Susan Faerber

A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: the Women's Healthy Eating and Living (WHEL) Study

The Womens Healthy Eating and Living (WHEL) Study is a multisite randomized controlled trial of the effectiveness of a high-vegetable, low-fat diet, aimed at markedly raising circulating carotenoid concentrations from food sources, in reducing additional breast cancer events and early death in women with early-stage invasive breast cancer (within 4 years of diagnosis). The study randomly assigned 3088 such women to an intensive diet intervention or to a comparison group between 1995 and 2000 and is expected to follow them through 2006. Two thirds of these women were under 55 years of age at randomization. This research study has a coordinating center and seven clinical sites. Randomization was stratified by age, stage of tumor and clinical site. A comprehensive intervention program that includes intensive telephone counseling, cooking classes and print materials helps shift the dietary pattern of women in the intervention. Through an innovative telephone counseling program, dietary counselors encourage women in the intervention group to meet the following daily behavioral targets: five vegetable servings, 16 ounces of vegetable juice, three fruit servings, 30 g of fiber and 15-20% energy from fat. Adherence assessments occur at baseline, 6, 12, 24 or 36, 48 and 72 months. These assessments can include dietary intake (repeated 24-hour dietary recalls and food frequency questionnaire), circulating carotenoid concentrations, physical measures and questionnaires about health symptoms, quality of life, personal habits and lifestyle patterns. Outcome assessments are completed by telephone interview every 6 months with medical record verification. We will assess evidence of effectiveness by the length of the breast cancer event-free interval, as well as by overall survival separately in all the women in the study as well as specifically in women under and over the age of 55 years.

Factors Associated With Weight Gain in Women After Diagnosis of Breast Cancer

OBJECTIVE To identify the factors associated with weight gain after diagnosis of breast cancer in a heterogeneous population of women. DESIGN Descriptive cross-sectional study. SUBJECTS 1,116 patients who had been diagnosed with stage I, stage II, or stage IIIA primary, operable breast cancer within the previous 4 years. Patients were recruited during enrollment into a diet intervention trial to reduce risk for breast cancer recurrence. Analysis Demographic data, weight history, and physical activity information obtained by questionnaire and medical information obtained by chart review; dietary assessment based on four 24-hour dietary recalls collected by telephone. Associations between weight change after the diagnosis of breast cancer and prediction variables were examined using univariate and multiple linear regression analyses. RESULTS Overall, 60% of the subjects reported weight gain, 26% reported weight loss, and 14% reported no change in weight after the diagnosis of breast cancer. The overall mean weight change was a gain of 2.7 kg (6 lb). Factors positively and independently associated with weight gain were time since diagnosis of breast cancer, adjuvant chemotherapy, African-American ethnicity, current energy intake, and postmenopausal status at time of study entry. Factors inversely and independently associated with weight gain were prediagnosis body mass index, age at diagnosis, education level, and exercise index score. APPLICATIONS Higher energy intake and lower level of physical activity are independently associated with increased risk for weight gain after the diagnosis of breast cancer. Strategies to modify these behaviors are likely to influence the long-term pattern of weight change.

Dietary Supplement Use by Women at Risk for Breast Cancer Recurrence

Abstract Objective To develop a method of collecting, organizing, and analyzing information on nutrient and nonnutrient dietary supplement use by women at risk for breast cancer recurrence as a component of nutrition assessment and monitoring, and to describe the characteristics associated with dietary supplement use in this population at enrollment in a clinical trial to prevent breast cancer recurrence. Design Cross-sectional descriptive study design. Subjects Women diagnosed with breast cancer within the previous 4 years (n=435). Analysis Dietary supplements reported in four 24-hour dietary recalls were categorized according to primary nutrient and nonnutrient contents. Prevalence of dietary supplement use is described. Associations between supplement use and demographic and participant characteristics were examined using χ 2 analysis and logistic regression. Results Dietary supplement use was reported by 80.9% of the women. Increased likelihood of supplement use was associated with demographic (eg, older age, higher level of education, white race vs other ethnic groups) and personal (eg, lower body mass index, moderate alcohol consumption) characteristics. Use of vitamin C and related compounds, other nutrients (eg, n-3 fatty acids, evening primrose oil), and herbal products was inversely associated with months since diagnosis; use of miscellaneous supplements (eg, shark cartilage) was directly associated with more advanced stage at diagnosis. Applications Monitoring dietary supplement use is an important aspect of nutrition assessment, especially in populations with chronic health conditions or medical diagnoses. Demographic and personal characteristics, time passed since diagnosis, and stage of cancer at diagnosis are predictive of dietary supplement use by women at risk for breast cancer recurrence. Associations in this population may be present in other groups that are the object of nutrition intervention efforts. J Am Diet Assoc. 1998;98:285-292.

Feasibility of a randomized trial of a high-vegetable diet to prevent breast cancer recurrence.

Epidemiologic evidence supports the concept that diet influences risk for breast cancer and suggests that prognosis after the diagnosis of breast cancer may also be related to modifiable nutritional factors. The purpose of this study was to investigate the feasibility of a randomized trial of a high-vegetable, reduced-fat, and increased-fiber diet intervention to reduce risk for recurrence among breast cancer survivors. This major change in dietary pattern was promoted through intensive telephone counseling. Participants were 93 women who had been diagnosed with breast cancer (stages I, II, and IIIA) within the previous four years and who had completed their initial treatment. We assessed adherence to the study diet using repeated 24-hour dietary recalls at 6 and 12 months and measurement of circulating carotenoid concentrations. Six months after randomization, the intervention group had significantly increased their mean intake of vegetables (+4.6 servings/day), fruit (+0.7 servings/day), and fiber (+6.4 g/1,000 kcal) and significantly reduced their intake of dietary fat (-9.9% of energy) compared with the control group. Circulating concentrations of carotenoids also increased in the intervention group. These changes persisted at the 12-month visit. Results of this study demonstrate that telephone counseling can be a useful approach in diet intervention and that breast cancer survivors can adopt and maintain a high-vegetable, reduced-fat dietary pattern.

Nutrient intakes from foods and dietary supplements in women at risk for breast cancer recurrence

Dietary supplements have been suggested to have a role in cancer prevention and treatment. The purpose of this study was to describe the nutrient intakes from foods and dietary supplements in women at the time of enrollment into a clinical trial to prevent breast cancer recurrence. Subjects were within four years of diagnosis with Stage I, II, or IIIA breast cancer and had completed medical treatment (n = 435). Intakes were assessed with four 24-hour recalls over two weeks. Dietary nutrient intakes in supplement users were compared with intakes in nonusers, and supplement nutrient intakes in participants consuming diets providing < 75% were compared with those in participants consuming > or = 75% of recommended levels. Intakes of participants with diets meeting general guidelines for disease prevention were compared with intakes of those whose diets did not meet these guidelines. Dietary supplement use was reported by 352 (80.9%) of the participants, but frequency of excess intakes did not exceed 5% for all micronutrients examined. Women whose diets provided higher levels of most vitamins and minerals were more likely to obtain additional amounts of these micronutrients from dietary supplements. Participants reporting use of any supplement consumed diets providing more dietary fiber (p < 0.04) and less dietary fat (p < 0.001) than nonusers of any supplement. These results illustrate the importance of monitoring dietary supplement use in clinical trials with a focus on preventing cancer recurrence, because supplements can contribute substantially to nutrient intakes in the population under study.

Correlates of obesity in postmenopausal women with breast cancer: comparison of genetic, demographic, disease-related, life history and dietary factors.

