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

NCT04081298 | Terminated Results

• 4 other identifiers: RG1005660NCI-2019-05372P30CA01570410270
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Keywords

Cancer Survivor

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Nutrition Preferences: Fruit and Vegetables

  Baseline and 3 months

• Nutrition Self-Efficacy

  Baseline and 3 months

• Nutrition Knowledge

  Change in correct nutrition knowledge response from baseline to 3 month follow-up

• Physical Activity Preferences

  Baseline and 3 months

• Physical Activity Self-Efficacy

  Baseline and 3 months

Study Arms (1)

Health services research (eHealth program)

EXPERIMENTAL

Patients 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.

Behavioral: Health Education; Other: Physical Activity; Other: Health Promotion and Education: Text Messages; Other: Health Promotion and Education: Web Site; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Health Education BEHAVIORAL

Attend nutrition and PA classes, and cooking sessions

Health services research (eHealth program)

Physical Activity OTHER

Participate in physical activities

Health services research (eHealth program)

Health Promotion and Education: Text Messages OTHER

Receive motivational text messages

Also known as: Text

Health services research (eHealth program)

Health Promotion and Education: Web Site OTHER

Given access to nutrition website

Also known as: Internet Website, Website, www-website

Health services research (eHealth program)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Health services research (eHealth program)

Questionnaire Administration OTHER

Ancillary studies

Health services research (eHealth program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Exercise; Health Promotion; Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Self-Help Devices; Equipment and Supplies

Results Point of Contact

• Title: Heather Greenlee
• Organization: Fred Hutchinson Cancer Center

hgreenlee@fredhutch.org

206-667-4502

Study Officials

• Rachel Ceballos

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: September 16, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 25, 2022
• Last Updated: July 3, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)