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Improving Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit) (TTBF)

Primary Purpose

Stage I Colon Cancer AJCC v8, Stage I Rectal Cancer AJCC v8, Stage II Colon Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Educational Intervention
Health Education
Health Promotion and Education - Direct Text Messaging
Health Promotion and Education - Digital health tool kit
Questionnaires
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage I Colon Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

INCLUSION CRITERIA FOR CANCER SURVIVORS:

  1. >= 18 years of age.
  2. Diagnosis of stage I-III colon or rectal cancer.
  3. Undergone curative-intent complete surgical resection.

    • Patients who have received non-operative management for rectal cancer are eligible so long as they are in survivorship with no evidence of cancer and no further treatment planned."
  4. Completed all neoadjuvant and adjuvant cytotoxic chemotherapy or radiation (if indicated) prior to enrollment.
  5. Owns a smart phone that has access to the Internet and can receive daily text messages.
  6. Able to speak and read English or Spanish
  7. 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.
  8. >= 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).
  9. 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:

  1. Identified by a cancer survivor participant who has consented to participate in Tools To Be Fit as their support person.
  2. 18 years of age or older.
  3. Speaks and reads English or Spanish.
  4. Consents to complete two online surveys and four 1-on-1 health coaching calls during the 48 week study.

Exclusion Criteria:

EXCLUSION CRITERIA FOR CANCER SURVIVORS:

  1. People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance.
  2. 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.
  3. 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.
  4. Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded)
  5. Scheduled to receive any form of further cancer therapy during the study period.
  6. Concurrent, actively treated other cancer (except non-melanoma skin cancer, in situ cervical cancer or localized prostate cancer treated with surveillance only).
  7. 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.
  8. 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.
  9. 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.
  10. Currently pregnant or trying to become pregnant during the study period.
  11. Living outside the United States during screening and/or the 48-week study period.

EXCLUSION CRITERIA FOR SUPPORT PERSONS:

1. None.

Sites / Locations

  • University of California San FranciscoRecruiting
  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Condition I (text, health kit, health coach, support coach)

Condition II (text, health kit, health coach)

Condition III (text, health kit, support coach)

Condition IV (text, health kit)

Condition IX (health kit, health coach, support coach)

Condition V (text, health coach, support coach)

Condition VI (text, health coach)

Condition VII (text, support coach)

Condition VIII (text)

Condition X (health kit, health coach)

Condition XI (health kit, support coach)

Condition XII (health kit)

Condition XIII (health coach, support coach)

Condition XIV (health coach)

Condition XV (support coach)

Condition XVI (study booklet)

Arm Description

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 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.

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 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.

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 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.

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 receive text messages and use digital health tool kit for 48 weeks.

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 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.

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 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.

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 receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.

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 receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.

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 receive text messages for 48 weeks.

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 use digital health tool kit for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.

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 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.

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 use digital health tool kit for 48 weeks.

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 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.

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 receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.

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. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.

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.

Outcomes

Primary Outcome Measures

Mean change in American Cancer Society (ACS) guideline score at 48 weeks
The ACS Guideline Score is comprised of scores on participant reported food intake (score range from 0-2), physical activity (score range from 0-2), and body mass index (BMI) (score range from 0-2). The total score is calculated by summing the scores on each component with a total score range from 0 to 6. Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in ACS score as repeated measures and using a generalized linear mixed effect model, starting with the saturated model, including coefficients for main effects, interactions up to 3-way, and stratification variables (gender and age), and reduce the model via backward variable selection with a 0.05 significance level (alpha(α)=0.05) up to 48 weeks.

Secondary Outcome Measures

Mean change in ACS guideline score at 24 weeks
The ACS Guideline Score is comprised of scores on participant reported food intake (score range from 0-2), physical activity (score range from 0-2), and body mass index (BMI) (score range from 0-2). The total score is calculated by summing the scores on each component with a total score range from 0 to 6. Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in ACS score as repeated measures and using a generalized linear mixed effect model, starting with the saturated model, including coefficients for main effects, interactions up to 3-way, and stratification variables (gender and age), and reduce the model via backward variable selection with a 0.05 significance level (α=0.05) up to 24 weeks.
Mean change in scores on the individual components of the ACS at 24 weeks
The ACS Guideline Score is comprised of individual factor scores on (1) participant reported food intake (score range from 0-2), (2) physical activity (score range from 0-2), and (3) body mass index (BMI) (score range from 0-2). Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in the individual ACS guideline factors from 0 to 24 weeks using linear mixed-effects models adjusting for the stratification variables gender and age with the individual factor of interest as the outcome.
Mean change in scores on the individual components of the ACS at 48 weeks
The ACS Guideline Score is comprised of individual factor scores on (1) participant reported food intake (score range from 0-2), (2) physical activity (score range from 0-2), and (3) body mass index (BMI) (score range from 0-2). Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in the individual ACS guideline factors from 0 to 48 weeks using linear mixed-effects models adjusting for the stratification variables gender and age with the individual factor of interest as the outcome.

