Improving Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
TTBF
Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
3 other identifiers
interventional
1,000
1 country
1
Brief Summary
This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in cancer survivors. Studies indicate that people with a history of 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 a history of cancer adopt recommended health behaviors after they have completed treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedStudy Start
First participant enrolled
October 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
July 22, 2025
July 1, 2025
6.2 years
September 14, 2021
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 48 weeks
Secondary Outcomes (3)
Mean change in ACS guideline score at 24 weeks
Up to 24 weeks
Mean change in scores on the individual components of the ACS at 24 weeks
Up to 24 weeks
Mean change in scores on the individual components of the ACS at 48 weeks
Up to 48 weeks
Study Arms (16)
Condition I (text, health kit, health coach, support coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
Condition II (text, health kit, health coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
Condition III (text, health kit, support coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
Condition IV (text, health kit)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks.
Condition IX (health kit, health coach, support coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
Condition V (text, health coach, support coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
Condition VI (text, health coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
Condition VII (text, support coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
Condition VIII (text)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks.
Condition X (health kit, health coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
Condition XI (health kit, support coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
Condition XII (health kit)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks.
Condition XIII (health coach, support coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
Condition XIV (health coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks.
Condition XV (support coach)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
Condition XVI (study booklet)
EXPERIMENTALPatients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer.
Interventions
Receive support person coaching
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Receive health coaching
Receive text messages
Receive digital health tool kit
Quality of Life and Behavioral Questionnaires
Eligibility Criteria
You may qualify if:
- \>= 18 years of age.
- Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer.
- Completed all cytotoxic chemotherapy, immunotherapy, targeted therapies, or radiation (if indicated) prior to enrollment. Hormonal treatments are allowed.
- 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?
- Identified by a cancer survivor participant who has consented to participate in Tools To Be Fit as their support person.
- 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 may not qualify if:
- 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 cancer therapy during the study period with the exception of hormonal treatments, which are allowed.
- 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.
- \. None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- National Cancer Institute (NCI)collaborator
- University of California, Daviscollaborator
- Robert H. Lurie Cancer Centercollaborator
- Dana-Farber Cancer Institutecollaborator
- American Heart Associationcollaborator
Study Sites (1)
University of California San Francisco
San Francisco, California, 94143, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Van Blarigan, ScD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2021
First Posted
September 24, 2021
Study Start
October 21, 2021
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
July 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
De-identified data will be shared with research collaborators during the course of the study.