scholarly journals Dietary Modification and Breast Cancer Mortality: Long-Term Follow-Up of the Women’s Health Initiative Randomized Trial

2020 ◽  
Vol 38 (13) ◽  
pp. 1419-1428 ◽  
Author(s):  
Rowan T. Chlebowski ◽  
Aaron K. Aragaki ◽  
Garnet L. Anderson ◽  
Kathy Pan ◽  
Marian L. Neuhouser ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Dietary Fat ◽  
Dietary Intervention ◽  
Breast Cancer Incidence ◽  
Intervention Group ◽  
Dietary Modification ◽  
Fat Intake ◽  
Health Initiative

PURPOSE Observational studies of dietary fat intake and breast cancer have reported inconsistent findings. This topic was addressed in additional analyses of the Women’s Health Initiative (WHI) Dietary Modification (DM) clinical trial that evaluated a low-fat dietary pattern influence on breast cancer incidence. METHODS In the WHI DM trial, 48,835 postmenopausal women, ages 50-79 years, with no prior breast cancer, and a dietary fat intake of ≥ 32% of energy were randomly assigned at 40 US centers to a usual diet comparison group (60%) or dietary intervention group (40%). The goals were to reduce fat intake to 20% of energy and increase vegetable, fruit, and grain intake. Breast cancers were confirmed after central medical record review and serial National Death Index linkages to enhance mortality findings. RESULTS During 8.5 years of dietary intervention, breast cancer incidence and deaths as a result of breast cancer were nonsignificantly lower in the intervention group, while deaths after breast cancer were statistically significantly lower both during intervention and through a 16.1-year (median) follow-up. Now, after a long-term, cumulative 19.6-year (median) follow-up, the significant reduction in deaths after breast cancer persists (359 [0.12%] v 652 [0.14%] deaths; hazard ratio [HR], 0.85; 95% CI, 0.74 to 0.96; P = .01), and a statistically significant reduction in deaths as a result of breast cancer (breast cancer followed by death attributed to the breast cancer) emerged (132 [0.037%, annualized risk] v 251 [0.047%] deaths, respectively; HR, 0.79; 95% CI, 0.64 to 0.97; P = .02). CONCLUSION Adoption of a low-fat dietary pattern associated with increased vegetable, fruit, and grain intake, demonstrably achievable by many, may reduce the risk of death as a result of breast cancer in postmenopausal women.

Low-fat dietary pattern and long-term breast cancer incidence and mortality: The Women’s Health Initiative randomized clinical trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 520-520 ◽  
Author(s):  
Rowan T. Chlebowski ◽  
Aaron K Aragaki ◽  
Garnet L Anderson ◽  
Kathy Pan ◽  
Marian L Neuhouser ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Dietary Pattern ◽  
Dietary Intervention ◽  
Breast Cancer Incidence ◽  
Intervention Group ◽  
Fat Intake ◽  
Breast Cancers ◽  
Low Fat ◽  
Cancer Breast

520 Background: Observational studies of dietary fat intake and breast cancer have inconsistent findings. To address this issue, the Women’s Health Initiative (WHI) Dietary Modification (DM) clinical trial assessed a low-fat dietary pattern influence on breast cancer incidence and outcome. Methods: The WHI DM trial is a randomized, controlled clinical trial conducted at 40 US centers, where 48,835 postmenopausal women, aged 50-79 years, with no previous breast cancer and dietary fat intake ≥32% of total energy, were randomly assigned, from 1993-1998, to a usual diet comparison group (60%) or dietary intervention group (40%) with goals to reduce fat intake to 20% of energy and increase vegetables, fruit, and grain intake. This study is registered as: NCT00000611. Results: The dietary intervention significantly reduced fat intake; increased fruit, vegetable and grain intake with modest weight loss (3%) (all P< 0.001). During 8.5 years of dietary intervention, there were 8% fewer breast cancers and deaths from breast cancer were somewhat lower in the intervention group but the rates were not significantly different. However, deaths after breast cancer (breast cancer followed by death from any cause) were significantly reduced in the intervention group, both during intervention (hazard ratio [HR] 0·65 95% confidence interval [CI] 0·45-0·95) and through 16.1 year (median) cumulative follow-up. Now, after long- term, cumulative 19.6 year (median) follow-up, with 3,374 incident breast cancers, the significant reduction in deaths after breast cancer continued (with 1,011 deaths, HR 0·85 95% CI 0·74-0·96) and a significant reduction in deaths from breast cancer (breast cancer followed by death attributed to the breast cancer) emerged (with 383 deaths, HR 0·79 95% CI 0·64-0·97). Conclusions: Adoption of a low-fat dietary pattern associated with increased vegetable, fruit, and grain intake, demonstrably achievable by many, significantly reduced the risk of death from breast cancer in postmenopausal women. To our review, these findings provide the first randomized clinical trial evidence that a dietary change can reduce a postmenopausal woman’s risk of dying from breast cancer. Clinical trial information: NCT00000611.

