title: Evaluation of pedometry as a patient-centered outcome in patients undergoing hematopoietic cell transplant (HCT): a comparison of pedometry and patient reports of symptoms, health, and quality of life.
abstract: OBJECTIVE
  We evaluated pedometry as a novel patient-centered outcome because it enables passive continuous assessment of activity and may provide information about the consequences of symptomatic toxicity complementary to self-report.
  
  
  METHODS
  Adult patients undergoing hematopoietic cell transplant (HCT) wore pedometers and completed PRO assessments during transplant hospitalization (4 weeks) and 4 weeks post-discharge. Patient reports of symptomatic treatment toxicities (single items from PRO-CTCAE, http://healthcaredelivery.cancer.gov/pro-ctcae ) and symptoms, physical health, mental health, and quality of life (PROMIS(®) Global-10, http://nih.promis.org ), assessed weekly with 7-day recall on Likert scales, were compared individually with pedometry data, summarized as average daily steps per week, using linear mixed models.
  
  
  RESULTS
  Thirty-two patients [mean age 55 (SD = 14), 63 % male, 84 % white, 56 % autologous, 43 % allogeneic] completed a mean 4.6 (SD = 1.5, range 1-8) evaluable assessments. Regression model coefficients (β) indicated within-person decrements in average daily steps were associated with increases in pain (β = -852; 852 fewer steps per unit increase in pain score, p < 0.001), fatigue (β = -886, p < 0.001), vomiting (β = -518, p < 0.01), shaking/chills (β = -587, p < 0.01), diarrhea (β = -719, p < 0.001), shortness of breath (β = -1018, p < 0.05), reduction in carrying out social activities (β = 705, p < 0.01) or physical activities (β = 618, p < 0.01), and global physical health (β = 101, p < 0.001), but not global mental health or quality of life.
  
  
  CONCLUSIONS
  In this small sample of HCT recipients, more severe symptoms, impaired physical health, and restrictions in the performance of usual daily activities were associated with statistically significant decrements in objectively measured daily steps. Pedometry may be a valuable outcome measure and validation anchor in clinical research.
authors.affiliation: Department of Health Policy and Management, University of North Carolina at Chapel Hill, Campus Box 7411, Chapel Hill, NC, 27599, USA. avbenn@unc.edu.|Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7295, Chapel Hill, NC, 27599, USA. avbenn@unc.edu.
authors.forename: Antonia V
authors.initials: AV
authors.lastname: Bennett
authors.affiliation: Department of Health Policy and Management, University of North Carolina at Chapel Hill, Campus Box 7411, Chapel Hill, NC, 27599, USA.|Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7295, Chapel Hill, NC, 27599, USA.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, Campus Box 7305, Chapel Hill, NC, 27599, USA.|Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7295, Chapel Hill, NC, 27599, USA.
authors.forename: Ethan M
authors.initials: EM
authors.lastname: Basch
authors.affiliation: Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, 9609 Medical Center Drive, East Tower, Room 3-448, Rockville, MD, 20850, USA.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, Campus Box 7305, Chapel Hill, NC, 27599, USA.|Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7295, Chapel Hill, NC, 27599, USA.
authors.forename: Mathew
authors.initials: M
authors.lastname: Meeneghan
authors.affiliation: Department of Exercise and Sports Science, University of North Carolina at Chapel Hill, Campus Box 8700, Chapel Hill, NC, 27599, USA.|Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7295, Chapel Hill, NC, 27599, USA.
authors.forename: Claudio L
authors.initials: CL
authors.lastname: Battaglini
authors.affiliation: Department of Exercise and Sports Science, University of North Carolina at Chapel Hill, Campus Box 8700, Chapel Hill, NC, 27599, USA.
authors.forename: Abbie E
authors.initials: AE
authors.lastname: Smith-Ryan
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7295, Chapel Hill, NC, 27599, USA.
authors.forename: Brett
authors.initials: B
authors.lastname: Phillips
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, Campus Box 7305, Chapel Hill, NC, 27599, USA.|Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7295, Chapel Hill, NC, 27599, USA.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Shea
authors.affiliation: Department of Medicine, University of North Carolina at Chapel Hill, Campus Box 7305, Chapel Hill, NC, 27599, USA.|Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Campus Box 7295, Chapel Hill, NC, 27599, USA.
authors.forename: William A
authors.initials: WA
authors.lastname: Wood
mesh_terms: D061725:Accelerometry; D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000368:Aged; D003430:Cross-Sectional Studies; D005260:Female; D005500:Follow-Up Studies; D006305:Health Status Indicators; D018380:Hematopoietic Stem Cell Transplantation / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D063868:Patient Outcome Assessment; D011788:Quality of Life; D057566:Self Report; D055815:Young Adult
keywords: Fitbit; Hematopoietic cell transplant; Oncology; PRO-CTCAE; PROMIS Global-10; Pedometry; Validation