Trial Outcomes & Findings for Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (NCT NCT03314688)
NCT ID: NCT03314688
Last Updated: 2026-07-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
173 participants
Primary outcome timeframe
before initiating chemotherapy to post-chemotherapy, up to 7 months
Results posted on
2026-07-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
86
|
|
Overall Study
Eligible for Endocrine Therapy
|
40
|
37
|
|
Overall Study
COMPLETED
|
87
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis
Baseline characteristics by cohort
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 11.3 • n=20 Participants
|
53.3 years
STANDARD_DEVIATION 10.9 • n=20 Participants
|
52.8 years
STANDARD_DEVIATION 11.1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=20 Participants
|
86 Participants
n=20 Participants
|
173 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Non-Hispanic White
|
61 Participants
n=20 Participants
|
62 Participants
n=20 Participants
|
123 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Non-Hispanic Black
|
11 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Hispanic
|
8 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Asian or Pacific Islander
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Prefer not to answer
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race and Ethnicity · Other
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=20 Participants
|
86 participants
n=20 Participants
|
173 participants
n=40 Participants
|
|
Study Site
Yale
|
63 Participants
n=20 Participants
|
59 Participants
n=20 Participants
|
122 Participants
n=40 Participants
|
|
Study Site
Dana-Farber Cancer Institute
|
24 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
51 Participants
n=40 Participants
|
|
Body Mass Index (BMI)
|
29.5 kg/m^2
STANDARD_DEVIATION 7.0 • n=20 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 6.6 • n=20 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 6.8 • n=40 Participants
|
|
Postmenopausal Status
Postmenopausal: Yes
|
48 Participants
n=20 Participants
|
46 Participants
n=20 Participants
|
94 Participants
n=40 Participants
|
|
Postmenopausal Status
Postmenopausal: No
|
39 Participants
n=20 Participants
|
40 Participants
n=20 Participants
|
79 Participants
n=40 Participants
|
|
Cancer Stage
Stage I
|
45 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
88 Participants
n=40 Participants
|
|
Cancer Stage
Stage II
|
31 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
65 Participants
n=40 Participants
|
|
Cancer Stage
Stage III
|
11 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Receptor Status
ER/PR+, HER2-
|
49 Participants
n=20 Participants
|
50 Participants
n=20 Participants
|
99 Participants
n=40 Participants
|
|
Receptor Status
ER/PR+/-, HER2+
|
15 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Receptor Status
Triple negative
|
23 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
|
Chemotherapy
Neoadjuvant
|
41 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
73 Participants
n=40 Participants
|
|
Chemotherapy
Adjuvant
|
46 Participants
n=20 Participants
|
54 Participants
n=20 Participants
|
100 Participants
n=40 Participants
|
|
Chemotherapy Cycles
4 (range of weeks: 8-12)
|
23 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
48 Participants
n=40 Participants
|
|
Chemotherapy Cycles
>4 (range of weeks: 12-24)
|
64 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
125 Participants
n=40 Participants
|
|
Time since diagnosis
|
60 days
STANDARD_DEVIATION 34 • n=20 Participants
|
68 days
STANDARD_DEVIATION 32 • n=20 Participants
|
63 days
STANDARD_DEVIATION 33 • n=40 Participants
|
PRIMARY outcome
Timeframe: before initiating chemotherapy to post-chemotherapy, up to 7 monthsChemotherapy 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.
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Adherence to Treatment Measured by Chemotherapy Completion Rate
|
93.9 percentage of actual dose/planned dose
Standard Deviation 12.1
|
93.6 percentage of actual dose/planned dose
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: 12 months after enrollmentPopulation: Participants eligible for Endocrine Therapy.
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)
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=40 Participants
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.
|
Usual Care Group
n=37 Participants
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.
|
|---|---|---|
|
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
Q3. Never
|
35 Participants
|
29 Participants
|
|
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
Q1. All the Time
|
29 Participants
|
23 Participants
|
|
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
Q2. Never
|
23 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 24 months after enrollmentPopulation: Participants eligible for Endocrine Therapy.
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)
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=40 Participants
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.
|
Usual Care Group
n=37 Participants
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.
|
|---|---|---|
|
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).
Q1. = All the Time
|
22 Participants
|
22 Participants
|
|
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).
Q2. = Never
|
20 Participants
|
18 Participants
|
|
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).
Q3. = Never
|
33 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: At the time of surgical resection following initial course of chemotherapyIn 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.
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=40 Participants
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.
|
Usual Care Group
n=32 Participants
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.
|
|---|---|---|
|
Pathological Complete Response
|
21 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 yearAssessed by fasting blood (fast of 12 hours or more).
