Clinical trial NCT04081298: eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors
Official title: Adaptation and Evaluation of an Online and eHealth Diet and Physical Activity Program to Improve Cardiometabolic Health in Rural Latino Adults "Mi Vida Saludable en el Valle"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Keywords: Cancer Survivor
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial studies how to improve the diet quality and physical activity level of Latino cancer survivors living in rural areas. The recommendation to eat a high-quality diet and engage in moderate-to-vigorous physical exercise may reduce cancer risk, improve cancer survival rate, and reduce associated conditions. However, it is not well understood how best to teach cancer survivors, especially Latino cancer survivors living in rural areas, to achieve and maintain diet and physical activity. Understanding how to build a culturally appropriate education that is effective may improve the diet quality and physical activity level of Latino cancer survivors.

Detailed description: OUTLINE:

Patients attend 6 online nutrition and physical activity (PA) education classes, cooking sessions, and participate in physical activities over 120 minutes each. Patients also receive text messages, electronic newsletters and have access to an interactive nutrition website.

After completion of study, patients are followed up periodically.

Eligibility criteria: Inclusion Criteria:

* Participants must self-identify as being at least 18 years of age or older
* Participants must self-identify as Latino
* Participants must be a resident of the Lower Yakima Valley (LYV) and anticipate remaining in the LYV for at least 1 year
* Participants must speak Spanish or English and fully understand Spanish for online group sessions
* Participants must self-identify as having a medical history of hypertension
* Participants must self-identify as having a medical history of diabetes
* Participants must self-identify as having a medical history of cardiovascular disease
* Participants must self-identify as having a medical history of obesity, as defined by a body mass index (BMI) of \> 30 kg/m\^2
* Participants must self-identify as having a medical history of cancer (excluding non-melanoma skin cancer). All other cancer types will be included provided
* There is no evidence of recurrent or metastatic disease
* The patient has not received a bone marrow, stem cell, or cord blood transplant
* For cancer survivors, participants must self-identify as being at least 60 days post final chemotherapy, biologic therapy, or radiation therapy treatment and/or surgery. Current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors)
* Participants must be willing and able to receive text messages via cellphone for 3-6 months
* Participants must be willing and able to attend six 120-minute online group sessions
* Participants must be willing to complete the surveys, and diet/PA assessments
* Participants who report having been told by a health professional they have diabetes or cardiovascular disease must provide a clearance from their physician for participation
* Participants must consume \< 5 servings of fruits and vegetables per day and/or engage in \< 150 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires
* Participants must have an Eastern Cooperative Oncology Group (ECOG) scale of performance status score of 0 or 1 for performance status. These scales and criteria are commonly used by doctors and trained research staff to assess a person's daily living abilities. These scales and criteria are commonly used by doctors and trained research staff to assess a person's daily living abilities. Scores of 0 and 1 corresponds to being fully active, able to carry on all pre-disease performance without restriction; and restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, respectively
* Ability to understand and the willingness to sign an online informed consent document \* Depending on preference, the consent will be provided in English or Spanish

Exclusion Criteria:

* Participants must not be active smokers within the past 30 days. Active smoking is defined as any smoking, even a puff. Participants who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for participants to stop smoking than it is to change their dietary patterns. If identified as a smoker, the individual will be referred the Centers for Disease Control and Prevention (CDC) "Quit Now" phone line which supports smoking cessation, or the National Institutes of Health (NIH) quit support website SmokeFree.gov which are both available in English and Spanish
* Women must not be pregnant at time of enrollment

Primary outcomes:
measure: Feasibility: Retention
timeFrame: At 3-months
measure: Feasibility: Adherence for Text Messages
timeFrame: At 3 months
measure: Feasibility: Adherence of Grocery Deliveries
timeFrame: At 3 months
measure: Feasibility: Adherence for Online Sessions
timeFrame: At 3 months
measure: Feasibility: Acceptability of Cooking Sessions
timeFrame: At 3 months
measure: Feasibility: Acceptability of Recipes
timeFrame: At 3 months
measure: Feasibility: Acceptability Nutrition and Physical Activity Sessions
timeFrame: At 3 months
measure: Feasibility: Acceptability of Nutrition Text Messages
timeFrame: At 3 months
measure: Feasibility: Acceptability of Physical Activity Text Messages
timeFrame: At 3 months
measure: Feasibility: Acceptability of Website
timeFrame: At 3 months
measure: Feasibility: Acceptability of FITBit
timeFrame: At 3 months
measure: Feasibility: Acceptability of Monthly check-in Calls
timeFrame: At 3 months
measure: Feasibility: Acceptability of Contact With Study Staff
timeFrame: At 3 months
Secondary outcomes:
measure: Nutrition Preferences: Fruit and Vegetables
timeFrame: Baseline and 3 months
measure: Nutrition Self-Efficacy
timeFrame: Baseline and 3 months
measure: Nutrition Knowledge
timeFrame: Change in correct nutrition knowledge response from baseline to 3 month follow-up
measure: Physical Activity Preferences
timeFrame: Baseline and 3 months
measure: Physical Activity Self-Efficacy
timeFrame: Baseline and 3 months
measure: Self-Reported Physical Activity: Time Sitting
timeFrame: Baseline and 3 month follow-up
measure: Self-Reported Physical Activity: Walking
timeFrame: Baseline and 3 month-follow-up
measure: Self-Reported Physical Activity: Moderate to Vigorous Physical Activity
timeFrame: Baseline and 3-month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Rachel Ceballos
role: PRINCIPAL_INVESTIGATOR
References: