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

ENROLLING
Protocol # :
21-554
Conditions
Bladder Cancer
Breast Cancer
Colon Cancer
Endometrial Cancer
Ovarian Cancer
Rectal Cancer
Prostate Cancer
Renal Cell Carcinoma
Kidney Cancer
Phase
Not Applicable
Disease Sites
Colon
Rectum
Principal Investigator
Meyerhardt, Jeffrey
Site Research Nurses
Houghton, Nicole
Miles, Brandy

Trial Description

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.

Eligibility Requirements

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 neoadjuvant and adjuvant cytotoxic chemotherapy or radiation (if
indicated) prior to enrollment. Hormonal treatments for breast and prostate cancer 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 for breast and prostate cancer, 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.

21-554