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Mean Insulin Level
Baseline (pre-chemotherapy)
|
19.7 uIU/ml
Standard Deviation 29.9
|
18.0 uIU/ml
Standard Deviation 12.8
|
|
Mean Insulin Level
Post Chemo
|
12.6 uIU/ml
Standard Deviation 10.4
|
29.4 uIU/ml
Standard Deviation 35.6
|
|
Mean Insulin Level
1 year
|
12.8 uIU/ml
Standard Deviation 5.9
|
24.6 uIU/ml
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 yearAssessed by fasting blood (fast of 12 hours or more).
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Mean C-reactive Protein Level
Baseline
|
4.9 ug/ml
Standard Deviation 3.3
|
4.2 ug/ml
Standard Deviation 3.0
|
|
Mean C-reactive Protein Level
Post Chemo
|
5.0 ug/ml
Standard Deviation 3.2
|
4.6 ug/ml
Standard Deviation 3.5
|
|
Mean C-reactive Protein Level
1 year
|
2.9 ug/ml
Standard Deviation 2.3
|
3.6 ug/ml
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 yearsAssessed by measured weight
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Mean Body Composition-body Weight
Baseline
|
76.4 kg
Standard Deviation 17.3
|
79.0 kg
Standard Deviation 18.5
|
|
Mean Body Composition-body Weight
Post Chemo
|
73.2 kg
Standard Deviation 14.1
|
76.1 kg
Standard Deviation 18.7
|
|
Mean Body Composition-body Weight
1 year
|
75.1 kg
Standard Deviation 17.6
|
73.5 kg
Standard Deviation 18.3
|
|
Mean Body Composition-body Weight
2 years
|
79.9 kg
Standard Deviation 18.2
|
73.9 kg
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 yearsAssessed from measured weight and measured height
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Mean Body Composition-body Mass Index (BMI)
1 year
|
28.1 kg/m^2
Standard Deviation 6.4
|
28.8 kg/m^2
Standard Deviation 7.5
|
|
Mean Body Composition-body Mass Index (BMI)
2 years
|
29.8 kg/m^2
Standard Deviation 6.8
|
29.7 kg/m^2
Standard Deviation 7.0
|
|
Mean Body Composition-body Mass Index (BMI)
Baseline
|
28.4 kg/m^2
Standard Deviation 6.4
|
30.2 kg/m^2
Standard Deviation 6.9
|
|
Mean Body Composition-body Mass Index (BMI)
Post Chemo
|
27.3 kg/m^2
Standard Deviation 5.6
|
29.0 kg/m^2
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 yearsAssessed by dual energy X-ray absorptiometry (DEXA)
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Mean Body Composition-body Fat
2 years
|
35.1 kg
Standard Deviation 13.1
|
32.0 kg
Standard Deviation 10.0
|
|
Mean Body Composition-body Fat
Baseline
|
31.4 kg
Standard Deviation 11.1
|
33.9 kg
Standard Deviation 11.2
|
|
Mean Body Composition-body Fat
Post Chemo
|
29.0 kg
Standard Deviation 9.9
|
31.9 kg
Standard Deviation 11.7
|
|
Mean Body Composition-body Fat
1 year
|
31.9 kg
Standard Deviation 12.4
|
31.5 kg
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 yearsAssessed by dual energy X-ray absorptiometry (DEXA)
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Body Composition-lean Body Mass
Baseline
|
42.3 kg
Standard Deviation 7.0
|
41.7 kg
Standard Deviation 7.9
|
|
Body Composition-lean Body Mass
Post Chemo
|
41.0 kg
Standard Deviation 5.8
|
41.1 kg
Standard Deviation 8.3
|
|
Body Composition-lean Body Mass
1 year
|
41.5 kg
Standard Deviation 6.3
|
39.9 kg
Standard Deviation 6.6
|
|
Body Composition-lean Body Mass
2 years
|
43.5 kg
Standard Deviation 6.5
|
40.9 kg
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 yearsAssessed 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.
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Body Composition-bone Mineral Density
Baseline
|
1.1 T-score
Standard Deviation 0.1
|
1.1 T-score
Standard Deviation 0.1
|
|
Body Composition-bone Mineral Density
Post Chemo
|
1.1 T-score
Standard Deviation 0.1
|
1.1 T-score
Standard Deviation 0.1
|
|
Body Composition-bone Mineral Density
1 year
|
1.1 T-score
Standard Deviation 0.1
|
1.1 T-score
Standard Deviation 0.1
|
|
Body Composition-bone Mineral Density
2 years
|
1.1 T-score
Standard Deviation 0.1
|
1.1 T-score
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 yearsPROMIS 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.
