Clinical trial NCT05056077: Improving Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
Official title: Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Breast Cancer
Colon Cancer
Endometrial Cancer
Ovarian Cancer
Rectal Cancer
Prostate Cancer
Renal Cell Carcinoma
Kidney Cancer
Keywords: Cancer Survivors
Nutrition
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of California, Davis
name: Robert H. Lurie Cancer Center
name: Dana-Farber Cancer Institute
First posted: 2021-09-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on change cancer survivors' American Cancer Society (ACS) guideline score after 48 weeks of intervention.

SECONDARY OBJECTIVES:

I. To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on cancer survivors' American Cancer Society (ACS) guideline score after 24 weeks of intervention.

II. To determine the effect of four candidate intervention components, and combinations of the four intervention components, on cancer survivors' intake of fruits and vegetables, whole grains, refined grains, red meat, and processed meats; moderate-to-vigorous physical activity; and body mass index (BMI) after 48 weeks of intervention.

EXPLORATORY OBJECTIVES:

I. To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person coaching), and combinations of the four intervention components, on cancer survivors' American Cancer Society (ACS) guideline score after 12 weeks of intervention.

II. To describe adherence to each intervention component.

III. To explore the effects of each of the candidate intervention components (text messaging, digital health tool kit, health coaching, support person training) on theoretical constructs (e.g., self-efficacy, outcome expectations, self-monitoring, social support) from 0 to 24 and 48 weeks.

IV. To explore whether sociodemographic (e.g., gender, age, race/ethnicity), clinical (e.g., stage of disease, treatment history, ostomy status, time since diagnosis), and/or psychological/behavioral (e.g., self-efficacy, social support, outcome expectations, depression) factors moderate the intervention components' effects on ACS guideline scores.

VII. To explore change in ACS guideline score in relation to change in fasting insulin, glucose, homeostatic model assessment (HOMA-IR), and inflammatory markers (e.g., Interleukin 6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), Tumor Necrosis Factor alpha (TNF-alpha) for a subset of participants from enrollment to 48 weeks among people with a history of cancer.

VIII. To explore change in ACS guideline score in relation to change in fatigue, depression, and sleep quality from 0 to 24 and 48 weeks among people with a history of cancer.

IX. To explore changes in the ACS guideline score in relation to change in the gut microbiome among a subset of participants with a history of cancer.

OUTLINE: All 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 are randomized to 1 of 16 conditions.

CONDITION I: 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. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

CONDITION II: Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 each for 48 weeks.

CONDITION III: 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: Patients receive text messages and use digital health tool kit for 48 weeks.

CONDITION V: Patients receive text messages 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 VI: Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.

CONDITION VII: 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: Patients receive text messages for 48 weeks.

CONDITION IX: 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 X: 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: 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: Patients use digital health tool kit for 48 weeks.

CONDITION XIII: 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: Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks.

CONDITION XV: Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.

CONDITION XVI: Patients receive personal report and booklet only.

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.

Primary outcomes:
measure: Mean change in American Cancer Society (ACS) guideline score at 48 weeks
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Mean change in ACS guideline score at 24 weeks
timeFrame: Up to 24 weeks
measure: Mean change in scores on the individual components of the ACS at 24 weeks
timeFrame: Up to 24 weeks
measure: Mean change in scores on the individual components of the ACS at 48 weeks
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Erin Van Blarigan, ScD
role: PRINCIPAL_INVESTIGATOR
References: