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Journal of Clinical Oncology, Vol 25, No 19 (July 1), 2007: pp. 2709-2718 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.10.7094 Main Outcomes of the FRESH START Trial: A Sequentially Tailored, Diet and Exercise Mailed Print Intervention Among Breast and Prostate Cancer Survivors
From the Duke School of Nursing, Duke Comprehensive Cancer Center, Duke Center for Aging, and Departments of Surgery, Medicine, Community and Family Medicine, and Psychiatry, Duke University Medical Center; Veterans Affairs Medical Center, Durham, NC; Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, CA; and the Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD Address reprint requests to Wendy Demark-Wahnefried, PhD, Box 3322 Duke University Medical Center, Durham, NC 27710; e-mail: demar001{at}mc.duke.edu
Purpose Cancer survivors are at increased risk for cardiovascular disease, diabetes, osteoporosis, and second primary tumors. Healthful lifestyle practices may improve the health and well-being of survivors. The FRESH START trial tested the efficacy of sequentially tailored versus standardized mailed materials on improving cancer survivors’ diet and exercise behaviors. Methods Five hundred forty-three individuals with newly diagnosed locoregional breast or prostate cancer were recruited from 39 states and two provinces within North America. Participants were randomly assigned either to a 10-month program of tailored mailed print materials promoting fruit and vegetable (F&V) consumption, reducing total/saturated fat intake, and/or increasing exercise or to a 10-month program of nontailored mailed materials on diet and exercise available in the public domain. Telephone surveys conducted at baseline and 1 year assessed body mass index (BMI), dietary consumption, physical activity, and other psychosocial/behavioral indices. Clinical assessments were conducted on a 23% subsample; information was used to validate self-reports. Results Five hundred nineteen participants completed the 1-year follow-up (4.4% attrition; sample characteristics: 57 ± 10.8 years old, 83% white, 56% female, 64% overweight/obese, and 0% underweight). Although both arms significantly improved their lifestyle behaviors (P < .05), significantly greater gains occurred in the FRESH START intervention versus the control arm (practice of two or more goal behaviors: +34% v +18%, P < .0001; exercise minutes per week: +59.3 v +39.2 minutes, P = .02; F&V per day: +1.1 v +0.6 servings, P = .01; total fat: –4.4% v –2.1%, P < .0001; saturated fat: –1.3% v –0.3%, P < .0001; and BMI: –0.3 v +0.1 kg/m2, respectively, P = .004). Conclusion Mailed material interventions, especially those that are tailored, are effective in promoting healthful lifestyle changes among cancer survivors. Further study is needed to determine sustainability, cost to benefit, and generalizability to other cancer populations.
In the United States, a diagnosis of breast or prostate cancer is rendered almost every minute.1 The good news is that most of these patients will be diagnosed with early-stage disease, for which 5-year relative survival rates exceed 98%.1,2 The bad news is that cancer survivors are at increased risk for secondary cancers and other chronic conditions, such as cardiovascular disease, osteoporosis, and functional decline.2-15 A healthful diet and regular exercise can reduce cancer survivors’ comorbidities,2,4,7,16-19 and new evidence suggests that healthful lifestyle practices can protect against recurrence and cancer-specific mortality.20-24 Furthermore, the cancer diagnosis provides a teachable moment, or a time when motivation for lifestyle change is especially high.7,25-27 However, hospital-based programs have limited appeal for this older and geographically dispersed population.17,18,25,28 Instead, home-based mailed print interventions are most preferred,25,28 are likely to be well accepted, and also may be more cost effective than one-on-one counseling or group classes. The FRESH START trial aimed to improve the diet and exercise practices of newly diagnosed breast and prostate cancer survivors and tested the efficacy of a sequentially tailored mailed print intervention against standardized health education materials.29 The central hypothesis was that the tailored intervention would promote significantly greater changes in behavior and higher proportional attainment of at least two of the following behavioral goals: 150+ min/wk of moderate to vigorous exercise; consumption of five or more servings of fruits and vegetables (F&V) a day; and restriction of total and saturated fat to less than 30% and 10% of energy intake, respectively.29,30
Study Design The FRESH START trial design and methods were published previously.29 This behavioral intervention study was a randomized, single-blind, parallel group, attention control and active treatment controlled phase II clinical trial with a 10-month treatment phase and a blinded poststudy follow-up at 1 year. The study was conducted from July 2002 to October 2005, approved by the Duke University Medical Center Institutional Review Board, and reported according to Consolidated Standards of Reporting Trials guidelines.31
Study Population
Measures Data were collected largely via telephone interview, with physical measures (phlebotomy, height, and weight) performed on a 23% subsample of patients residing within 60 miles of Duke University Medical Center to validate self-reported data. Two computer-assisted telephone interviews of 45 to 55 minutes each were conducted with participants at baseline and at follow-up; interviews were scheduled 1 year apart to reduce confounding as a result of seasonality.34-37 The 7-Day Physical Activity Recall38,39 and the Diet History Questionnaire40,41 were administered, and output specific to the practice of goal behaviors was used to evaluate intervention success (ie, minutes per week of moderate, hard, or very hard physical activity of at least 5 metabolic equivalents [kcal/kg/h] pursued for the purpose of fitness, number of F&V servings per day, and % kcal from fat and saturated fat). At these time points, we also assessed quality of life42,43; risk for depression44; social support45; comorbidity46; perceived health47; self-efficacy for exercising 150+ min/wk, eating five or more servings of F&V a day, and eating a low-fat diet48; stage of readiness for undertaking dietary and exercise change 49; tobacco use50; and weight status. Sociodemographic information, cancer coping style,51 and barriers to exercise and eating a low-fat, high-F&V diet were assessed only at baseline. Data related to adverse events were collected continuously via participant report to a toll-free number and were systematically elicited during the year 1 survey; events were categorized by a committee blinded to random assignment status as serious (life threatening, permanently debilitating, or requiring hospitalization overnight) or nonserious (all other events). Participants’ opinions regarding the helpfulness of specific intervention materials in promoting behavior change (5-point Likert scale from completely to not at all helpful) were also assessed at the year 1 follow-up. Measured heights and weights were performed on the 23% subsample at both time points using a wall-mounted stadiometer and a calibrated platform scale; weight status was expressed as body mass index (BMI; kg/m2). Phlebotomy was performed after a fast of 4+ hours; blood samples were protected from light and centrifuged within 1 hour of collection. Plasma was stored at –80°C until batch analyzed for the following: total and high-density lipoprotein cholesterol and high-sensitivity C-reactive protein using a Hitachi 911 clinical analyzer with standard chemistries by Roche Diagnostics (Indianapolis, IN); insulin via radioimmunoassay (Linco, St Charles, MO); and interleukin-6 via enzyme-linked immunosorbent assay (Invitrogen, Carlsbad, CA).52 Alpha-carotene and other carotenoids were quantified using the high-performance liquid chromatography method originally described by Bieri et al53 and subsequently modified and described in detail by Gamboa-Pinto et al.54
Random Assignment
Interventions FRESH START intervention (experimental arm). Participants in this arm received workbooks and newsletters that were individually tailored on barriers, stage of readiness, and progress toward goal attainment of exercising 150+ min/wk, eating five or more servings of F&V a day, or restricting total and saturated fat intakes to less than 30% and 10% of kcal, respectively29; cancer coping style51; and basic demographic characteristics (age, race, and sex).56 Information from brief mailed surveys was used to tailor the newsletters, such that participants received continually updated feedback. Each participant received two 5-month modules on F&V, dietary fat restriction, or exercise; participants only received materials in areas where they did not meet goal behavior; modules were presented one at a time to allow participants time and opportunity to gain needed skills before tackling behavior change in another area. Participants not practicing any goal behaviors at baseline were randomly assigned to two of the three modules. The FRESH START intervention was based on Social Cognitive Theory that emphasizes confidence building and skills development48; the Transtheoretical Model also was used to frame messages on participants’ stage of readiness to motivate behavior change.49 Figure 2 features an illustration of the FRESH START intervention materials (People Designs, Durham, NC).
