Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit): Study protocol of a randomized factorial experiment

Stacey A. Kenfield, Errol J. Philip, Siobhan M. Phillips, Jeffrey A. Meyerhardt, June M. Chan, Chloe E. Atreya, Mi Ok Kim, Quincy Harris, Paige Steiding, Greta Macaire, Marjorie L. McCullough, Sorbarikor Piawah, Wenora Y. Johnson, Florence A. Kurttila, Wendy L. Lewis, Curtis Pesmen, Yasmeem Watson, Erin L. Van Blarigan*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States. The American Cancer Society (ACS) Nutrition and Physical Activity Guidelines are associated with longer survival among CRC survivors, but few report behaviors consistent with the guidelines. Methods: The Tools To Be Fit study, based on the Multiphase Optimization Strategy (MOST) framework, is a full factorial experimental to optimize a remotely delivered 48-week diet and physical activity intervention for non-metastatic CRC survivors. The intervention includes a core component (booklet and personal report). CRC survivors (N = 400) are additionally randomly assigned to one of 16 combinations of four candidate components, each with 2 options: 1) text messaging (on/off); 2) self-monitoring modality (digital/paper); 3) health coaching (on/off); and 4) support person coaching (on/off). Outcomes: Our primary outcome is adherence to the ACS guidelines after 48 weeks using a score that includes physical activity from accelerometers, dietary intake from a food frequency questionnaire, and body mass index (BMI) measured by a technician. Secondary outcomes include the ACS score after 24 weeks and score components at 24 and 48 weeks. Exploratory outcomes include adherence and change in Social Cognitive Theory constructs. We will explore moderation by sociodemographic, clinical, and psychological/behavioral factors; and change in the ACS score in relation to change in levels of insulin, insulin sensitivity, inflammation, gut microbiome structure, fatigue, depression, and sleep disturbance. Discussion: The proposed study aims to inform a randomized controlled trial to determine whether an optimized intervention reduces risk of recurrence among CRC survivors.

Original languageEnglish (US)
Article number107009
JournalContemporary Clinical Trials
Volume123
DOIs
StatePublished - Dec 2022

Keywords

  • Colorectal cancer
  • Multiphase optimization strategy framework (MOST)
  • Nutrition
  • Physical activity
  • Survivorship
  • Weight loss

ASJC Scopus subject areas

  • Pharmacology (medical)

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