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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA207753-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | Active Comparator | 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. |
|
| Dietary/Physical Activity Intervention | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary/Physical Activity intervention | Behavioral | Motivational counseling to follow established dietary and exercise guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before initiating chemotherapy to post-chemotherapy, up to 7 months |
| 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.
| 12 months after enrollment |
| 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) | 24 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of surgical resection following initial course of chemotherapy |
| Insulin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Irwin, Ph.D. | Yale University | Principal Investigator |
| Tara Sanft, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States | ||
| Dana Farber Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41452765 | Derived | Puklin LS, Li FY, Ferrucci LM, Cartmel B, Harrigan M, McGowan C, Zupa M, Ligibel JA, Sanft T, Irwin ML. Effect of a lifestyle intervention during chemotherapy for breast cancer on quality of life. JNCI Cancer Spectr. 2026 Jan 9;10(1):pkaf125. doi: 10.1093/jncics/pkaf125. | |
| 37656930 | Derived | Sanft T, Harrigan M, McGowan C, Cartmel B, Zupa M, Li FY, Ferrucci LM, Puklin L, Cao A, Nguyen TH, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones BA, Knobf T, Chagpar AB, Silber A, Tanasijevic A, Ligibel JA, Irwin ML. Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study. J Clin Oncol. 2023 Dec 1;41(34):5285-5295. doi: 10.1200/JCO.23.00871. Epub 2023 Sep 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of actual dose/planned dose | before initiating chemotherapy to post-chemotherapy, up to 7 months |
|
Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severity of dry mouth | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severity of dry mouth | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara Sanft, MD | Yale School of Medicine | (203) 200-2328 | tara.sanft@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2024 | Mar 20, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 4, 2021 | Feb 1, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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.
| Usual Care | Behavioral | Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial. |
|
Assessed by fasting blood (fast of 12 hours or more). |
| Baseline (pre-chemotherapy) |
| Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | Up to 7 months from treatment onset |
| Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | one year post-diagnosis |
| Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | two years post-diagnosis |
| C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | Baseline (pre-chemotherapy) |
| C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | Up to 7 months from treatment onset |
| C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | one year post-diagnosis |
| C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | two years post-diagnosis |
| Body Composition-body Weight | Assessed by measured weight | Baseline (pre-chemotherapy) |
| Body Composition-body Mass Index (BMI) | Assessed from measured weight and measured height | Baseline (pre-chemotherapy) |
| Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) |
| Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) |
| Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) |
| Body Composition-body Weight | Assessed by measured weight | Up to 7 months from treatment onset |
| Body Composition-body Mass Index (BMI) | Assessed from measured weight and measured height | Up to 7 months from treatment onset |
| Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset |
| Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset |
| Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset |
| Body Composition-body Weight | Assessed by measured weight | one year post-diagnosis |
| Body Composition-BMI | Assessed from measured weight and measured height | one year post-diagnosis |
| Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis |
| Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis |
| Body Composition-bone Mineral Density. | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis |
| Body Composition-body Weight | Assessed by measured weight | two years post-diagnosis |
| Body Composition-BMI | Assessed from measured weight and measured height | two years post-diagnosis |
| Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis |
| Body Composition-lean Bone Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis |
| Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis |
| Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Baseline (pre-chemotherapy) |
| Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Up to 7 months from treatment onset |
| Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | one year post-diagnosis |
| Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | two years post-diagnosis |
| Fecal Microbiome | Assessed by stool collection. | Baseline (pre-chemotherapy) |
| Fecal Microbiome | Assessed by stool collection. | Up to 7 months from treatment onset |
| Fecal Microbiome | Assessed by stool collection. | one year post-diagnosis |
| Fecal Microbiome | Assessed by stool collection. | two years post-diagnosis |
| Healthy Eating Index | Assessed by food frequency questionnaire | five years post-diagnosis |
| Minutes Per Week of Moderate/Vigorous Physical Activity | Assessed by the modified physical activity questionnaire | five years post-diagnosis |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| 34274495 | Derived | Sanft T, Harrigan M, Cartmel B, Ferrucci LM, Li FY, McGowan C, Zupa M, Nguyen TH, Ligibel J, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones B, Knobf T, Chagpar A, Silber A, Irwin ML. Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial. Contemp Clin Trials. 2021 Oct;109:106508. doi: 10.1016/j.cct.2021.106508. Epub 2021 Jul 16. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Study Site | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Postmenopausal Status | Count of Participants | Participants |
|
| Cancer Stage | This measure is from the five stages of breast cancer, starting at zero and going up to four. Stages are represented by the Roman numerals I, II, III, and IV. Stage IV is the most advanced stage of breast cancer. | Count of Participants | Participants |
|
| Receptor Status | Count of Participants | Participants |
|
| Chemotherapy | Count of Participants | Participants |
|
| Chemotherapy Cycles | Count of Participants | Participants |
|
| Time since diagnosis | Mean | Standard Deviation | days |
|
| OG001 | 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. |
|
|
|
| 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.