Standardized intervention (attention control arm). Participants assigned to this arm received a personalized workbook that included the "Facing Forward" booklet (National Cancer Institute) and, in subsequent mailings, additional health education materials on a healthful diet and exercise available in the public domain.29
Statistical Analysis Arm difference in the percentage of patients achieving goal behavior was tested with the logistic regression model. Arm difference in number of behaviors practiced at goal level was tested with the ordinal logistic regression model, controlling for number of behaviors practiced at baseline. Arm differences on continuous outcomes measured at 12 months were tested with the general linear model, controlling for the baseline value of the outcome. Intraclass correlation coefficients were used to examine the agreement between self-reported and clinically assessed BMI, and Spearman correlation coefficients were used to examine the association between alpha-carotene from self-reported dietary intake and plasma levels, partialling out plasma cholesterol levels to achieve lipid-adjusted values. Alpha-carotene was specifically selected for analysis because previous studies have shown stronger correlations with diet and responsiveness to F&V interventions.58,59
Participant Disposition Of the 2,155 cancer patients identified, 83.6% were approved for contact. Several oncologists reported that the Health Insurance Portability and Accountability Act precluded them from referring patients despite a protocol that was compliant with the Health Insurance Portability and Accountability Act.60 Of the 1,789 patients (14 patients had unusable addresses) contacted for study, 42% expressed an interest in participating and submitted consent forms and screening surveys. Respondents differed significantly from nonrespondents with respect to age (58 v 62 years, respectively; P < .0001), race (19% v 38% minority, respectively; P < .0001), and sex (54% v 46% female, respectively; P = .001). Of the respondents screened, 29% were ineligible; leading reasons for exclusion were the current practice of healthful lifestyle behaviors (accounting for 62% of ineligibility) and cardiopulmonary conditions that precluded unsupervised exercise (accounting for 25% of ineligibility; Fig 1). The overall Recruitment Index (mean number of days to accrue and randomly assign each participant) was 1.42 days; Recruitment Indexes for various subgroups were as follows: white breast cancer survivors = 2.45 days; white prostate cancer survivors = 3.61 days; minority breast cancer survivors = 11.60 days; and minority prostate cancer survivors 30.60 days.61 Trial participants were recruited from 39 states and two provinces within North America (Fig 3). Participants were generally white, married, and college educated (Table 1). Most participants were ascertained from cancer registries and had stage I or II cancers that were treated with surgery. Roughly equal numbers of breast and prostate cancer survivors were represented, with most exhibiting fatalistic cancer coping styles51 and moderate numbers of comorbidities. At baseline, roughly half of our sample practiced goal behavior in one domain, with the consumption of five or more servings of F&V most likely to be practiced. Most participants were very to extremely confident that they could make changes in their diet and exercise behaviors, with most being in the preparation or action stages of readiness.
Adherence, Attrition, and Adverse Events All participants received the assigned intervention materials. Of the seven brief surveys interspersed between intervention mailings, completion rates were 5.2 ± 2.4 surveys in the intervention arm and 6.1 ± 1.8 surveys in the control arm (P < .0001). Intervention participants who completed more interim surveys had higher proportional goal attainment; survey completion rates averaged 5.9 v 5.1 surveys among participants achieving two or more goal behaviors versus participants achieving fewer goals, respectively (P = .005). No differences in survey completion rates were observed over time or between modules. Overall, an exceptionally low attrition rate (4.4%) was observed. Attrition did not differ by age, race, sex, or educational status; however, significant differences were observed between arms (6.6% in the intervention arm v 2.2% in the attention control arm, P = .01). No differences in adverse events were observed between arms; intervention participants reported 137 total events (35 serious and 102 nonserious), and attention control participants reported 142 total events (39 serious and 103 nonserious).
