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

doi:10.1016/j.cct.2022.107009

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

Preventive Medicine

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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 language	English (US)
Article number	107009
Journal	Contemporary Clinical Trials
Volume	123
DOIs	https://doi.org/10.1016/j.cct.2022.107009
State	Published - Dec 2022

Funding

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. This work was funded by the National Institutes of Health ( R37CA248774 ). We thank all the participants in the study who make this research possible.

Keywords

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

ASJC Scopus subject areas

Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.cct.2022.107009

Cite this

Kenfield, S. A., Philip, E. J., Phillips, S. M., Meyerhardt, J. A., Chan, J. M., Atreya, C. E., Kim, M. O., Harris, Q., Steiding, P., Macaire, G., McCullough, M. L., Piawah, S., Johnson, W. Y., Kurttila, F. A., Lewis, W. L., Pesmen, C., Watson, Y., & Van Blarigan, E. L. (2022). Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit): Study protocol of a randomized factorial experiment. Contemporary Clinical Trials, 123, Article 107009. https://doi.org/10.1016/j.cct.2022.107009

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

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.",

keywords = "Colorectal cancer, Multiphase optimization strategy framework (MOST), Nutrition, Physical activity, Survivorship, Weight loss",

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

note = "Publisher Copyright: {\textcopyright} 2022 The Authors",

year = "2022",

month = dec,

doi = "10.1016/j.cct.2022.107009",

language = "English (US)",

volume = "123",

journal = "Contemporary Clinical Trials",

issn = "1551-7144",

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}

Kenfield, SA, Philip, EJ, Phillips, SM, Meyerhardt, JA, Chan, JM, Atreya, CE, Kim, MO, Harris, Q, Steiding, P, Macaire, G, McCullough, ML, Piawah, S, Johnson, WY, Kurttila, FA, Lewis, WL, Pesmen, C, Watson, Y & Van Blarigan, EL 2022, 'Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit): Study protocol of a randomized factorial experiment', Contemporary Clinical Trials, vol. 123, 107009. https://doi.org/10.1016/j.cct.2022.107009

Optimizing intervention tools to improve nutrition and physical activity for colorectal cancer survivors (Tools To Be Fit): Study protocol of a randomized factorial experiment. / Kenfield, Stacey A.; Philip, Errol J.; Phillips, Siobhan M. et al.
In: Contemporary Clinical Trials, Vol. 123, 107009, 12.2022.

Research output: Contribution to journal › Article › peer-review

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.

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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DO - 10.1016/j.cct.2022.107009

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SN - 1551-7144

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JO - Contemporary Clinical Trials

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ER -

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

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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