Full Information

First Posted
September 14, 2021
Last Updated
October 11, 2023
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05056077
Brief Title
Improving Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit)
Acronym
TTBF
Official Title
Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Condition I (text, health kit, health coach, support coach)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Condition II (text, health kit, health coach)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Condition III (text, health kit, support coach)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Condition IV (text, health kit)
Arm Type
Experimental
Arm Description
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 receive text messages and use digital health tool kit for 48 weeks.
Arm Title
Condition IX (health kit, health coach, support coach)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Condition V (text, health coach, support coach)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Condition VI (text, health coach)
Arm Type
Experimental
Arm Description
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 receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.
Arm Title
Condition VII (text, support coach)
Arm Type
Experimental
Arm Description
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 receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.
Arm Title
Condition VIII (text)
Arm Type
Experimental
Arm Description
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 receive text messages for 48 weeks.
Arm Title
Condition X (health kit, health coach)
Arm Type
Experimental
Arm Description
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 use digital health tool kit for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.
Arm Title
Condition XI (health kit, support coach)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Condition XII (health kit)
Arm Type
Experimental
Arm Description
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 use digital health tool kit for 48 weeks.
Arm Title
Condition XIII (health coach, support coach)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Condition XIV (health coach)
Arm Type
Experimental
Arm Description
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 receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.
Arm Title
Condition XV (support coach)
Arm Type
Experimental
Arm Description
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. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.
Arm Title
Condition XVI (study booklet)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Receive support person coaching
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive personal report and booklet on nutrition and physical activity for patients with colon or rectal cancer
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Other Intervention Name(s)
Health Coaching
Intervention Description
Receive health coaching
Intervention Type
Other
Intervention Name(s)
Health Promotion and Education - Direct Text Messaging
Other Intervention Name(s)
Text Messaging
Intervention Description
Receive text messages
Intervention Type
Other
Intervention Name(s)
Health Promotion and Education - Digital health tool kit
Other Intervention Name(s)
Educational, Digital health tool kit
Intervention Description
Receive digital health tool kit
Intervention Type
Other
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Quality of Life Questionnaires
Intervention Description
Quality of Life and Behavioral Questionnaires
Primary Outcome Measure Information:
Title
Mean change in American Cancer Society (ACS) guideline score at 48 weeks
Description
The ACS Guideline Score is comprised of scores on participant reported food intake (score range from 0-2), physical activity (score range from 0-2), and body mass index (BMI) (score range from 0-2). The total score is calculated by summing the scores on each component with a total score range from 0 to 6. Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in ACS score as repeated measures and using a generalized linear mixed effect model, starting with the saturated model, including coefficients for main effects, interactions up to 3-way, and stratification variables (gender and age), and reduce the model via backward variable selection with a 0.05 significance level (alpha(α)=0.05) up to 48 weeks.
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Mean change in ACS guideline score at 24 weeks
Description
The ACS Guideline Score is comprised of scores on participant reported food intake (score range from 0-2), physical activity (score range from 0-2), and body mass index (BMI) (score range from 0-2). The total score is calculated by summing the scores on each component with a total score range from 0 to 6. Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in ACS score as repeated measures and using a generalized linear mixed effect model, starting with the saturated model, including coefficients for main effects, interactions up to 3-way, and stratification variables (gender and age), and reduce the model via backward variable selection with a 0.05 significance level (α=0.05) up to 24 weeks.
Time Frame
Up to 24 weeks
Title
Mean change in scores on the individual components of the ACS at 24 weeks
Description
The ACS Guideline Score is comprised of individual factor scores on (1) participant reported food intake (score range from 0-2), (2) physical activity (score range from 0-2), and (3) body mass index (BMI) (score range from 0-2). Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in the individual ACS guideline factors from 0 to 24 weeks using linear mixed-effects models adjusting for the stratification variables gender and age with the individual factor of interest as the outcome.
Time Frame
Up to 24 weeks
Title
Mean change in scores on the individual components of the ACS at 48 weeks
Description
The ACS Guideline Score is comprised of individual factor scores on (1) participant reported food intake (score range from 0-2), (2) physical activity (score range from 0-2), and (3) body mass index (BMI) (score range from 0-2). Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in the individual ACS guideline factors from 0 to 48 weeks using linear mixed-effects models adjusting for the stratification variables gender and age with the individual factor of interest as the outcome.
Time Frame
Up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: INCLUSION CRITERIA FOR CANCER SURVIVORS: >= 18 years of age. Diagnosis of colon or rectal cancer. Undergone curative-intent complete surgical resection. Patients who have received non-operative management for rectal cancer are eligible so long as they are in survivorship with no evidence of cancer and no further treatment planned." 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. Exclusion Criteria: 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. EXCLUSION CRITERIA FOR SUPPORT PERSONS: 1. None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paige Steiding
Phone
(415) 514-6314
Email
paige.steiding@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Van Blarigan, ScD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paige Steiding
Phone
415-514-6314
Email
paige.steiding@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Erin Van Blarigan, ScD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit)

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