Trials / Recruiting
RecruitingNCT05056077
Improving Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. X. To describe cancer survivors' 10-year cardiovascular risk using the American Heart Association (AHA) Predicting Risk of cardiovascular disease (CVD) EVENTS (PREVENT) score. 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.
Conditions
- Bladder Cancer
- Breast Cancer
- Colon Cancer
- Endometrial Cancer
- Ovarian Cancer
- Rectal Cancer
- Prostate Cancer
- Renal Cell Carcinoma
- Kidney Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Counseling | Receive support person coaching |
| OTHER | Educational Intervention | Receive personal report and booklet on nutrition and physical activity for patients with a history of cancer |
| BEHAVIORAL | Health Education | Receive health coaching |
| OTHER | Health Promotion and Education - Direct Text Messaging | Receive text messages |
| OTHER | Health Promotion and Education - Digital health tool kit | Receive digital health tool kit |
| OTHER | Questionnaires | Quality of Life and Behavioral Questionnaires |
Timeline
- Start date
- 2021-10-21
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
- First posted
- 2021-09-24
- Last updated
- 2025-07-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05056077. Inclusion in this directory is not an endorsement.