eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors

Malignant Solid Neoplasm Clinical Trial

— MiVSEEV  

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"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04081298
• Other study ID #: RG1005660
• Secondary ID: NCI-2019-05372P3
• Status: Terminated
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: June 2023
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 25, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Behavioral:
• Health Education
Attend nutrition and PA classes, and cooking sessions

Other:
• Physical Activity
Participate in physical activities
• Health Promotion and Education: Text Messages
Receive motivational text messages
• Health Promotion and Education: Web Site
Given access to nutrition website
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Retention	Number of participants that completed the follow-up (3 month) data collection. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3-months
Primary	Feasibility: Adherence for Text Messages	Number of participants who responded to 1 or more text messages. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Adherence of Grocery Deliveries	Number of times participant received all 6 grocery deliveries. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Adherence for Online Sessions	For the purpose of this feasibility study, participants who completed at least 3 of the 6 online sessions were assessed. Participants attend 6 online nutrition and 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 Health Education: Attend nutrition and PA classes, and cooking sessions Physical Activity: Participate in physical activities This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability of Cooking Sessions	Acceptability of the cooking sessions was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability of Recipes	Acceptability of recipes was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability Nutrition and Physical Activity Sessions	Acceptability of the nutrition and physical activity sessions was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability of Nutrition Text Messages	Acceptability of the nutrition text messages was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability of Physical Activity Text Messages	Acceptability of physical activity text messages was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability of Website	Acceptability of the website was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery.This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability of FITBit	Acceptability of the FITBit was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery.This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability of Monthly check-in Calls	Acceptability of monthly check-in calls was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Primary	Feasibility: Acceptability of Contact With Study Staff	Acceptability of contact with study staff was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.	At 3 months
Secondary	Nutrition Preferences: Fruit and Vegetables	Nutrition preferences were measured using 17-questions adapted from a battery developed and validated by the study team. The battery is titled "The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaires for Latinas" (preparing manuscript for submission). Participants were asked to rate their like or dislike for 11 specific fruits or vegetables (e.g., green cabbage, kale, turkey or veggie burgers, foods made with oil instead of butter or lard). For each fruit or vegetable listed they were asked to rate on a 5 point likert scale with 1=strongly dislike to 5=strongly like or respond with "never tried it"=0. Scores are averaged across the 17 items. Higher scores are considered a better outcome.	Baseline and 3 months
Secondary	Nutrition Self-Efficacy	Nutrition Self-efficacy was measured using 11-questions from a battery developed and validated by the study team. The battery is titled "The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaires for Latinas" (preparing manuscript for submission). Participants were asked to rate thow confident they are in their ability to engage in healthy dietary behaviors for one month. For each behavior listed they were asked to rate on a 5 point likert scale with 1=not at all confident to 5=extremely confident. Scores are averaged across the 11 items. Higher scores are considered a better outcome.	Baseline and 3 months
Secondary	Nutrition Knowledge	Nutrition knowledge was a single question. The value reflects a change in the percent of women who correctly answered the targeted number of daily serving intake of fruits and vegetables at baseline compared to 3-month follow-up. The correct answer was 5-9 servings per day.	Change in correct nutrition knowledge response from baseline to 3 month follow-up
Secondary	Physical Activity Preferences	Physical Activity preferences were measured using 8-questions from a battery developed and validated by the study team. The battery is titled "The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaires for Latinas" (preparing manuscript for submission). Participants were asked to rate their like or dislike for 8 specific types of physical activity (e.g., doing housework with vigorous effort, dancing in a group setting, playing with children with vigorous effort). For each activity listed they were asked to rate on a 5 point likert scale with 1=strongly dislike to 5=strongly like or respond with "never tried it"=0. Scores are averaged across the 8 items. Higher scores are considered a better outcome.	Baseline and 3 months
Secondary	Physical Activity Self-Efficacy	Physical Activity Self-Efficacy: Self-efficacy was measured using 5-questions from a battery developed and validated by the study team. The battery is titled "The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaires for Latinas" (preparing manuscript for submission). Participants were asked to rate how confident they are in their ability to engage in healthy physical activity behaviors given certain conditions (e.g., when you can't notice any improvements in your fitness, when you have many other demands on your time, when you feel a little stiff or sore) for one month. For each behavior listed they were asked to rate on a 5 point likert scale with 1=not at all confident to 5=extremely confident. Scores are averaged across the 5 items. Higher scores are considered a better outcome.	Baseline and 3 months
Secondary	Self-Reported Physical Activity: Time Sitting	Self-reported physical activity reflects change in time spent sitting (minutes/day). NOTE: The outcomes are reported as a change score (value at 3 months minus value at baseline)	Baseline and 3 month follow-up
Secondary	Self-Reported Physical Activity: Walking	Self-reported physical activity: walking (MET-minutes/week). NOTE: METs=metabolic equivalent of task. Walking in this case is defined as a light activity equivalent to < 3 METs. The outcomes are reported as a change score (value at 3 months minus value at baseline).	Baseline and 3 month-follow-up
Secondary	Self-Reported Physical Activity: Moderate to Vigorous Physical Activity	Self-reported physical activity includes moderate to vigorous physical activity (MET-minutes/week).; NOTE: METs=metabolic equivalent of task. Moderate to Vigorous Physical Activity is considered activities estimated at 3 or more METs. The outcomes are reported as a change score (value at 3 months minus value at baseline)	Baseline and 3-month follow-up