BACKGROUND: Obesity in women has been associated with a variety of factors, including genetic predisposition, social class, early age at menarche, exercise, alcohol consumption and diet. Obesity is a risk factor for the occurrence and the recurrence of breast cancer in postmenopausal women, perhaps because of increased exposure to estrogen, insulin and insulin-like growth factors (IGFs). The progesterone receptor (PR) and the steroid hormone receptor coactivator pCIP/ACTR/AIB1/TRAM1/RAC3 (AIB1) are hypothesized to mediate signaling crosstalk between these hormonal pathways. Polymorphisms in both genes have been described and their association with breast cancer risk reported. If genetic factors contribute to obesity, and the PR and AIB1 genes influence estrogenic, insulin and IGF pathways, then genetic patterns resulting from PR and AIB1 polymorphisms may be associated with obesity in postmenopausal women.OBJECTIVE: We compared the PR and AIB1 genotypes of postmenopausal women with breast cancer with demographic, disease-related, reproductive, lifestyle and dietary variables in terms of the strength of their relationship with obesity (BMI≥30 kg/m2).SUBJECTS: A total of 301 postmenopausal women previously diagnosed with Stage I, II or IIIA breast cancer, who are enrolled in the Womens Healthy Eating and Living (WHEL) study (age: 34.5–70.8 y, BMI: 17.8–54.6 kg/m2).MEASUREMENTS: The PR polymorphism PROGINS was identified by PCR. The length of the AIB1 polyglutamine repeat was determined by PCR and nondenaturing gel electrophoresis or DNA sequencing. BMI was obtained at the baseline clinic visit upon entry into the WHEL study. Information about date of diagnosis, stage of disease, tumor hormone receptor status and adjuvant treatment received were obtained from medical records. Reproductive, menstrual history, demographic, family history of cancer, smoking history and exercise frequency and intensity information were obtained from questionnaires. Dietary and alcohol intake data came from four 24-h telephone recalls of food intake obtained at the study entry.RESULTS: The combined inheritance of PROGINS A1/A1 and AIB1 28/29, 28/30, 28/31, 29/29 or 29/30 (AIB1 LG) genotypes (adjusted odds ratio (OR)=2.22 (95% confidence interval 1.25–3.93)) and early age at menarche (<12 y) (adjusted OR=2.34 (1.12–4.86)) were each associated with the risk for obesity. Current use of tamoxifen (adjusted OR=0.49 (0.28–0.87)) and an alcohol intake ≥10 g/day (adjusted OR=0.28 (0.11–0.77)) were inversely associated with BMI ≥30 kg/m2.CONCLUSION: Early age at menarche and a PROGINS A1/A1+AIB1 LG genetic pattern had comparable levels of association with obesity in this cross-sectional sample of postmenopausal women with breast cancer. Since this was a cross-sectional rather than a case–control design, the association between PROGINS and AIB1 genotype and obesity found in this sample should be considered preliminary, and must be re-evaluated with a new and larger sample.

Timing of Dietary Change in Response to a Telephone Counseling Intervention: Evidence from the WHEL Study

OBJECTIVE Little is known about temporal patterns of diet change within interventions, nor about predictors of early and sustained successful change. Social-cognitive theory asserts that early successes in achieving behavior change increase self-efficacy, leading to longer-term success. DESIGN The authors conducted exploratory cluster analyses using dietary data from the first month of the telephone counseling intervention of the Womens Healthy Eating and Living (WHEL) Study. MAIN OUTCOME MEASURE Change in dietary pattern at three early intervention timepoints. RESULTS Three clusters were identified: Cluster 1 (25%) was close to meeting study goals at baseline, but still made major changes; Cluster 2 (49%) and Cluster 3 (26%) were not achieving study goals at baseline, but Cluster 2 made substantial immediate changes, while Cluster 3 changed their diet more gradually. Baseline demographic and behavioral variables were associated with cluster membership; however, the strongest predictors of cluster were self-efficacy, motivation, and approaches to study goals. Cluster membership predicted dietary pattern at 12 months. CONCLUSION These data suggest that a one-on-one telephone counseling intervention that is intensive in the early weeks may maximize the level of change achieved in a study.

On the importance of using multiple methods of dietary assessment.

