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 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 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.

Low-fat dietary pattern and breast cancer mortality by metabolic syndrome degree: Secondary analyses of the Women’s Health Initiative (WHI) Dietary Modification randomized trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1539-1539
Author(s):  
Kathy Pan ◽  
Aaron K Aragaki ◽  
Marian L Neuhouser ◽  
Michael S. Simon ◽  
Juhua Luo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metabolic Syndrome ◽  
Waist Circumference ◽  
Cancer Mortality ◽  
Dietary Intervention ◽  
Comparison Group ◽  
Breast Cancer Mortality ◽  
Low Fat ◽  
Hazard Ratios

1539 Background: The WHI Diet Modification (DM) trial randomized 48,835 postmenopausal women with no prior breast cancer to a low-fat dietary intervention or comparison group. After 16.1 years follow-up, the intervention was associated with an 18% reduction in risk of death after breast cancer (P =0.01), with greater reduction (29%) in those with waist circumference≥88 cm (J Clin Oncol 2017). To extend these findings, we examined the influence of the dietary intervention on breast cancer mortality in subgroups defined by number of metabolic syndrome (MS) components with 19.6 years median cumulative follow-up. Methods: WHI DM has been previously described. Four MS components were determined at entry: 1) waist circumference≥ 88 cm, 2) high blood pressure or anti-hypertensive use, 3) high cholesterol history and 4) diabetes history, with women categorized as having 0 (n=10,639), 1-2 (n=30,948), or 3-4 (n=4,246) MS components. Forest plots of hazard ratios (HRs) were generated with P-values for interaction between randomized group assignment and number of MS components. Results: Women with 3-4 MS components were more likely to be Black, be obese (BMI ≥30), and have diabetes (all P < 0.001). Breast cancers in women with 3-4 MS components were less likely to be local stage (P = 0.005) or well differentiated (P = 0.03). The magnitude of reduction in deaths from breast cancer in the dietary intervention vs comparison group increased as the number of MS components increased (interaction P = 0.01). Hazard ratios (HR) and 95% confidence intervals (CI) for death from breast cancer for intervention vs comparison groups for women with 0 MS components was 1.09 95% CI, 0.63-1.87, with risk low in both randomization groups (0.028% and 0.026%, respectively); for women with 1-2 MS components, HR 0.80 95% CI 0.62-1.02; and for women with 3-4 MS components, HR 0.31 95% CI, 0.14-0.69, with risk in the intervention group reduced to 0.026%. Conclusions: Adoption of a low-fat dietary pattern had a greater effect on reducing deaths from breast cancer in women with more MS components, suggesting that this is a high risk group more likely to benefit from the dietary intervention. Clinical trial information: NCT00000611.

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.

Long-term effects of a job search intervention for transition-age youth with visual impairments

2021 ◽  
pp. 1-15
Author(s):  
Jennifer L. Cmar ◽  
Michele C. McDonnall
Keyword(s):  
Job Search ◽  
Self Efficacy ◽  
Comparison Group ◽  
Visual Impairments ◽  
Intervention Group ◽  
Search Behavior ◽  
Long Term Effects ◽  
Job Search Behavior

BACKGROUND: Research supports the short-term benefits of a job search intervention for youth with visual impairments, but its effectiveness over time has not been explored. OBJECTIVE: We examined the long-term effects of a research-based job search intervention on job search knowledge, job search behavior, job search self-efficacy, and employment outcomes. METHODS: We conducted a longitudinal study with 92 youth with visual impairments using a two-group, quasi-experimental repeated-measures design. The intervention group received 35–40 hours of job search skills training, and the comparison group received usual services. Data collection included telephone surveys at pretest, posttest, 8-month follow-up, and 14-month follow-up. RESULTS: Intervention group participants had increases in job search knowledge, job search behavior, and job search behavior self-efficacy at posttest; they maintained increases in knowledge and self-efficacy, but not behavior. Comparison group participants also had increases in job search behavior and job search behavior self-efficacy at the end of the study. Changes in job search outcomes self-efficacy were not evident for either group; neither were differences in post-intervention employment. CONCLUSIONS: The intervention had lasting effects on job search knowledge, but findings for other outcomes over time were mixed. Both groups had low employment rates throughout the study.

Training overweight/obese older women at high risk for breast cancer to use web-based weight loss tools: The HELP pilot study.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 233-233 ◽  
Author(s):  
L. A. Cadmus Bertram ◽  
J. P. Pierce ◽  
R. E. Patterson ◽  
H. Ojeda-Fournier ◽  
V. A. Newman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Physical Activity ◽  
Weight Loss ◽  
Pilot Study ◽  
Comparison Group ◽  
Intervention Group ◽  
Initial Weight ◽  
Web Based ◽  
Internet Users

