Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants and Recruitment
2.2. Usual Care
2.3. Weight Loss Intervention
2.4. Data Collection
2.4.1. Primary Outcome
2.4.2. Secondary Outcomes
2.4.3. Adverse Events
2.5. Sample Size
2.6. Data Analysis
3. Results
3.1. Weight and Body Composition
3.2. Metabolic Syndrome
3.3. Patient-Reported Outcomes
3.4. Adverse Events
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | Usual Care (n = 80) | Intervention (n = 79) |
---|---|---|
Mean (SD) | ||
Age (years) | 54.9 (9.3) | 55.9 (9.1) |
BMI (kg/m2) | 31.3 (5.2) | 31.4 (4.9) |
Months since diagnosis | 10.8 (5.3) | 10.7 (4.8) |
Months since treatment completion | 4.9 (4.6) | 5.2 (4.7) |
n (%) | ||
Menopausal status at diagnosis | ||
Premenopausal | 31 (39%) | 28 (35%) |
Perimenopausal a | 15 (19%) | 6 (8%) |
Postmenopausal a | 34 (42%) | 45 (57%) |
Breast cancer stage b | ||
Stage 1 | 46 (58%) | 40 (51%) |
Stage 2 | 24 (30%) | 30 (38%) |
Stage 3 | 9 (11%) | 9 (11%) |
Estrogen receptor status b | ||
Positive | 72 (91%) | 67 (85%) |
Negative | 7 (9%) | 12 (15%) |
HER2 b | ||
Positive | 9 (11%) | 11 (14%) |
Negative | 68 (86%) | 68 (86%) |
Equivocal | 2 (3%) | 0 (0%) |
Chemotherapy treatment | 51 (64%) | 48 (61%) |
Radiotherapy treatment | 63 (79%) | 63 (80%) |
Endocrine treatment | ||
None | 35 (44%) | 32 (41%) |
SERM | 19 (24%) | 22 (28%) |
Aromatase inhibitor | 26 (32%) | 24 (30%) |
GnRH agonist | 0 (0%) | 1 (1%) |
Metabolic syndrome present | 37 (48%) | 37 (47%) |
Charlson Comorbidity Index c | ||
0 | 51 (64%) | 47 (60%) |
1 | 18 (22%) | 13 (16%) |
≥2 a | 11 (14%) | 19 (24%) |
Married or stable union | 56 (70.0%) | 54 (68.4%) |
Caucasian | 78 (97.5%) | 78 (98.7%) |
Employment status | ||
Paid work | 44 (55%) | 50 (63%) |
Retired, home duties, unable to work, other | 36 (45%) | 29 (37%) |
n (%) | ||
Highest education level | ||
High school or less | 32 (40%) | 32 (41%) |
Technical/trade/diploma | 21 (26%) | 16 (20%) |
University or higher | 27 (34%) | 31 (39%) |
Gross household income (AUD) d | ||
<$82,056 per year | 34 (42%) | 37 (47%) |
≥$82,056 per year | 38 (48%) | 33 (42%) |
Not reported/not known | 8 (10%) | 9 (11%) |
Outcome | Timepoint | Intervention | Usual Care | Intervention Effect (Intervention—Usual Care) | ||||
---|---|---|---|---|---|---|---|---|
n | Mean Change (95% CI) | n | Mean Change (95% CI) | Mean Difference (95% CI) | p | d a | ||
Weight (% of baseline value) | Baseline M (SD) | 79 | 83.9 (14.2) | 80 | 83.6 (13.6) | |||
