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

NCT ID: NCT04081298

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2022-02-25

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Health services research (eHealth program)

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.

Group Type: EXPERIMENTAL

Health Education

Intervention Type: BEHAVIORAL

Attend nutrition and PA classes, and cooking sessions

Physical Activity

Intervention Type: OTHER

Participate in physical activities

Health Promotion and Education: Text Messages

Intervention Type: OTHER

Receive motivational text messages

Health Promotion and Education: Web Site

Intervention Type: OTHER

Given access to nutrition website

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Health Education

Attend nutrition and PA classes, and cooking sessions

Intervention Type: BEHAVIORAL

Physical Activity

Participate in physical activities

Intervention Type: OTHER

Health Promotion and Education: Text Messages

Receive motivational text messages

Intervention Type: OTHER

Health Promotion and Education: Web Site

Given access to nutrition website

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Text; Internet Website; Website; www-website; Quality of Life Assessment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Rachel Ceballos

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Ceballos

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2019-05372

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10270

Identifier Type: OTHER

Identifier Source: secondary_id

RG1005660

Identifier Type: -

Identifier Source: org_study_id