scholarly journals Low-Fat Dietary Pattern among Postmenopausal Women Influences Long-Term Cancer, Cardiovascular Disease, and Diabetes Outcomes

2019 ◽  
Vol 149 (9) ◽  
pp. 1565-1574 ◽  
Author(s):  
Ross L Prentice ◽  
Aaron K Aragaki ◽  
Barbara V Howard ◽  
Rowan T Chlebowski ◽  
Cynthia A Thomson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Dietary Fat ◽  
Dietary Pattern ◽  
Cancer Colorectal ◽  
Comparison Group ◽  
Intervention Group ◽  
Intervention Period ◽  
Low Fat

ABSTRACT Background The preferred macronutrient dietary composition, and the health consequences of dietary fat reduction specifically, have been debated for decades. Here we provide a comprehensive overview of long-term health outcomes in the Women's Health Initiative Dietary Modification (DM) trial. Objective The DM trial aimed to examine whether a low-fat dietary pattern would reduce the risk of invasive breast cancer, colorectal cancer, and, secondarily, coronary heart disease (CHD), with various other health outcomes also considered. Methods The DM trial is a randomized controlled trial conducted at 40 centers in the US, among 48,835 postmenopausal women aged 50–79 y with baseline intake of ≥32% energy from fat. Participants were randomly assigned to a low-fat dietary pattern intervention group or to a usual-diet comparison group, during 1993–1998. Intervention goals were to reduce fat intake from ∼35% to 20% of total energy, in conjunction with increasing vegetables and fruit to 5 servings/d and grains to 6 servings/d. Results Over an 8.5-y (median) intervention period, intervention and comparison group differences included lower fat by 8–10%, and higher carbohydrate by 8–10%, of total energy, in conjunction with higher consumption of vegetables, fruit, and grains. Time-to-outcome analyses did not show significant differences between intervention and comparison groups for invasive breast cancer, colorectal cancer, or CHD, either over the intervention period or over longer-term cumulative follow-up. Additional analyses showed significant intervention group benefits related to breast cancer, CHD, and diabetes, without adverse effects. Over a 19.6-y (median) follow-up period, HRs (95% CIs) were 0.84 (0.74, 0.96) for breast cancer followed by death, and 0.87 (0.77, 0.98) for diabetes requiring insulin. Conclusions Reduction in dietary fat with corresponding increase in vegetables, fruit, and grains led to benefits related to breast cancer, CHD, and diabetes, without adverse effects, among healthy postmenopausal US women. This trial was registered at clinicaltrials.gov as NCT00000611.

scholarly journals Low-Fat Dietary Pattern and Breast Cancer Mortality in the Women’s Health Initiative Randomized Controlled Trial

2017 ◽  
Vol 35 (25) ◽  
pp. 2919-2926 ◽  
Author(s):  
Rowan T. Chlebowski ◽  
Aaron K. Aragaki ◽  
Garnet L. Anderson ◽  
Cynthia A. Thomson ◽  
JoAnn E. Manson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Dietary Pattern ◽  
Dietary Intervention ◽  
Dietary Group ◽  
Fat Intake ◽  
Breast Cancers ◽  
Low Fat ◽  
Health Initiative ◽  
Usual Diet