6 months | 73 | −4.61 (−5.77, −3.44) | 70 | −0.52 (−1.70, 0.67) | −4.09 (−5.75, −2.43) | <0.001 | −0.30 | |
12 months b | 70 | −5.06 (−6.46, −3.66) | 60 | −0.58 (−2.02, 0.85) | −4.48 (−6.48, −2.47) | <0.001 | −0.32 | |
18 months | 68 | −3.69 (−5.23, −2.16) | 60 | −0.62 (−2.22, 0.97) | −3.07 (−5.28, −0.86) | 0.007 | −0.22 | |
Weight (kg) | Baseline M (SD) | 79 | 83.9 (14.2) | 80 | 83.6 (13.6) | |||
6 months | 73 | −3.74 (−4.71, −2.76) | 70 | −0.43 (−1.42, 0.56) | −3.31 (−4.70, −1.92) | <0.001 | −0.24 | |
12 months b | 70 | −4.12 (−5.28, −2.96) | 60 | −0.52 (−1.71, 0.67) | −3.60 (−5.26, −1.94) | <0.001 | −0.26 | |
18 months | 68 | −3.03 (−4.34, −1.73) | 60 | −0.56 (−1.91, 0.80) | −2.48 (−4.36, −0.59) | 0.010 | −0.18 | |
Total fat mass (kg) | Baseline M (SD) | 73 | 38.8 (10.4) | 70 | 37.5 (10.2) | |||
6 months | 67 | −3.13 (−3.97, −2.30) | 62 | 0.13 (−0.73, 1.00) | −3.26 (−4.47, −2.06) | <0.001 | −0.32 | |
12 months b | 64 | −3.27 (−4.26, −2.29) | 54 | 0.05 (−0.98, 1.08) | −3.32 (−4.75, −1.90) | <0.001 | −0.32 | |
18 months | 63 | −2.11 (−3.19, −1.03) | 54 | −0.29 (−1.43, 0.85) | −1.82 (−3.39, −0.25) | 0.023 | −0.18 | |
Total lean mass (kg) | Baseline M (SD) | 73 | 42.8 (5.0) | 70 | 43.6 (5.2) | |||
6 months | 67 | −0.96 (−1.28, −0.63) | 62 | −0.24 (−0.57, 0.09) | −0.71 (−1.18, −0.25) | 0.002 | −0.14 | |
12 months b | 64 | −1.07 (−1.46, −0.68) | 54 | −0.52 (−0.93, −0.10) | −0.55 (−1.12, 0.02) | 0.059 | −0.11 | |
18 months | 63 | −1.20 (−1.63, −0.77) | 54 | −0.14 (−0.59, 0.32) | −1.06 (−1.68, −0.43) | <0.001 | −0.21 | |
Metabolic syndrome risk score | Baseline M (SD) | 78 | 0.65 (0.60) | 77 | 0.63 (0.59) | |||
6 months | 69 | −0.19 (−0.27, −0.11) | 65 | 0.03 (−0.05, 0.12) | −0.22 (−0.34, −0.10) | <0.001 | −0.37 | |
12 months b | 67 | −0.18 (−0.27, −0.08) | 56 | 0.01 (−0.09, 0.11) | −0.19 (−0.32, −0.05) | 0.006 | −0.32 | |
18 months | 66 | −0.15 (−0.24, −0.06) | 57 | 0.01 (−0.08, 0.11) | −0.16 (−0.29, −0.03) | 0.014 | −0.27 | |
Waist circumference (cm) | Baseline M (SD) | 79 | 106.7 (11.7) | 80 | 104.9 (10.4) | |||
6 months | 73 | −3.47 (−4.95, −1.99) | 70 | −0.64 (−2.14, 0.87) | −2.83 (−4.94, −0.71) | 0.009 | −0.26 | |
12 months b | 70 | −5.50 (−7.11, −3.89) | 60 | −2.30 (−3.98, −0.62) | −3.20 (−5.53, −0.87) | 0.007 | −0.29 | |
18 months | 68 | −5.29 (−6.81, −3.78) | 60 | −2.50 (−4.08, −0.91) | −2.80 (−4.99, −0.61) | 0.012 | −0.25 | |
Triglycerides (mmol/L) c | Baseline M (SD) | 78 | 1.4 (0.7) | 78 | 1.5 (0.9) | |||
6 months | 71 | −0.03 (−0.12, 0.05) | 67 | 0.08 (−0.01, 0.18) | −0.11 (−0.24, 0.01) | 0.081 | −0.14 | |