Background: Plasma carotenoid concentrations reflect intake of vegetables and fruits, the major food sources of these compounds. This study compared the ability of 2 measures of dietary intake (24-hour diet recalls and food frequency questionnaires [FFQs]) to corroborate plasma carotenoid concentrations in a subset of women participating in a diet intervention trial. Methods: Plasma carotenoid concentrations and dietary intakes, estimated from 24-hour diet recalls and FFQs, were examined at baseline and 1 year later in a subset of 395 study participants (197 intervention and 198 comparison group). We used longitudinal models to examine associations between estimated intakes and plasma carotenoid concentrations. These analyses were stratified by study group and adjusted for body mass index (BMI), plasma cholesterol concentration, and total energy intake. We conducted simulations to compare mean-squared errors of prediction of each assessment method. Results: In mixed-effects models, the estimated carotenoid intakes from both dietary assessment methods were strongly associated with plasma concentrations of α-carotene, β-carotene, and lutein. Furthermore, modeling the 2 sources of intake information as joint predictors reduced the prediction error. Conclusion: These findings underscore the importance of using multiple measures of dietary assessment in studies examining diet–disease associations.

Impact of a clinical care online intake form in a breast care clinic.

137 Background: An online self-reported clinical care intake form was provided to new surgery patients of the Moores UCSD Breast Care Clinic, as part of a pilot project in collaboration with the University of California Athena Breast Health Network. Clinical care goals were 1) to reduce clinic time by pre-visit collection of patient histories, co-morbidities, and medications and 2) provide patient reported data to clinicians and the electronic medical record (EMR). Clinical research goals were to 1) identify individuals diagnosed with breast cancer, 2) collect baseline measures related to co-morbidities, psychosocial parameters, and lifestyle factors and 3) increase research opportunities and enrollment. METHODS We developed an online intake form for patients to complete at home prior to their appointment. Patients were informed to complete the intake form before their appointment and were sent instructions via email. Patients without an email address had the opportunity to complete their intake form on an iPad in clinic. A summary of intake form answers was uploaded into the EMR for all patients. Patients could consent to future contact, to have their intake data kept in a research registry and/or to provide a blood or tissue sample. RESULTS From March 2010 to May 2013, 1,224 sequential new breast surgery clinic patients were contacted to complete the online intake form as part of their clinical care. 890 patients completed the intake form prior to their visit (73%). 802 of the 890 patients consented to contact for future research opportunities (90%) and 624 of the 802 consented to share data and EMR access for research (78%). We have coordinated enrollment with our ongoing UCSD biorepository study and have collected 210 blood and 51 tissue samples. Additionally, using future contact consent, we recruited more than 100 participants to multiple lifestyle and survey-based clinical studies. CONCLUSIONS The use of an online intake form is well accepted by patients and provides patient reported data to all clinicians involved in patient care. In conjunction with consented EMR access, these data can be evaluated routinely for quality and efficiency purposes. Initial consent for future contact greatly facilitates participant recruitment to research studies.

Plant-based Diet and Breast Cancer Recurrence: Report of a Feasibility Study

Abstract LEARNING OUTCOME: To learn whether survivors of early breast cancer would be willing to adopt and maintain an experimental diet considerably higher in plant foods and lower in fat than currently recommended in national dietary guidelines. Epidemiologic and laboratory evidence suggest that a diet rich in vegetables, fruits, and fiber, and low in fat may be able to prevent or delay breast cancer progression. A randomized feasibility study was conducted to determine whether survivors with early breast cancer would be willing to adopt and maintain such a dietary pattern. Subjects were 93 women between the ages of 30 and 70 years. Ambitious behavioral targets for daily consumption were set to achieve the study dietary pattern: 5 servings of vegetables, 2 (8-ounce) servings of fresh vegetable juice, 3 servings of fruit, 30 grams of fiber, and 15% of calories from fat. The control diet was the NCI 9-a-Day diet. Telephone counseling methodology was used to motivate women and assist them in self-regulating their own behavior. Daily counseling was scheduled during the first week, followed by weekly counseling for 10 weeks, and then monthly counseling for the remainder of the first year of the study. Monthly cooking classes were conducted to build social support and to share recipes. We report changes in dietary intake collected from repeated 24-hour recalls (4 within 2 weeks) obtained at baseline, 6, and 12 months using the Nutritional Data System (NDS). Daily intakes of total fiber, beta carotene, vitamin C, folate, and magnesium, taken as a group, are considered a good marker of plant-based food intake. The control group had no significant changes in self-reported consumption of any of these nutrients. The intervention group reported significantly higher (p