title: Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Duke School of Nursing, Duke Comprehensive Cancer Center, and Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA. demar001@mc.duke.edu
authors.forename: Wendy
authors.initials: W
authors.lastname: Demark-Wahnefried
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Clipp
authors.forename: Isaac M
authors.initials: IM
authors.lastname: Lipkus
authors.forename: David
authors.initials: D
authors.lastname: Lobach
authors.forename: Denise Clutter
authors.initials: DC
authors.lastname: Snyder
authors.forename: Richard
authors.initials: R
authors.lastname: Sloane
authors.forename: Bercedis
authors.initials: B
authors.lastname: Peterson
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Macri
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Rock
authors.forename: Colleen M
authors.initials: CM
authors.lastname: McBride
authors.forename: William E
authors.initials: WE
authors.lastname: Kraus
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000401:mortality* / Q000628:therapy*; D004032:Diet; D015444:Exercise; D005081:Exercise Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009656:North America; D052756:Nutritional Sciences; D011471:Prostatic Neoplasms / Q000401:mortality* / Q000628:therapy*; D012306:Risk; D016037:Single-Blind Method; D016896:Treatment Outcome