12 months b | 67 | −0.08 (−0.18, 0.02) | 57 | 0.04 (−0.08, 0.16) | −0.12 (−0.28, 0.03) | 0.125 | −0.15 | |
18 months | 66 | −0.11 (−0.20, −0.02) | 59 | −0.01 (−0.11, 0.09) | −0.10 (−0.24, 0.03) | 0.124 | −0.13 | |
HDL-cholesterol (mmol/L) | Baseline M (SD) | 78 | 1.4 (0.3) | 78 | 1.4 (0.4) | |||
6 months | 71 | 0.02 (−0.02, 0.07) | 67 | −0.02 (−0.06, 0.03) | 0.04 (−0.02, 0.10) | 0.182 | 0.13 | |
12 months b | 67 | 0.05 (0.00, 0.09) | 57 | −0.01 (−0.06, 0.04) | 0.06 (−0.01, 0.12) | 0.110 | 0.17 | |
18 months | 66 | 0.06 (0.01, 0.11) | 59 | 0.00 (−0.04, 0.05) | 0.06 (−0.01, 0.12) | 0.097 | 0.17 | |
Systolic blood pressure (mmHg) | Baseline M (SD) | 79 | 125.3 (12.2) | 79 | 123.4 (11.3) | |||
6 months | 71 | −1.69 (−4.21, 0.83) | 68 | 3.44 (0.86, 6.02) | −5.13 (−8.73, −1.52) | 0.005 | −0.44 | |
12 months b | 70 | 1.05 (−1.70, 3.80) | 59 | 2.20 (−0.77, 5.17) | −1.15 (−5.20, 2.90) | 0.577 | −0.10 | |
18 months | 68 | 3.07 (−0.37, 6.52) | 59 | 5.54 (1.88, 9.19) | −2.46 (−7.48, 2.56) | 0.336 | −0.21 | |
Diastolic blood pressure (mmHg) | Baseline M (SD) | 79 | 78.7 (9.4) | 79 | 77.9 (7.3) | |||
6 months | 71 | −0.35 (−2.03, 1.32) | 68 | 2.40 (0.69, 4.12) | −2.76 (−5.15, −0.36) | 0.024 | −0.33 | |
12 months b | 70 | 0.60 (−1.07, 2.27) | 59 | 1.51 (−0.29, 3.30) | −0.90 (−3.36, 1.55) | 0.470 | −0.11 | |
18 months | 68 | 1.06 (−0.80, 2.92) | 59 | 3.39 (1.41, 5.36) | −2.33 (−5.04, 0.39) | 0.093 | −0.28 | |
Fasting plasma glucose (mmol/L) | Baseline M (SD) | 78 | 5.5 (1.2) | 78 | 5.6 (1.1) | |||
6 months | 71 | −0.34 (−0.49, −0.19) | 67 | −0.21 (−0.36, −0.05) | −0.13 (−0.35, 0.08) | 0.230 | −0.11 | |
12 months b | 67 | −0.17 (−0.32, −0.03) | 57 | 0.06 (−0.10, 0.21) | −0.23 (−0.44, −0.02) | 0.032 | −0.20 | |
18 months | 66 | −0.12 (−0.29, 0.04) | 59 | −0.10 (−0.27, 0.08) | −0.02 (−0.26, 0.22) | 0.844 | −0.02 |
Outcome | Timepoint | Intervention | Usual Care | Intervention Effect (Intervention—Usual Care) | ||||
---|---|---|---|---|---|---|---|---|
n | Mean Change (95% CI) | n | Mean Change (95% CI) | Mean Difference (95% CI) | p | d a | ||
QOL Physical Health component (T score) b | Baseline M (SD) | 78 | 44.8 (6.9) | 77 | 45.9 (6.6) | |||
6 months | 69 | 2.43 (1.31, 3.56) | 65 | 0.46 (−0.70, 1.62) | 1.98 (0.36, 3.59) | 0.017 | 0.29 | |
12 months c | 65 | 3.16 (1.82, 4.50) | 58 | 0.50 (−0.90, 1.91) | 2.66 (0.71, 4.60) | 0.007 | 0.39 | |
18 months | 65 | 1.56 (0.13, 2.99) | 57 | 0.38 (−1.13, 1.89) | 1.18 (−0.90, 3.26) | 0.266 | 0.18 | |
