Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Erin Van Blarigan

Description

Summary

This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in colorectal cancer survivors. Studies indicate that people with colorectal cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. The four different intervention components may help patients with colon or rectal cancer adopt recommended health behaviors after they have completed treatment.

Official Title

Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit)

Details

PRIMARY OBJECTIVE: I. To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on change in colorectal cancer (CRC) survivors' American Cancer Society (ACS) guideline score after 48 weeks of intervention. SECONDARY OBJECTIVES: I. To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on CRC survivors' American Cancer Society (ACS) guideline score after 24 weeks of intervention. II. To determine the effect of four candidate intervention components, and combinations of the four intervention components, on CRC survivors' intake of fruits and vegetables, whole grains, refined grains, red meat, and processed meats; moderate-to-vigorous physical activity; and body mass index (BMI) after 48 weeks of intervention. EXPLORATORY OBJECTIVES: I. To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person coaching), and combinations of the four intervention components, on CRC survivors' American Cancer Society (ACS) guideline score after 12 weeks of intervention. II. To describe adherence to each intervention component. III. To explore the effects of each of the candidate intervention components (text messaging, digital health tool kit, health coaching, support person training) on theoretical constructs (e.g., self-efficacy, outcome expectations, self monitoring, social support) from 0 to 24 and 48 weeks. IV. To explore whether sociodemographic (e.g., gender, age, race/ethnicity), clinical (e.g., stage of disease, treatment history, ostomy status, time since diagnosis), and/or psychological/behavioral (e.g., self-efficacy, social support, outcome expectations, depression) factors moderate the intervention components' effects on ACS guideline scores. VII. To explore change in ACS guideline score in relation to change in fasting insulin, glucose, homeostatic model assessment (HOMA-IR), and inflammatory markers (e.g., Interleukin 6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), Tumour Necrosis Factor alpha (TNF-alpha) from enrollment to 48 weeks among people with CRC. VIII. To explore change in ACS guideline score in relation to change in fatigue, depression, and sleep quality from 0 to 24 and 48 weeks among people with CRC. IX. To explore changes in the ACS guideline score in relation to change in the gut microbiome among people with CRC. OUTLINE: All patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with colon or rectal cancer. Patients are randomized to 1 of 16 conditions. CONDITION I: Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks. CONDITION II: Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks. CONDITION III: Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks. CONDITION IV: Patients receive text messages and use digital health tool kit for 48 weeks. CONDITION V: Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks. CONDITION VI: Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks. CONDITION VII: Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks. CONDITION VIII: Patients receive text messages for 48 weeks. CONDITION IX: Patients use digital health tool kit for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks. CONDITION X: Patients use digital health tool kit for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks. CONDITION XI: Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks. CONDITION XII: Patients use digital health tool kit for 48 weeks. CONDITION XIII: Patients receive 15 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks. CONDITION XIV: Patients receive 15 health coaching sessions over 30-45 minutes each for 48 weeks. CONDITION XV: Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks. CONDITION XVI: Patients receive personal report and booklet only.

Keywords

Stage I Colon Cancer AJCC v8 Stage I Rectal Cancer AJCC v8 Stage II Colon Cancer AJCC v8 Stage II Rectal Cancer AJCC v8 Stage IIA Colon Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8 Stage IIB Colon Cancer AJCC v8 Stage IIB Rectal Cancer AJCC v8 Stage IIC Colon Cancer AJCC v8 Stage IIC Rectal Cancer AJCC v8 Stage III Colon Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 Stage IIIA Colon Cancer AJCC v8 Stage IIIA Rectal Cancer AJCC v8 Stage IIIB Colon Cancer AJCC v8 Stage IIIB Rectal Cancer AJCC v8 Stage IIIC Colon Cancer AJCC v8 Stage IIIC Rectal Cancer AJCC v8 Rectal Neoplasms Colonic Neoplasms Educational Intervention Health Education Health Promotion and Education - Direct Text Messaging Health Promotion and Education - Digital health tool kit

Eligibility

You can join if…

Open to people ages 18 years and up

INCLUSION CRITERIA FOR CANCER SURVIVORS:

  • >= 18 years of age
  • Diagnosis of stage I-III colon or rectal cancer
  • Undergone curative-intent complete surgical resection
  • Completed all neoadjuvant and adjuvant cytotoxic chemotherapy or radiation (if indicated) prior to enrollment
  • Owns a smart phone that has access to the Internet and can receive daily text messages
  • Able to speak and read English or Spanish
  • Have a support person >= 18 years of age who speaks English or Spanish and is willing to provide informed consent and support the participant throughout the study
  • >= 4 weeks since a major surgery to start of intervention (removal of port or catheter (cath) is not major surgery; reversal of ostomy is major surgery and will require at least 4 weeks prior to enrollment)
  • Readiness, as determined by the Physical Activity Readiness Questionnaire (PAR-Q). If there are any indications that home-based exercise might be unsafe based on PAR-Q, the patient will not be enrolled until confirmation from the patient's provider is received via email and/or phone that they are safe to exercise. Providers do not need to be contacted if patients answer 'yes' to 'Is your doctor currently prescribing any medication for your blood pressure or for a heart condition?

INCLUSION CRITERIA FOR SUPPORT PERSONS:

  • Identified by a cancer survivor participant who has consented to participate in Tools To Be Fit as their support person
  • 18 years of age or older
  • Speaks and reads English or Spanish
  • Consents to complete two online surveys and four 1-on-1 health coaching calls during the 48 week study

You CAN'T join if...

EXCLUSION CRITERIA FOR CANCER SURVIVORS:

  • People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance
  • ACS guideline score of >= 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity. Our screening survey will ask participants to report their height and weight; usual intake of foods in the ACS guidelines (e.g., red and processed meat, fruits, vegetables, grains); and the Godin Leisure Time Exercise Survey
  • Used a physical activity tracker and a diet tracking app for >= 1 week in the past 3 months; these are components of our digital health tool kit
  • Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded)
  • Scheduled to receive any form of further cancer therapy during the study period
  • Concurrent, actively treated other cancer (except non-melanoma skin cancer, in situ cervical cancer or localized prostate cancer treated with surveillance only)
  • History of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility
  • History of psychiatric disorders that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent
  • Participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial
  • Currently pregnant or trying to become pregnant during the study period
  • Living outside the United States during screening and/or the 48-week study period

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Dana Farber Cancer Institute not yet accepting patients
    Boston Massachusetts 02215 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05056077
Study Type
Interventional
Last Updated