Change in the Primary End Point
Change in Secondary End Points The attention control arm experienced significant increases (P < .05) in exercise and F&V consumption and decreases in fat intake; however, the intervention arm achieved far greater improvements (Table 2). The intervention arm also had much greater improvements in diet quality. Participants’ ratings of the helpfulness of materials in motivating their behavior change differed between arms, with 32% to 61% (depending on the behavior) of intervention participants reporting that the tailored workbook and newsletters were quite a bit or completely helpful (compared with not at all, a little, or somewhat helpful) and 34% to 50% of these participants reporting that the tailored surveys also provided them with motivation. In the attention control arm, rated helpfulness for standardized brochures and surveys was 19% to 31% and 18% to 26%, respectively. Little change in quality of life was observed for either arm over the study period; however, baseline levels were high. Although the numbers of smokers were small, a trend (P = .10) toward decreased smoking was observed in the intervention arm. Although the intervention was not aimed at weight loss, a healthful diet and exercise are helpful in regulating body weight.29,30 At baseline, no participants in the sample were underweight, and 64% were overweight. Significant differences between arms were observed for BMI and the proportion of individuals classified within their ideal weight range (BMI, 18.5 to 24.9 kg/m2).62 Among all participants, 6% (33 of 543 participants) changed BMI categories over the study period, with the intervention arm experiencing significantly more shifts from overweight to normal weight than the control arm (75% v 29%, respectively; P = .01). Intraclass correlations between self-reported and clinically measured BMI were 0.996 (baseline) and 0.994 (follow-up), suggesting an almost perfect correlation. Significant associations also were observed between dietary and plasma alpha-carotene (baseline: r = 0.30, P = .001; follow-up: r = 0.31, P = .001). Small changes in health-related biomarkers were observed over the study period (eg, plasma cholesterol decreased by 5.1 mg/dL in the intervention arm v 0.3 mg/dL in the control arm); however, we were underpowered to detect significant differences within the 23% subsample with regard to total, low-density lipoprotein, and high-density lipoprotein cholesterol, interleukin-6, insulin, and C-reactive protein.
FRESH START is the first reported trial of a distance medicine-based diet and exercise intervention in cancer survivors delivered exclusively via mailed print materials. Data show that the FRESH START intervention was effective in increasing the number of lifestyle behaviors practiced at recommended levels and increasing the weekly number of minutes exercised, daily intake of F&V, and overall diet quality, as well as decreasing intakes of fat and saturated fat. Furthermore, although the intervention was not aimed specifically at weight loss, like the results of the Canadian Diet and Breast Cancer Prevention Study63 and the Women's Intervention Nutrition Study,20 the improvement in diet and exercise behaviors resulted in a significant loss of weight. Data from self-report were solidly supported by objective data for which correlations were either in the range (our correlations between dietary and plasma alpha-carotene were 0.30 to 0.31, P = .001, compared with reported correlations of 0.28 to 0.35, P < .0001)58,59 or surpassed findings of previous studies (our correlations between self-reported and measured BMIs were 0.994 to 0.996, P < .0001, compared with correlations of 0.936 to 0.947, P < .0001, reported in the European Prospective Investigation into Cancer and Nutrition study).64 To date, there have been more than 40 diet and exercise interventions targeting cancer survivors. Most of these studies have been effective in improving lifestyle behaviors, with exercise interventions showing benefit in cardiorespiratory fitness, quality of life, and reduced fatigue and dietary interventions showing reductions in body weight and increased levels of dietary biomarkers, such as carotenoids.7,17,18,65-67 Preliminary findings from the Women's Intervention Nutrition Study suggest that a low-fat diet may be effective in decreasing breast cancer recurrence, especially in women with estrogen receptor–negative disease.20 Thus, the FRESH START intervention is not unique with respect to its reported efficacy. However, it is exceptional from the following standpoints: it targeted survivors of both breast and prostate cancer, whereas most extant trials have targeted only breast cancer survivors; it intervened on multiple behaviors (diet and exercise), whereas most others have focused solely on one behavioral domain; it used a distance medicine-based approach that was delivered exclusively through mailed print materials, whereas most trials have relied on hospital-based programs; and it accrued a North American sample of 543 participants, whereas most trials have accrued smaller samples from one institution. FRESH START also is distinguished by its exceptionally low rate of attrition and the use of