QOL Mental Health component (T score) b | Baseline M (SD) | 78 | 46.1 (7.2) | 77 | 45.5 (6.3) | |||
6 months | 69 | 1.34 (0.10, 2.57) | 65 | −0.17 (−1.44, 1.10) | 1.51 (−0.27, 3.28) | 0.097 | 0.22 | |
12 months c | 65 | 1.98 (0.68, 3.28) | 58 | 0.21 (−1.15, 1.58) | 1.77 (−0.12, 3.66) | 0.067 | 0.26 | |
18 months | 65 | −0.36 (−1.98, 1.26) | 57 | 0.17 (−1.54, 1.88) | −0.53 (−2.89, 1.83) | 0.659 | −0.08 | |
Fatigue b | Baseline M (SD) | 77 | 35.5 (9.7) | 77 | 37.6 (9.5) | |||
6 months | 68 | 3.21 (1.57, 4.86) | 65 | 0.75 (−0.94, 2.43) | 2.47 (0.11, 4.83) | 0.040 | 0.26 | |
12 months c | 64 | 4.29 (2.57, 6.01) | 58 | 2.26 (0.46, 4.05) | 2.03 (−0.46, 4.53) | 0.110 | 0.21 | |
18 months | 63 | 2.63 (0.81, 4.46) | 57 | 1.99 (0.09, 3.89) | 0.65 (−2.00, 3.29) | 0.632 | 0.07 | |
Musculoskeletal Pain | Baseline M (SD) | 63 | 1.5 (1.1) | 59 | 1.6 (1.0) | |||
6 months | 56 | −0.21 (−0.44, 0.02) | 50 | 0.40 (0.16, 0.64) | −0.61 (−0.94, −0.28) | <0.001 | −0.58 | |
12 months c | 52 | −0.19 (−0.42, 0.04) | 46 | 0.32 (0.08, 0.56) | −0.51 (−0.84, −0.18) | 0.003 | −0.49 | |
18 months | 53 | −0.07 (−0.32, 0.18) | 44 | 0.26 (−0.01, 0.52) | −0.33 (−0.69, 0.04) | 0.079 | −0.31 | |
Menopausal Symptoms—Psychological subscale | Baseline M (SD) | 75 | 10.0 (6.2) | 76 | 9.6 (5.7) | |||
6 months | 66 | −1.40 (−2.51, −0.30) | 65 | −0.14 (−1.25, 0.98) | −1.27 (−2.84, 0.30) | 0.113 | −0.21 | |
12 months c | 62 | −1.90 (−3.20, −0.60) | 58 | −0.62 (−1.96, 0.71) | −1.28 (−3.14, 0.59) | 0.179 | −0.22 | |
18 months | 61 | −1.24 (−2.54, 0.06) | 56 | −0.22 (−1.56, 1.12) | −1.02 (−2.88, 0.85) | 0.286 | −0.17 | |
Menopausal Symptoms—Somatic subscale | Baseline M (SD) | 76 | 5.5 (4.3) | 76 | 5.1 (4.0) | |||
6 months | 67 | −0.67 (−1.31, −0.04) | 65 | 0.58 (−0.07, 1.22) | −1.25 (−2.15, −0.34) | 0.007 | −0.30 | |
12 months c | 62 | −0.77 (−1.53, −0.01) | 58 | −0.07 (−0.85, 0.71) | −0.70 (−1.79, 0.39) | 0.206 | −0.17 | |
18 months | 63 | −0.67 (−1.47, 0.13) | 56 | 0.27 (−0.56, 1.10) | −0.94 (−2.10, 0.21) | 0.108 | −0.23 | |
Menopausal Symptoms—Vasomotor subscale | Baseline M (SD) | 76 | 2.6 (2.2) | 76 | 2.4 (2.1) | |||
6 months | 67 | 0.24 (−0.13, 0.62) | 65 | 0.49 (0.11, 0.87) | −0.25 (−0.78, 0.29) | 0.367 | −0.12 | |
12 months c | 63 | 0.06 (−0.36, 0.48) | 58 | 0.42 (−0.02, 0.85) | −0.35 (−0.96, 0.25) | 0.250 | −0.17 | |
18 months | 63 | −0.22 (−0.65, 0.21) | 56 | 0.32 (−0.13, 0.77) | −0.54 (−1.16, 0.08) | 0.089 | −0.25 | |
Fear of Cancer Recurrence | Baseline M (SD) | 77 | 14.5 (9.6) | 76 | 15.5 (9.7) | |||
