1. = All the Time | 22 Participants |
| Dietary/Physical Activity Intervention | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). | Q3. = Never | 33 Participants |
| Dietary/Physical Activity Intervention | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). | Q2. = Never | 20 Participants |
| Usual Care Group | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). | Q3. = Never | 25 Participants |
| Usual Care Group | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). | Q1. = All the Time | 22 Participants |
| Usual Care Group | Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs). | Q2. = Never | 18 Participants |
Comparison: Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'p-value: 0.69Chi-squared
Comparison: Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'p-value: 0.91Chi-squared
Comparison: Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'p-value: 0.13Chi-squared
Primary
Adherence to Treatment Measured by Chemotherapy Completion Rate
Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose.
Time frame: before initiating chemotherapy to post-chemotherapy, up to 7 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary/Physical Activity Intervention | Adherence to Treatment Measured by Chemotherapy Completion Rate | 93.9 percentage of actual dose/planned dose | Standard Deviation 12.1 |
| Usual Care Group | Adherence to Treatment Measured by Chemotherapy Completion Rate | 93.6 percentage of actual dose/planned dose | Standard Deviation 11.1 |
p-value: 0.69t-test, 2 sided
Secondary
Body Composition-BMI
Assessed from measured weight and measured height
Time frame: one year post-diagnosis
Secondary
Body Composition-BMI
Assessed from measured weight and measured height
Time frame: two years post-diagnosis
Secondary
Body Composition-body Fat
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: Up to 7 months from treatment onset
Secondary
Body Composition-body Fat
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: Baseline (pre-chemotherapy)
Secondary
Body Composition-body Fat
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: one year post-diagnosis
Secondary
Body Composition-body Fat
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: two years post-diagnosis
Secondary
Body Composition-body Mass Index (BMI)
Assessed from measured weight and measured height
Time frame: Up to 7 months from treatment onset
Secondary
Body Composition-body Mass Index (BMI)
Assessed from measured weight and measured height
Time frame: Baseline (pre-chemotherapy)
Secondary
Body Composition-body Weight
Assessed by measured weight
Time frame: Up to 7 months from treatment onset
Secondary
Body Composition-body Weight
Assessed by measured weight
Time frame: two years post-diagnosis
Secondary
Body Composition-body Weight
Assessed by measured weight
Time frame: one year post-diagnosis
Secondary
Body Composition-body Weight
Assessed by measured weight
Time frame: Baseline (pre-chemotherapy)
Secondary
Body Composition-bone Mineral Density
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: Baseline (pre-chemotherapy)
Secondary
Body Composition-bone Mineral Density
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: Up to 7 months from treatment onset
Secondary
Body Composition-bone Mineral Density
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: two years post-diagnosis
Secondary
Body Composition-bone Mineral Density.
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: one year post-diagnosis
Secondary
Body Composition-lean Body Mass
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: one year post-diagnosis
Secondary
Body Composition-lean Body Mass
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: Up to 7 months from treatment onset
Secondary
Body Composition-lean Body Mass
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: Baseline (pre-chemotherapy)
Secondary
Body Composition-lean Bone Mass
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: two years post-diagnosis
Secondary
C-reactive Protein Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: two years post-diagnosis
Secondary
C-reactive Protein Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: Baseline (pre-chemotherapy)
Secondary
C-reactive Protein Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: one year post-diagnosis
Secondary
C-reactive Protein Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: Up to 7 months from treatment onset
Secondary
Fecal Microbiome
Assessed by stool collection.
Time frame: Up to 7 months from treatment onset
Secondary
Fecal Microbiome
Assessed by stool collection.
Time frame: Baseline (pre-chemotherapy)
Secondary
Fecal Microbiome
Assessed by stool collection.
Time frame: two years post-diagnosis
Secondary
Fecal Microbiome
Assessed by stool collection.
Time frame: one year post-diagnosis
Secondary
Healthy Eating Index
Assessed by food frequency questionnaire
Time frame: five years post-diagnosis
Secondary
Insulin Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: Baseline (pre-chemotherapy)
Secondary
Insulin Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: two years post-diagnosis
Secondary
Insulin Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: Up to 7 months from treatment onset
Secondary
Insulin Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: one year post-diagnosis
Secondary
Minutes Per Week of Moderate/Vigorous Physical Activity
Assessed by the modified physical activity questionnaire
Time frame: five years post-diagnosis
Secondary
Pathological Complete Response
In the subset of patients receiving neoadjuvant chemotherapy, no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen.
Time frame: At the time of surgical resection following initial course of chemotherapy
Secondary
Quality of Life
Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
Time frame: Up to 7 months from treatment onset
Secondary
Quality of Life
Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
Time frame: Baseline (pre-chemotherapy)
Secondary
Quality of Life
Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
Time frame: one year post-diagnosis
Secondary
Quality of Life
Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
Time frame: two years post-diagnosis