an attention control arm that served as a rigorous comparison group. Indeed, the fact that, unlike others,19,30,65,67 we did not observe improvements in quality of life may be explained by positive changes inherent with intervention delivery. Ceiling effects offer another plausible explanation because scores were high at baseline. Another area in which we did not observe significant change was in plasma biomarkers because our effect sizes may have been too small to detect within the 23% subsample. The fact that participants in the attention control arm also made significant positive changes in their behavior suggests that individuals with newly diagnosed cancers are a population eager for lifestyle interventions. Indeed, capitalizing on the teachable moment prompted by a cancer diagnosis has been the subject of many reports,26-28 although more research is needed to determine whether intervention uptake differs between cancer populations and populations with other diseases or between newly diagnosed and long-term survivors. The fact that we saw significant improvements in behaviors with a series of seven standardized brochures and surveys provides evidence that minimal interventions may produce significant changes in behavior. Clearly, the tailored intervention was significantly more effective than standardized materials, and even the brief interim surveys that specifically assessed progress in select behavioral domains were viewed by intervention participants as more helpful than standardized surveys. Moreover, exploratory data suggest that the tailored intervention also may be associated with benefit in health events and body weight status. Future studies are needed that will prospectively and systematically examine health events and health care costs associated with interventions such as FRESH START to determine their potential cost savings. In addition, other channels of delivery should be explored. Interventions delivered via Web-based approaches are a natural extension of this work, especially because we found that 80% of the sample had Internet access at the time of the follow-up survey. FRESH START had limitations that should be considered when interpreting its findings. First, although the trial had excellent uptake and accrued participants throughout North America, the representation of minorities, elders, and those of lower educational attainment was proportionally lower than among the general population. Although findings of a recent review of 28 lifestyle intervention trials among cancer survivors suggests that more than two thirds of trials have minority representation of less than 10%, it is notable that FRESH START achieved a greater degree of diversity.68 However, recruitment of minorities was a challenge for us as well and reduces the external validity of our findings. Differential dropout between study arms (ie, 6.6% in the intervention arm and 2.2% in the attention control arm) served as another limitation. However, given that our overall attrition was exceedingly low (less than half the average rate of 13.3%),68 this is less of an issue. Among the 13 intervention participants who discontinued follow-up, one of the primary reasons for dropout was that the participant "just couldn't comply" with the diet or exercise regimen and "felt guilty" about being in the study (a feeling that may have been exacerbated by the intermittent surveys that asked about their health behavior practices). Thus, this study might have benefited from upfront instructions that emphasized the importance of follow-up over that of adherence. Another limitation is the discrepancy in measurement windows of the Diet History Questionnaire and the 7-Day Physical Activity Recall (1 year v 1 week, respectively), although the foremost consideration in selecting these instruments was validity, reliability, and sensitivity to behavioral change, rather than consistency in measurement window.38-41 Finally, more objective biomarker data on a larger subset would have been desirable, as would have been prospectively collected documentation of health care costs. Future studies are needed that will collect such information and that will test similar interventions in other samples of cancer survivors, especially among elders, minorities, and so on. Also, comparison of interventions delivered via various modalities (eg, computer based) is needed to ascertain optimally effective interventions and those that are most cost effective. Newly diagnosed cancer survivors are a vulnerable population who are eager to pursue healthful lifestyle change. Home-based interventions may offer a superior channel in terms of acceptance and cost effectiveness for this geographically dispersed and relatively older population. FRESH START, a 10-month intervention of sequentially tailored print mailed materials, was effective at improving the diet and exercise behaviors of cancer survivors. Further studies are needed to assess the durability of such interventions, to prospectively measure associated cost to benefit, and to test print mailed material approaches against others that offer additional cost savings (eg, Web-based interventions).
The author(s) indicated no potential conflicts of interest.