6 months | 68 | −2.20 (−3.74, −0.65) | 64 | −1.08 (−2.67, 0.51) | −1.12 (−3.34, 1.10) | 0.321 | −0.12 | |
12 months c | 64 | −2.24 (−3.83, −0.65) | 57 | −3.35 (−5.02, −1.67) | 1.11 (−1.21, 3.42) | 0.348 | 0.12 | |
18 months | 64 | −2.45 (−4.24, −0.65) | 55 | −1.99 (−3.91, −0.07) | −0.46 (−3.08, 2.17) | 0.734 | −0.05 | |
Body Image—Total score | Baseline M (SD) | 78 | 2.8 (0.6) | 77 | 2.7 (0.6) | |||
6 months | 69 | −0.35 (−0.46, −0.24) | 65 | −0.14 (−0.25, −0.03) | −0.21 (−0.37, −0.05) | 0.010 | −0.36 | |
12 months c | 65 | −0.43 (−0.54, −0.32) | 58 | −0.25 (−0.36, −0.13) | −0.18 (−0.35, −0.02) | 0.030 | −0.31 | |
18 months | 65 | −0.30 (−0.42, −0.17) | 57 | −0.21 (−0.35, −0.08) | −0.08 (−0.27, 0.10) | 0.380 | −0.14 |
Intervention (n = 11 Participants) | No. of Events | Usual Care (n = 10 Participants) | No. of Events | |
---|---|---|---|---|
Life-threatening (n = 4) a | Stage IV breast cancer (bone metastasis) | 1 | Heart episode during surgery | 1 |
Stage IV breast cancer (i.e., bone metastasis, site unknown) | 2 | |||
Severe/undesirable (n = 21) b | Musculoskeletal events requiring hospitalization or surgery | 6 c | Musculoskeletal events requiring hospitalization or surgery | 1 |
Genitourinary events requiring hospitalization or surgery | 4 | Gastrointestinal events requiring hospitalization or surgery | 1 | |
Other events requiring hospitalization or surgery | 1 | Genitourinary events requiring hospitalization or surgery | 2 | |
Local breast cancer recurrence | 1 | Respiratory events requiring hospitalization or surgery | 3 | |
Other events requiring hospitalization or surgery | 2 |
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Reeves, M.M.; Terranova, C.O.; Winkler, E.A.H.; McCarthy, N.; Hickman, I.J.; Ware, R.S.; Lawler, S.P.; Eakin, E.G.; Demark-Wahnefried, W. Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial. Nutrients 2021, 13, 4091. https://doi.org/10.3390/nu13114091
Reeves MM, Terranova CO, Winkler EAH, McCarthy N, Hickman IJ, Ware RS, Lawler SP, Eakin EG, Demark-Wahnefried W. Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial. Nutrients. 2021; 13(11):4091. https://doi.org/10.3390/nu13114091
Chicago/Turabian StyleReeves, Marina M., Caroline O. Terranova, Elisabeth A. H. Winkler, Nicole McCarthy, Ingrid J. Hickman, Robert S. Ware, Sheleigh P. Lawler, Elizabeth G. Eakin, and Wendy Demark-Wahnefried. 2021. "Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial" Nutrients 13, no. 11: 4091. https://doi.org/10.3390/nu13114091