TY - JOUR
T1 - Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit)
T2 - Study protocol of a randomized factorial experiment
AU - Kenfield, Stacey A.
AU - Philip, Errol J.
AU - Phillips, Siobhan M.
AU - Meyerhardt, Jeffrey A.
AU - Chan, June M.
AU - Atreya, Chloe E.
AU - Kim, Mi Ok
AU - Harris, Quincy
AU - Steiding, Paige
AU - Macaire, Greta
AU - McCullough, Marjorie L.
AU - Piawah, Sorbarikor
AU - Johnson, Wenora Y.
AU - Kurttila, Florence A.
AU - Lewis, Wendy L.
AU - Pesmen, Curtis
AU - Watson, Yasmeem
AU - Van Blarigan, Erin L.
N1 - Funding Information:
JAM: Dr. Meyerhardt received personal fees for serving on the advisory boards of COTA Healthcare and Merck, and institutional support from Boston Biomedical for a clinical trial outside the submitted work. He also receives financial support from the Douglas Gray Woodruff Chair fund, the Guo Shu Shi Fund, Anonymous Family Fund for Innovations in Colorectal Cancer, and the George Stone Family Foundation.
Funding Information:
This work was funded by the National Institutes of Health ( R37CA248774 ). We thank all the participants in the study who make this research possible.
Publisher Copyright:
© 2022 The Authors
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Colorectal cancer
KW - Multiphase optimization strategy framework (MOST)
KW - Nutrition
KW - Physical activity
KW - Survivorship
KW - Weight loss
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U2 - 10.1016/j.cct.2022.107009
DO - 10.1016/j.cct.2022.107009
M3 - Article
C2 - 36396066
AN - SCOPUS:85142190098
VL - 123
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
M1 - 107009
ER -