Conception and design: Wendy Demark-Wahnefried, Elizabeth C. Clipp, Isaac M. Lipkus, David Lobach, Denise Clutter Snyder, Richard Sloane, Bercedis Peterson, Jennifer M. Macri, Colleen M. McBride, William E. Kraus Financial support: Wendy Demark-Wahnefried, Elizabeth C. Clipp, Isaac M. Lipkus, David Lobach, Bercedis Peterson, Colleen M. McBride, William E. Kraus Administrative support: Wendy Demark-Wahnefried, Denise Clutter Snyder Provision of study materials or patients: Wendy Demark-Wahnefried, Isaac M. Lipkus, David Lobach, William E. Kraus Collection and assembly of data: Wendy Demark-Wahnefried, David Lobach, Denise Clutter Snyder, Richard Sloane, Jennifer M. Macri, Cheryl L. Rock Data analysis and interpretation: Wendy Demark-Wahnefried, Elizabeth C. Clipp, Isaac M. Lipkus, David Lobach, Denise Clutter Snyder, Richard Sloane, Bercedis Peterson, Cheryl L. Rock, Colleen M. McBride, William E. Kraus Manuscript writing: Wendy Demark-Wahnefried, Elizabeth C. Clipp, Isaac M. Lipkus, David Lobach, Denise Clutter Snyder, Richard Sloane, Bercedis Peterson, Jennifer M. Macri, Cheryl L. Rock, Colleen M. McBride, William E. Kraus Final approval of manuscript: Wendy Demark-Wahnefried, Elizabeth C. Clipp, Isaac M. Lipkus, David Lobach, Denise Clutter Snyder, Richard Sloane, Bercedis Peterson, Jennifer M. Macri, Cheryl L. Rock, Colleen M. McBride, William E. Kraus
In addition to funding provided by the National Institutes of Health, the Susan Komen Foundation, and the American Institute for Cancer Research, we thank members of the FRESH START Advisory Board, Drs Marci Campbell, Harvey Cohen, Bethany Jackson, P. Kelly Marcom, Bess Marcus and Thomas Polascik, and Barbara Parker, Rachel Schanberg, MS, and the late Russell Ward for their guidance in areas of design and implementation. We are grateful for the contributions and professionalism demonstrated by the staff of People Designs, Inc (David Farrell, MPH, Jetze Beers, Marley Beers, MFA, and Kristin Trangsrud, MPH) who helped craft the FRESH START intervention materials; Dr Cecelia and Len Doak of Patient Learning Associates, Inc who helped make them easily understandable; and NexCura, a Thomson business (Seattle, WA) who posted this trial to their patient listing. Furthermore, we thank scientists in the Stedman Center's Metabolomics Lab (Drs James Bain, Brett R. Wenner, and Robert D. Stevens, and Lauren C. Naliboff) who analyzed our plasma samples. We also thank the following individuals who have contributed expertise and support: Sreenivas Algoti, MS, Teresa Baker, Wendy Brown, Luisa Eisen, Rita Freeman, Sonya Goode Green, MPH, Robert Hollowell, MD, Linda Hofbauer, Heather MacDonald, Paige Miller, Shelley Rusincovitch, and Valeda Stull. We also are grateful to our participating institutions (Duke University Medical Center, Durham Regional Hospital, Durham Veterans Affairs Medical Center, Maria Parham Hospital, New Hanover Regional Medical Center, Raleigh Community Hospital, Rex Healthcare, and the University of Chicago) and cancer registrars/patient care coordinators (Gloria Adams, Renee Gooch, Blanche Sellars, Dortch Smith, Donna Thompson, and Cheri Willard). We also are indebted to the 445 referring physicians: Drs Victor E. Abraham, Anjana Acharya, David Albala, Alex Althausen, Everett Anderson, Roger F. Anderson, Mitchell Anscher, Guillermo Arana, Carlos Arcangelli, Sucha Asbell, Ann Aspera, Michael Aspera, James N. Atkins, Cheryl Aylesworth, Margaret Barnes, Brian Bauer, Louis