233 Background: Excess weight is one of the few modifiable risk factors for incident breast cancer. Many programs can achieve a 7% weight loss but few can maintain it over time. Training women to use self-help resources over the internet has potential for reducing intervention costs and ensuring program maintenance. Methods: 50 overweight/obese (BMI≥27.5 kg/m2) women at increased risk of breast cancer (Gail score≥1.7) were identified from a mammography registry and enrolled in the HELP pilot study and randomized with 2:1 probability to a 12-week lifestyle intervention or a comparison group. Twelve telephone-based coaching calls trained participants to use a free, publicly available website to set goals and track performance for dietary intake and physical activity. The comparison group received information but no training. At baseline and 12 weeks, participants were weighed, fitted with an accelerometer for physical activity pattern, and completed questionnaires. Results: At baseline, participants were 60.9±0.79 years of age with a BMI of 33.1±0.60 kg/m2; 39% were daily internet users. Thirty-three were randomized to the intervention group with 91% completing follow-up. Fifty-four percent were able to use the website reliably and found it to be helpful, including 44% of previously nondaily internet users. At 12 weeks, intervention group participants who found the website helpful had lost 5.6±0.7 kg, or 6.7% of initial weight, intervention participants who did not find it helpful lost 0.8±0.9kg or 1.1% of initial weight and the comparison group gained 1.0±0.94 kg (89% follow-up) The between-group difference weight change was 4.2 kg (p<.0001). 74% of intervention group participants lost weight, compared to only 34% of women assigned to the comparison group. Conclusions: A 12-session telephone coaching program to train women to use publicly available web-based weight loss programs effectively achieved a large short-term weight loss among the majority of participants. Further follow-up is needed to identify how well the initial weight loss is maintained without further intervention assistance.

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.

scholarly journals Annual mammographic screening to reduce breast cancer mortality in women from age 40 years: long-term follow-up of the UK Age RCT

2020 ◽  
Vol 24 (55) ◽  
pp. 1-24
Author(s):  
Stephen Duffy ◽  
Daniel Vulkan ◽  
Howard Cuckle ◽  
Dharmishta Parmar ◽  
Shama Sheikh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Confidence Interval ◽  
Relative Rate ◽  
Intervention Group ◽  
Mammographic Screening ◽  
Control Group ◽  
Breast Cancers ◽  
National Programme

Background There remains disagreement on the long-term effect of mammographic screening in women aged 40–49 years. Objectives The long-term follow-up of a randomised controlled trial that offered annual mammography to women aged 40–49 years. The estimation of the effect of these mammograms on breast cancer and other-cause mortality, and the effect on incidence, with implications for overdiagnosis. Design An individually randomised controlled trial comparing offering annual mammography with offering usual care in those aged 40–48 years, and thus evaluating the effect of annual screening entirely taking place before the age of 50 years. There was follow-up for an average of 23 years for breast cancer incidence, breast cancer death and death from other causes. We analysed the mortality and incidence data by Poisson regression and estimated overdiagnosis formally using Markov process models. Setting Twenty-three screening units in England, Wales and Scotland within the NHS Breast Screening Programme. Participants Women aged 39–41 years were recruited between 1990 and 1997. After exclusions, a total of 53,883 women were randomised to undergo screening (the intervention group) and 106,953 women were randomised to have usual care (the control group). Interventions The intervention group was invited to an annual breast screen with film mammography, two view at first screen and single view thereafter, up to and including the calendar year of their 48th birthday. The control group received no intervention. Both groups were invited to the National Programme from the age of 50 years, when screening is offered to all women in the UK. Main outcome measures The main outcome measures were mortality from breast cancers diagnosed during the intervention phase of the trial (i.e. before the first National Programme screen at 50 years), mortality from all breast cancers diagnosed after randomisation, all-cause mortality, mortality from causes other than breast cancer, and the incidence of breast cancer. Results There was a statistically significant 25% reduction in mortality from breast cancers diagnosed during the intervention phase at 10 years’ follow-up (relative rate 0.75, 95% confidence interval 0.58 to 0.97; p = 0.03). No reduction was observed thereafter (relative rate 0.98, 95% confidence interval 0.79 to 1.22). Overall, there was a statistically non-significant 12% reduction (relative rate 0.88, 95% confidence interval 0.74 to 1.03; p = 0.1). The absolute benefit remained approximately constant over time, at one death prevented per 1000 women screened. There was no effect of intervention on other-cause mortality (relative rate 1.02, 95% confidence interval 0.97 to 1.07; p = 0.4). The intervention group had a higher incidence of breast cancer than the control group during the intervention phase of the trial, but incidence equalised immediately on the first National Programme screen at the age of 50–52 years. Limitations There was 31% average non-compliance with screening and three centres had to cease screening for resource and capacity reasons. Conclusions Annual mammographic screening at the age of 40–49 years resulted in a relative reduction in mortality, which was attenuated after 10 years. It is likely that digital mammography with two views at all screens, as practised now, could improve this further. There was no evidence of overdiagnosis in addition to that which already results from the National Programme carried out at later ages. Future work There is a need for research on the effects of modern mammographic protocols and additional imaging in this age group. Trial registration Current Controlled Trials ISRCTN24647151. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 55. See the NIHR Journals Library website for further project information. Other funding in the past has been received from the Medical Research Council, Cancer Research UK, the Department of Health and Social Care, the US National Cancer Institute and the American Cancer Society.

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