Improving Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit) (TTBF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05056077 |
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Recruitment Status :
Recruiting
First Posted : September 24, 2021
Last Update Posted : February 23, 2024
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Sponsor:
University of California, San Francisco
Collaborators:
National Cancer Institute (NCI)
University of California, Davis
Robert H. Lurie Cancer Center
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
University of California, San Francisco
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer Breast Cancer Colon Cancer Endometrial Cancer Ovarian Cancer Rectal Cancer Prostate Cancer Renal Cell Carcinoma Kidney Cancer | Other: Counseling Other: Educational Intervention Behavioral: Health Education Other: Health Promotion and Education - Direct Text Messaging Other: Health Promotion and Education - Digital health tool kit Other: Questionnaires | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit) |
| Actual Study Start Date : | October 21, 2021 |
| Estimated Primary Completion Date : | December 31, 2027 |
| Estimated Study Completion Date : | December 31, 2027 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Condition I (text, health kit, health coach, support coach)
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 a history of 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.
|
Other: Counseling
Receive support person coaching
Other Name: Counseling Intervention Other: Educational Intervention Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Behavioral: Health Education Receive health coaching
Other Name: Health Coaching Other: Health Promotion and Education - Direct Text Messaging Receive text messages
Other Name: Text Messaging Other: Health Promotion and Education - Digital health tool kit Receive digital health tool kit
Other Name: Educational, Digital health tool kit Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition II (text, health kit, health coach)
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 a history of cancer 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.
|
Other: Educational Intervention
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Behavioral: Health Education Receive health coaching
Other Name: Health Coaching Other: Health Promotion and Education - Direct Text Messaging Receive text messages
Other Name: Text Messaging Other: Health Promotion and Education - Digital health tool kit Receive digital health tool kit
Other Name: Educational, Digital health tool kit Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition III (text, health kit, support coach)
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 a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.
|
Other: Counseling
Receive support person coaching
Other Name: Counseling Intervention Other: Educational Intervention Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Other: Health Promotion and Education - Direct Text Messaging Receive text messages
Other Name: Text Messaging Other: Health Promotion and Education - Digital health tool kit Receive digital health tool kit
Other Name: Educational, Digital health tool kit Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition IV (text, health kit)
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 a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks.
|
Other: Educational Intervention
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Other: Health Promotion and Education - Direct Text Messaging Receive text messages
Other Name: Text Messaging Other: Health Promotion and Education - Digital health tool kit Receive digital health tool kit
Other Name: Educational, Digital health tool kit Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition IX (health kit, health coach, support coach)
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 a history of 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.
|
Other: Counseling
Receive support person coaching
Other Name: Counseling Intervention Other: Educational Intervention Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Behavioral: Health Education Receive health coaching
Other Name: Health Coaching Other: Health Promotion and Education - Digital health tool kit Receive digital health tool kit
Other Name: Educational, Digital health tool kit Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition V (text, health coach, support coach)
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 a history of 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.
|
Other: Counseling
Receive support person coaching
Other Name: Counseling Intervention Other: Educational Intervention Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Behavioral: Health Education Receive health coaching
Other Name: Health Coaching Other: Health Promotion and Education - Direct Text Messaging Receive text messages
Other Name: Text Messaging Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition VI (text, health coach)
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 a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.
|
Other: Educational Intervention
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Behavioral: Health Education Receive health coaching
Other Name: Health Coaching Other: Health Promotion and Education - Direct Text Messaging Receive text messages
Other Name: Text Messaging Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition VII (text, support coach)
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 a history of 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.
|
Other: Counseling
Receive support person coaching
Other Name: Counseling Intervention Other: Educational Intervention Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Other: Health Promotion and Education - Direct Text Messaging Receive text messages
Other Name: Text Messaging Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition VIII (text)
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 a history of cancer. Patients receive text messages for 48 weeks.
|
Other: Educational Intervention
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Other: Health Promotion and Education - Direct Text Messaging Receive text messages
Other Name: Text Messaging Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition X (health kit, health coach)
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 a history of 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.
|
Other: Educational Intervention
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Behavioral: Health Education Receive health coaching
Other Name: Health Coaching Other: Health Promotion and Education - Digital health tool kit Receive digital health tool kit
Other Name: Educational, Digital health tool kit Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition XI (health kit, support coach)
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 a history of 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.
|
Other: Counseling
Receive support person coaching
Other Name: Counseling Intervention Other: Educational Intervention Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Other: Health Promotion and Education - Digital health tool kit Receive digital health tool kit
Other Name: Educational, Digital health tool kit Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition XII (health kit)
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 a history of cancer. Patients use digital health tool kit for 48 weeks.
|
Other: Educational Intervention
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Other: Health Promotion and Education - Digital health tool kit Receive digital health tool kit
Other Name: Educational, Digital health tool kit Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition XIII (health coach, support coach)
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 a history of 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.
|
Other: Counseling
Receive support person coaching
Other Name: Counseling Intervention Other: Educational Intervention Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Behavioral: Health Education Receive health coaching
Other Name: Health Coaching Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition XIV (health coach)
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 a history of cancer. Patients receive 15 health coaching sessions over 30-45 minutes each for 48 weeks.
|
Other: Educational Intervention
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Behavioral: Health Education Receive health coaching
Other Name: Health Coaching Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: Condition XV (support coach)
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 a history of cancer. Support persons receive four coaching sessions lasting 30-45 minutes each, approximately every 12 weeks for 48 weeks.
|
Other: Counseling
Receive support person coaching
Other Name: Counseling Intervention Other: Educational Intervention Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
|
Experimental: 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 a history of cancer.
|
Other: Educational Intervention
Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer
Other Names:
Other: Questionnaires Quality of Life and Behavioral Questionnaires
Other Name: Quality of Life Questionnaires |
Primary Outcome Measures :
- Mean change in American Cancer Society (ACS) guideline score at 48 weeks [ Time Frame: Up to 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 [ Time Frame: Up to 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 [ Time Frame: Up to 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 [ Time Frame: Up to 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
INCLUSION CRITERIA FOR CANCER SURVIVORS:
- >= 18 years of age.
- Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer.
- Completed all neoadjuvant and adjuvant cytotoxic chemotherapy or radiation (if indicated) prior to enrollment. Hormonal treatments for breast and prostate cancer 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?
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 cancer therapy during the study period with the exception of hormonal treatments for breast and prostate cancer, 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.
EXCLUSION CRITERIA FOR SUPPORT PERSONS:
1. None.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056077
Contacts
| Contact: Paige Steiding | (415) 514-6314 | paige.steiding@ucsf.edu |
Locations
| United States, California | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Paige Steiding 415-514-6314 toolstobefit@ucsf.edu | |
| Contact 877-827-3222 cancertrials@ucsf.edu | |
| Principal Investigator: Erin Van Blarigan, ScD | |
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
University of California, Davis
Robert H. Lurie Cancer Center
Dana-Farber Cancer Institute
Investigators
| Principal Investigator: | Erin Van Blarigan, ScD | University of California, San Francisco |
Additional Information:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT05056077 |
| Other Study ID Numbers: |
21456 NCI-2021-09059 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) R37CA248774 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 24, 2021 Key Record Dates |
| Last Update Posted: | February 23, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Keywords provided by University of California, San Francisco:
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Cancer Survivors Nutrition |
Additional relevant MeSH terms:
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Carcinoma, Renal Cell Endometrial Neoplasms Kidney Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases Urogenital Diseases Male Urogenital Diseases Genital Diseases, Female Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Genital Neoplasms, Female Urologic Neoplasms Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Uterine Neoplasms Uterine Diseases |