Baumann, Michael Beall, Gregory Bebb, Michael Beecher, John Bell, Marc Benevides, Brian C. Bennett, Robert Bennett, Robert Bennion, James Benton, Stuart Bergman, William R. Berry, Kelly Blair, Kimberly Blackwell, Gayle Blouin, Peter Blumencranz, William Bobbitt III, Daniel Borison, William Bouchelle, Elaine Bouttell, Don Boychuk, Barb Boyer, Albert Brady, Thomas Brammer, Scott Brantley, Joanna Brell, Charles Brendler, Thomas Brennan, Donald Brennan, Elizabeth Brew, Thomas Bright, Philip Brodak, Dieter Bruno, Dale Bryansmith, Niall Buckley, Walter W. Burns, W. Woodrow Burns, Thomas Buroker, Barbara Burtness, Amanullah Buzdar, David Caldwell, Elizabeth E. Campbell, Susan Campos, Sean Canale, Woodward Cannon, Dominick Carbone, Albert Casazza, George Case, Michael Cashdollar, Stanton Champion, Nitin Chandramouli, Marie Chenn, S. Chew, Stephen Chia, Warren Chin, Richard Chiulli, Elaine Chottiner, Walter Chow, Peter Clark, Kenneth Collins, Barry Conway, Suzanne Conzen, David Cook, John Corman, Shawn Cotton, D. Scott Covington, Edwin B. Cox, Jeffrey Crane, Frank Critz, Nancy J. Crowley, Sam Currin, Brian Czernieki, Brian Czito, Bruce Dalkin, John T. Daniel, John Danneberger, Leroy Darkes, Glenn Davis, Michael Davis, Walter E. Davis, Jean de Kernion, Pat DeFusco, Fletcher Derrick, Margaret Deutsch, Gayle Dilalla, Robert Diloreto, Craig Donatucci, Michael Donovan, John Doster, Bradford Drury, Paul Dudrick, William Dunlap, Edward Eigner, Maha Elkordy, Matthew Ellis, Richard Evans, Jerry Fain, Anne Favret, Ira Fenton, Dirk Fisher, James Foster, Wyatt Fowler, Jeffrey Freeland, Daniel Frenning, Ralf Freter, Michael Frontiera, Michele Gadd, Anthony Galanos, Ronald Garcia, Antonio Gargurevich, Helen Garson, Richard Gavigan, Morris Geffen, Gregory Georgiade, Ward Gillett, Paul Gilman, Jeffrey Gingrich, Deborah Glassman, John Gockerman, Richard Goodjoin, J. Phillip Goodson, Joel Goodwin, Teong Gooi, Jeffrey Gordon, Narender Gorukanit, James Gottesman, Lav Goyal, William Graber, Margaret Gradison, Gordon Grado, Mark Graham, Michael Grant, Stephen Greco, Carl Greene, Peter Grimm, Nima Grissom, Irina Gurevich, Carol Hahn, Alex Haick, Craig Hall, Edward Halperin, Sabah Hamad, R. Erik Hartvigsen, Harold Harvey, Paul Hatcher, James Hathorn, Robert Hathorn, Carolyn Hendricks, David Hesse, Martin Hightower, Peter Ho, Leroy Hoffman, Frankie Ann Holmes, Sidney Hopkins, Samuel Huang, Robert Huben, Cliff Hudis, Thelma Hurd, Sally Ingram, Philip Israel, Naresh Jain, Nora Jaskowiak, Jean Joseph, Jacqueline Joyce, Walton Joyner, Ray Joyner, Scott Kahn, Sachin Kamath, Carsten Kampe, Michael Kane, Richard Kane, Michael Kasper, Uday Kavde, Thomas Keeler, Douglas Kelly, Michael Kent, Kevin Kerlin, Kenneth Kern, Huathin Khaw, Jay Kim, Houston Kimbrough, Charmaine Kim-Sing, John Kishell, Petras Kisielius, Arthur Klose, George Kmetz, Lawrence Knott, Ronald Konchanin, Cyrus Kotwall, Kenneth Kotz, Charles Kraus, Bruce Kressel, Alan Kritz, John Lacey, Susan Laing, David Larson, John Lasater, Barry Lee, W. Robert Lee, Douglas Leet, Natasha Leighl, George Leight, Paul LeMarbre, Herbert Lepor, Seth Lerner, Margaret Levy, Lori Lilley, Steve Limentani, Robert Lineberger, Lenis Livesay, Walter Loehr, Fred J. Long, Richard Love, Mark Lucas, James Lugg, Charles Lusch, H. Kim Lyerly, Janet Macheledt, Thomas Maddox, Patrick Maguire, Mark Makhuli, Rajeev Malik, Mary Manascalco-Theberge, P. Kelly Marcom, Manfred Marcus, Neal Mariados, Lawrence Marks, Shona Martin, Eric Matayoshi, Gordon