Purpose Earlier Women’s Health Initiative Dietary Modification trial findings suggested that a low-fat eating pattern may reduce breast cancers with greater mortality. Therefore, as a primary outcome-related analysis from a randomized prevention trial, we examined the long-term influence of this intervention on deaths as a result of and after breast cancer during 8.5 years (median) of dietary intervention and cumulatively for all breast cancers diagnosed during 16.1 years (median) of follow-up. Patients and Methods The trial randomly assigned 48,835 postmenopausal women with normal mammograms and without prior breast cancer from 1993 to 1998 at 40 US clinical centers to a dietary intervention with goals of a reduction of fat intake to 20% of energy and an increased intake of fruits, vegetables, and grains (40%; n = 19,541) or to a usual diet comparison (60%; n = 29,294). Results In the dietary group, fat intake and body weight decreased (all P < .001). During the 8.5-year dietary intervention, with 1,764 incident breast cancers, fewer deaths occurred as a result of breast cancer in the dietary group, which was not statistically significant (27 deaths [0.016% per year] v 61 deaths [0.024% per year]; hazard ratio [HR], 0.67; 95% CI, 0.43 to 1.06; P = .08). During the same period, deaths after breast cancer (n = 134) were significantly reduced (40 deaths [0.025% per year] v 94 deaths [0.038% per year]; HR, 0.65; 95% CI, 0.45 to 0.94; P = .02) by the dietary intervention. During the 16.1-year follow-up, with 3,030 incident breast cancers, deaths after breast cancer also were significantly reduced (234 deaths [0.085% per year] v 443 deaths [0.11% per year]; HR, 0.82; 95% CI, 0.70 to 0.96; P = .01) in the dietary group. Conclusion Compared with a usual diet comparison group, a low-fat dietary pattern led to a lower incidence of deaths after breast cancer.

Dietary intervention influence on physical activity in the Women’s Health Initiative randomized Dietary Modification trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 10511-10511
Author(s):  
Kathy Pan ◽  
Aaron K. Aragaki ◽  
Yvonne Michael ◽  
Cynthia A. Thomson ◽  
Aladdin H. Shadyab ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Physical Activity ◽  
Physical Inactivity ◽  
Regression Models ◽  
Dietary Intervention ◽  
Comparison Group ◽  
Activity Level ◽  
Dietary Modification ◽  
Health Initiative

10511 Background: In the Women’s Health Initiative (WHI) Dietary Modification (DM) randomized trial, after 8.5 years dietary intervention and 19.5 years cumulative (median) follow-up, dietary intervention participation was associated with a statistically significantly 22% lower breast cancer mortality (P = 0.02). In observational studies, physical activity has been associated with lower breast cancer risk with emerging results now indicating, compared to inactivity, any increase in physical activity has health benefits. Currently, longitudinal data on whether an intervention targeting dietary change influences other health-related behaviors as a gateway effect is limited. To evaluate whether randomization to a dietary intervention was associated with self-directed change in physical activity. Methods: In the WHI DM trial, 48,835 postmenopausal women, ages 50-79 years, with no prior breast cancer and baseline normal mammogram were randomized at 40 US clinical centers to a dietary intervention (19,541) or a comparison group. Dietary goals were to reduce fat intake to 20% of energy and increase intake of vegetable, fruit, and grains addressed in 18 group sessions in year 1 then quarterly. Neither randomization group received specific or ongoing instructions to increase physical activity, but physical activity was referenced in written materials given to the intervention groups in 7 of the 56 sessions. Episodes per week of moderate or vigorous recreational physical activity (MVPA) were collected at baseline and serially through 15.9 years follow-up by self-report questionnaire. Marginal longitudinal logistic regression models were used to assess physically inactive (MVPA = 0) or physically active (MVPA > 0) participants by randomization group. Marginal Poisson regression models estimated mean weekly MVPA by randomization group. Results: 45.6% of participants reported 0 MVPA at baseline which largely persisted throughout follow-up. During cumulative follow-up, relative to the comparison group, dietary intervention group participation was associated with 7% lower physical inactivity rate (odds ratio [OR] 0.93 95% confidence interval [CI] 0.91, 0.95, P < 0.001) and a 4% higher mean MVPA (ratio of means [RM] 1.04 95% CI 1.02, 1.06, P < 0.001). The association between dietary intervention participation with higher physical activity level was stronger with increasing BMI (P-interaction 0.01) and for women with waist circumference ≥ 88 cm (P-interaction 0.02). Conclusions: In conclusion, in a randomized trial setting, a low-fat dietary pattern intervention was associated with a significantly lower physical inactivity rate and significantly higher moderate and vigorous physical activity level which could be associated with health benefits. Clinical trial information: NCT00000611 .

scholarly journals Low-Fat Dietary Pattern and Cancer Mortality in the Women’s Health Initiative (WHI) Randomized Controlled Trial

2018 ◽  
Vol 2 (4) ◽  
Author(s):  
Rowan T Chlebowski ◽  
Garnet L Anderson ◽  
JoAnn E Manson ◽  
Ross L Prentice ◽  
Aaron K Aragaki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Women's Health ◽  
Cancer Mortality ◽  
Dietary Pattern ◽  
Dietary Intervention ◽  
Low Fat ◽  
Women's Health Initiative ◽  
Health Initiative ◽  
The Women’S Health Initiative