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)
Baseline
|
49.6 T score
Standard Deviation 7.3
|
48.7 T score
Standard Deviation 6.9
|
|
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)
Post Chemo
|
38.0 T score
Standard Deviation 4.7
|
39.2 T score
Standard Deviation 4.0
|
|
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)
1 year
|
49.2 T score
Standard Deviation 7.6
|
47.9 T score
Standard Deviation 7.5
|
|
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)
2 years
|
48.8 T score
Standard Deviation 7.9
|
48.5 T score
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 yearsPROMIS 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.
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)
Post Chemo
|
39.6 T score
Standard Deviation 6.7
|
40.5 T score
Standard Deviation 7.0
|
|
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)
1 year
|
49.2 T score
Standard Deviation 9.0
|
48.2 T score
Standard Deviation 10.0
|
|
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)
Baseline
|
49.9 T score
Standard Deviation 8.1
|
51.6 T score
Standard Deviation 8.6
|
|
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)
2 years
|
49.4 T score
Standard Deviation 9.7
|
50.3 T score
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 yearNumber of participants that were able to provide a sample.
Outcome measures
| Measure |
Dietary/Physical Activity Intervention
n=87 Participants
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.
|
Usual Care Group
n=86 Participants
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.
|
|---|---|---|
|
Fecal Microbiome
Baseline
|
4 Participants
|
9 Participants
|
|
Fecal Microbiome
Post Chemo
|
10 Participants
|
11 Participants
|
|
Fecal Microbiome
1 Year
|
10 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: five years post-diagnosisAssessed by the modified physical activity questionnaire
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: five years post-diagnosisAssessed by food frequency questionnaire
Outcome measures
Outcome data not reported
Adverse Events
Dietary/Physical Activity Intervention
Serious events: 45 serious events
Other events: 78 other events
Deaths: 0 deaths
Usual Care Group
Serious events: 47 serious events
Other events: 70 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Dietary/Physical Activity Intervention
n=87 participants at risk
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.
|
Usual Care Group
n=86 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Severity of dry mouth
|
17.1%
14/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
18.9%
14/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of difficulty swallowing
|
2.4%
2/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
8.1%
6/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Infections and infestations
Severity of mouth or throat sores
|
4.9%
4/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
6.8%
5/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Infections and infestations
Inference of mouth or throat sores
|
1.2%
1/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
6.8%
5/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Nervous system disorders
Severity of problems with tasting
|
20.7%
17/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
21.6%
16/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Metabolism and nutrition disorders
Severity of decreased appetite
|
17.1%
14/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
9.5%
7/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Metabolism and nutrition disorders
Inference of decreased appetite
|
8.5%
7/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
9.5%
7/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Frequency of nausea
|
12.2%
10/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
9.5%
7/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of nausea
|
9.8%
8/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
6.8%
5/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of vomiting
|
1.2%
1/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
2.7%
2/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Frequency of heartburn
|
15.9%
13/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
17.6%
13/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of heartburn
|
9.8%
8/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
9.5%
7/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of constipation
|
14.6%
12/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
12.2%
9/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Frequency of diarrhea
|
15.9%
13/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
16.2%
12/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
Other adverse events
| Measure |
Dietary/Physical Activity Intervention
n=87 participants at risk
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.
|
Usual Care Group
n=86 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Severity of dry mouth
|
56.1%
46/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
59.5%
44/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of difficulty swallowing
|
28.0%
23/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
27.0%
20/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Infections and infestations
Severity of mouth or throat sores
|
37.8%
31/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
40.5%
30/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Infections and infestations
Inference of mouth or throat sores
|
18.3%
15/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
25.7%
19/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Nervous system disorders
Severity of problems with tasting
|
70.7%
58/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
70.3%
52/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Metabolism and nutrition disorders
Severity of decreased appetite
|
47.6%
39/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
52.7%
39/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Metabolism and nutrition disorders
Inference of decreased appetite
|
29.3%
24/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
36.5%
27/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Frequency of nausea
|
50.0%
41/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
37.8%
28/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of nausea
|
48.8%
40/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
28.4%
21/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Frequency of vomiting
|
12.2%
10/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
6.8%
5/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of vomiting
|
9.8%
8/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
8.1%
6/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Frequency of heartburn
|
50.0%
41/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
50.0%
37/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of heartburn
|
41.5%
34/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
41.9%
31/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Severity of constipation
|
39.0%
32/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
33.8%
25/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
|
Gastrointestinal disorders
Frequency of diarrhea
|
50.0%
41/82 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
44.6%
33/74 • Up to 24 months
PRO-CTCAE was used to assess participant Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place