| Participants eligible for Endocrine Therapy. | Posted | Count of Participants | Participants | 12 months after enrollment |
|
|
|
|
| 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) | Participants eligible for Endocrine Therapy. | Posted | Count of Participants | Participants | 24 months after enrollment |
|
|
|
|
| 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. | Not Posted | At the time of surgical resection following initial course of chemotherapy | Participants |
| Secondary | Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | Not Posted | one year post-diagnosis | Participants |
| Secondary | Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | Not Posted | two years post-diagnosis | Participants |
| Secondary | C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | Not Posted | one year post-diagnosis | Participants |
| Secondary | C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | Not Posted | two years post-diagnosis | Participants |
| Secondary | Body Composition-body Weight | Assessed by measured weight | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | Body Composition-body Mass Index (BMI) | Assessed from measured weight and measured height | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | Body Composition-body Weight | Assessed by measured weight | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | Body Composition-body Mass Index (BMI) | Assessed from measured weight and measured height | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | Body Composition-body Weight | Assessed by measured weight | Not Posted | one year post-diagnosis | Participants |
| Secondary | Body Composition-BMI | Assessed from measured weight and measured height | Not Posted | one year post-diagnosis | Participants |
| Secondary | Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | one year post-diagnosis | Participants |
| Secondary | Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | one year post-diagnosis | Participants |
| Secondary | Body Composition-bone Mineral Density. | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | one year post-diagnosis | Participants |
| Secondary | Body Composition-body Weight | Assessed by measured weight | Not Posted | two years post-diagnosis | Participants |
| Secondary | Body Composition-BMI | Assessed from measured weight and measured height | Not Posted | two years post-diagnosis | Participants |
| Secondary | Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | two years post-diagnosis | Participants |
| Secondary | Body Composition-lean Bone Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | two years post-diagnosis | Participants |
| Secondary | Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | Not Posted | two years post-diagnosis | Participants |
| Secondary | Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Not Posted | one year post-diagnosis | Participants |
| Secondary | Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Not Posted | two years post-diagnosis | Participants |
| Secondary | Fecal Microbiome | Assessed by stool collection. | Not Posted | Baseline (pre-chemotherapy) | Participants |
| Secondary | Fecal Microbiome | Assessed by stool collection. | Not Posted | Up to 7 months from treatment onset | Participants |
| Secondary | Fecal Microbiome | Assessed by stool collection. | Not Posted | one year post-diagnosis | Participants |
| Secondary | Fecal Microbiome | Assessed by stool collection. | Not Posted | two years post-diagnosis | Participants |
| Secondary | Healthy Eating Index | Assessed by food frequency questionnaire | Not Posted | five years post-diagnosis | Participants |
| Secondary | Minutes Per Week of Moderate/Vigorous Physical Activity | Assessed by the modified physical activity questionnaire | Not Posted | five years post-diagnosis | Participants |
| 0 |
| 87 |
| 45 |
| 87 |
| 78 |
| 87 |
| EG001 | 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 2-year 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. | 5 | 86 | 47 | 86 | 70 | 86 |
| Severity of difficulty swallowing | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of mouth or throat sores | Infections and infestations | PRO-CTCAE | Systematic Assessment |
|
| Inference of mouth or throat sores | Infections and infestations | PRO-CTCAE | Systematic Assessment |
|
| Severity of problems with tasting | Nervous system disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of decreased appetite | Metabolism and nutrition disorders | PRO-CTCAE | Systematic Assessment |
|
| Inference of decreased appetite | Metabolism and nutrition disorders | PRO-CTCAE | Systematic Assessment |
|
| Frequency of nausea | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of nausea | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of vomiting | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Frequency of heartburn | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of heartburn | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of constipation | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Frequency of diarrhea | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of difficulty swallowing | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of mouth or throat sores | Infections and infestations | PRO-CTCAE | Systematic Assessment |
|
| Inference of mouth or throat sores | Infections and infestations | PRO-CTCAE | Systematic Assessment |
|
| Severity of problems with tasting | Nervous system disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of decreased appetite | Metabolism and nutrition disorders | PRO-CTCAE | Systematic Assessment |
|
| Inference of decreased appetite | Metabolism and nutrition disorders | PRO-CTCAE | Systematic Assessment |
|
| Frequency of nausea | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of nausea | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Frequency of vomiting | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of vomiting | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Frequency of heartburn | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of heartburn | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Severity of constipation | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
| Frequency of diarrhea | Gastrointestinal disorders | PRO-CTCAE | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Q3. Never |
|
| Chi-squared |
| 0.44 |
| Superiority |
| 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' | Chi-squared | 0.29 | Superiority |
| Q3. = Never |
|
| Chi-squared |
| 0.91 |
| Superiority |
| 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' | Chi-squared | 0.13 | Superiority |