Abstract Background In the Women’s Health Initiative Dietary Modification trial, a low-fat dietary pattern reduced deaths after breast cancer. Mortality from other cancer sites has not been reported. Methods A low-fat dietary pattern influence on deaths from and after site-specific cancers was examined during 8.5 years (median) of dietary intervention and cumulatively during 17.7 years (median) of follow-up. A total 48 835 postmenopausal women, ages 50–79 years, were randomly assigned from 1993 to 1998 at 40 US clinical centers to dietary intervention (40%, n = 19 541 or a usual diet comparison group (60%, n = 29 294). Dietary intervention influence on mortality from protocol-specified cancers (breast, colon and rectum, endometrium and ovary), individually and as a composite, represented the primary analyses. Results During the dietary intervention period, a reduction in deaths after breast cancer (HR = 0.65 95% CI = 0.45 to 0.94, P = .02) was the only statistically significant cancer mortality finding. During intervention, the HRs for deaths after the protocol-specified cancer composite were 0.90 (95% CI = 0.73 to 1.10) and 0.95 (95% CI = 0.85 to 1.06) for deaths after all cancers. During 17.7 years of follow-up with 3867 deaths after all cancers, reduction in deaths after breast cancer continued in the dietary intervention group (HR = 0.85, 95% CI = 0.74 to 0.99, P = .03). However, no dietary intervention influence on deaths from or after any other cancer or cancer composite was seen. Conclusions A low-fat dietary pattern reduced deaths after breast cancer. No reduction in mortality from or after any other cancer or cancer composite was seen.

Brief relaxation training effects on long-term endocrine therapy adherence among women with breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12061-12061
Author(s):  
Molly Ream ◽  
Emily A Walsh ◽  
Jamie M. Jacobs ◽  
Natasha Schaefer Solle ◽  
Steven A. Safren ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Relaxation Training ◽  
Intervention Group ◽  
Equation Modeling ◽  
Future Research ◽  
Management Interventions ◽  
Long Term Follow Up

12061 Background: Despite life-saving potential, many women struggle to adhere to adjuvant endocrine therapy (AET) for their early-stage, hormone receptor-positive breast cancer. Prior research has demonstrated that emotional distress is a barrier to AET adherence. The current study aimed to test the long-term effects of two 5-week post-surgical group-based stress management interventions, cognitive behavioral therapy (CBT) and relaxation training (RT), versus an attention-matched health education (HE) control on AET adherence at long-term follow-up. Methods: We conducted long-term follow-up (median = 8 years, range = 7-11 years) of a cohort of women who enrolled in a randomized controlled trial of CBT vs. RT vs. HE shortly after surgery for stage 0-3 breast cancer.We measuredadherence with the Endocrine Therapy Medication Usage Questionnaire (ETMUQ) given at long-term follow-up. First, we established adherence factors on the ETMUQ via confirmatory factor analysis. We then used structural equation modeling to regress these factors on study arm, controlling for patient age, stage of disease, and treatments received (chemotherapy/radiation). Results: The sample was predominately middle-aged ( M= 54.81, SD= 10.19), White (41.5%) and Hispanic (42.2%), partnered (62.2%) with stage 1 (57.0%) or stage 2 (25.9%) disease. Of the women who completed long-term follow-up (N = 59, 44.7% of original sample); more than half (n = 30; 50.8%) reported having at least some problems with adherence. There was an effect of intervention group on adherence, such that women receiving RT (n = 15) had significantly better adherence than those receiving CBT (n = 20) on the factor measuring Forgetfulness/Inconsistency ( B(SE) =.57 (.34), p=.001), and marginally better adherence than those receiving CBT on the factor measuring Intentional Nonadherence ( B(SE) =.60 (.33), p =.062). There was no such effect when comparing RT or CBT to HE (n = 24). Conclusions: Women receiving RT were less likely to forget to take their AET and marginally less likely to intentionally miss doses of AET in the long-term compared to women receiving CBT. Future research could investigate the mechanism by which RT may improve adherence. For example, RT may reduce somatic symptoms related to AET or improve a patients’ self-efficacy to cope with these symptoms thereby reducing intentional non-adherence. In addition, RT may improve patients’ attention and awareness leading to less forgetfulness. Clinical trial information: NCT02103387.

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