Mathes, Mark McClure, Scott McGinnis, David McLeod, Warren McMurry, William McNulty, Robert McWilliams, Cynthia Menard, Mani Menon, Richard Michaelson, Michael Mikolajczyk, David Miles, Dixie Mills, Jesse Mills, David Mintzer, David Molthorp, Allen Mondzac, Gustavo Montana, Angelica Montesano, Leslie Montgomery, Joseph O. Moore, William Morgan, Patricia Morrison, Michael A. Morse, Jacek Mostwin, Judd Moul, Ziyad Mugharbil, Brian Murphy, William Muuse, J. William Myers, Richard S. Myers, Richard Mynatt, Gene Naftulin, Vishwanath Nagale, Niam Nazha, Charles Neal, James Neidhart, Joseph D. Neighbors, Philip Newhall, Robert Nichols, William Niedrach, Peter Oh, John Oh, John A. Olson, Robert Ornitz, David Ornstein, Alexander Panutich, Maria Papaspyrou, Steven Papish, Dhaval Parikh, James Parsons, George Paschal, Robert Paterson, Dev Paul, David F. Paulson, Samuel Peretsman, Jorge Perez, Mark Perman, Thomas Phillips, Thomas Polascik, Klaus Porzig, David C. Powell, Kenneth Prebil, Glenn Preminger, Adele Preto, Leonard Prosnitz, Robert Prosnitz, Scott K. Pruitt, Michael Pryor, Milton Quigless, Robert Reagan, Carl Reese, C.F. Reid, John Reilly, Robert Renner, Alan Rice, Melvin Richter, John Rickabaugh, Adrien Rivard, Ralph Roan, Cary Robertson, Steve Robeson, Linda Robinson, Mark Romer, Eric Rosen, Amy Rosenthal, Alison Ross, William Russell, Lewis Russell, Charles Scarantino, Candace Schiffer, Mark Schoenberg, Mark Scholz, William Schuessler, Stuart Schwartzberg, Janell Seeger, Victoria Seewaldt, Hillard Seigler, Pearl Seo, Phillip Shadduck, Timothy Shafman, Rohit Shah, Arieh Shalhav, Peter Shapiro, Fred Shapiro, Heather Shaw, Robert Siegel, Daniel Silver, Mary Simmonds, Jane Skelton, Barbara Smith, Mitchell Sokoloff, Douglas Sorensen, Angela Soto-Hamlin, Alexander Sparkuhl, Thomas Spears, Merle Sprague, Mark St. Lezin, Steven J. Stafford, B. Dino Stea, Gary Steinberg, Patricia Steinecker, Mary Stewart, Jerry Stirman, Lewis Stocks, Scott Stoioff, Christopher Stokoe, Warren Streisand, Mark Sturdivant, Paul Sugar, Steven Sukh, Steven Sukin, Perry Sutaria, Linda Sutton, Phillip Sutton, John Sylvester, Beth Szuck, Darrell Tackett, Ernesto Tan, Sharon Taylor, John Taylor, Dina Tebcherany, Chris Teigland, Marcos Tepper, Haluk Tezcan, William Thoms, Ellis Tinsley, Jr., Lisa Tolnitch, Angel Torano, Frank Tortora, William Truscott, Theodore Tsangaris, Peter Tucker, Walter Tucker, Ingolf Tuerk, Wade Turlington, Richard Tushman, Michael Tyner, Pascal Udekwu, Eric Uhlman, Henry Unger, Linda Vahdat, Louis Vandermolen, George Vassar, Margaret Vereb, Johannes Vieweg, Daniel Vig, Tom Vo, Walter Vogel, David Wahl, B. Alan Wallstedt, Patrick Walsh, Philip Walther, Robert Waterhouse, Charles Wehbie, Seth Weinreb, Marissa Weiss, Raul Weiss, Geoffrey White, Edward Whitesides, Lee Wilke, Hamilton Williams, Matthew Wilner, Don Wilson, James S. Wilson, Bristol Winslow, Rachel Wissner, James Wolf, Lawrence Womack, Charles Woodhouse, Clifford Yaffe, Daniel Yao, Richard Yelverton, Lemuel Yerby, Mark Yoffe, Martin York, Gregory Zagaja, Kenneth Zeitler, Elizabeth Zubek, and Raul Zunzunegui). Most of all, we are indebted to the many cancer survivors who helped us pilot test, retest, and then formally test the intervention.
Supported by Grants No. CA81191, CA74000, CA63782, and M01-RR-30 from the National Institutes of Health and also by the American Institute of Cancer Research and the Susan G. Komen Foundation (W.D.-W.). Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
