Improving Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit) (TTBF)
Stage I Colon Cancer AJCC v8, Stage I Rectal Cancer AJCC v8, Stage II Colon Cancer AJCC v8
About this trial
This is an interventional supportive care trial for Stage I Colon Cancer AJCC v8
Eligibility Criteria
Inclusion Criteria:
INCLUSION CRITERIA FOR CANCER SURVIVORS:
- >= 18 years of age.
- Diagnosis of stage I-III 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.
Sites / Locations
- University of California San FranciscoRecruiting
- Dana Farber Cancer Institute
Arms of the Study
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Experimental
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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)
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.