Improving nutrition and physical activity for cancer survivors

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

This study is testing whether different support methods can help cancer survivors eat better and be more active after their treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05056077 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the impact of four different intervention components—text messaging, a digital health toolkit, health coaching, and support person training—on the nutrition and physical activity of cancer survivors. The study aims to help participants adopt healthier habits consistent with the American Cancer Society's guidelines after completing cancer treatment. Participants will be assessed on their adherence to these interventions and changes in their health behaviors over a 48-week period.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have completed treatment for specific types of cancer and have access to a smartphone for communication.

Not a fit: Patients who are currently undergoing treatment or those who cannot engage with the required technology may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the health and disease-free survival of cancer survivors by promoting better nutrition and physical activity.

How similar studies have performed: Other studies have shown positive outcomes with similar interventions aimed at improving health behaviors in cancer survivors.

Eligibility criteria

Inclusion Criteria:

INCLUSION CRITERIA FOR CANCER SURVIVORS:

1. \>= 18 years of age.
2. Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer.
3. Completed all cytotoxic chemotherapy, immunotherapy, targeted therapies, or radiation (if indicated) prior to enrollment. Hormonal treatments are allowed.
4. Owns a smart phone that has access to the Internet and can receive daily text messages.
5. Able to speak and read English or Spanish
6. 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.
7. \>= 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).
8. 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 cancer therapy during the study period with the exception of hormonal treatments, which are allowed.
6. 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.
7. 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.
8. 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.
9. Currently pregnant or trying to become pregnant during the study period.
10. Living outside the United States during screening and/or the 48-week study period.

EXCLUSION CRITERIA FOR SUPPORT PERSONS:

1\. None.

Where this trial is running

San Francisco, California

• University of California San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Erin Van Blarigan, ScD — University of California, San Francisco
• Study coordinator: Evelyn Montenegro

Conditions Bladder Cancer; Breast Cancer; Colon Cancer; Endometrial Cancer; Ovarian Cancer; Rectal Cancer; Prostate Cancer; Renal Cell Carcinoma