Hematopoietic and Lymphoid Cell NeoplasmMiVSEEVNCT04081298
eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors
A study testing Health Education, Physical Activity and Health Promotion and Education: Text Messages in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Health Education, Physical Activity and Health Promotion and Education: Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 25 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
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"
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.
Read the 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.
- Being tested
- Health Education, Physical Activity, Health Promotion and Education: Text Messages, Health Promotion and Education: Web Site, Quality-of-Life Assessment
- Keywords
- Cancer Survivor
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
Attend nutrition and PA classes, and cooking sessions
Physical ActivityOther
Participate in physical activities
Health Promotion and Education: Text MessagesOther
Also called Text
Receive motivational text messages
Health Promotion and Education: Web SiteOther
Also called Internet Website, Website, www-website
Given access to nutrition website
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 3 months
Secondary outcomes (8)
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Change in correct nutrition knowledge response from baseline to 3 month follow-up
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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)
Measured: Baseline and 3 month follow-up
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).
Measured: Baseline and 3 month-follow-up
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)
Measured: Baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start16 Sep 2021
- Primary completion11 Feb 2022
- Study completion25 Feb 2022
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rachel Ceballos, Fred Hutchinson Cancer Center
- Investigators
- Rachel Ceballos, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081298
- Sponsor's protocol ID
- RG1005660
- Other IDs
- NCI-2019-05372, P30CA015704, 10270
- Acronym
- MiVSEEV
- Status last verified
- Jun 2023
- First submitted
- 5 Sep 2019
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04081298
- Acronym / sponsor ID
- MiVSEEV / RG1005660
- Keywords
- Cancer Survivor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (eHealth program) | Experimental | 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 AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationAttend nutrition and PA classes, and cooking sessions | Behavioural | Health services research (eHealth program) |
| Physical ActivityParticipate in physical activities | Other | Health services research (eHealth program) |
| Health Promotion and Education: Text MessagesAlso: TextReceive motivational text messages | Other | Health services research (eHealth program) |
| Health Promotion and Education: Web SiteAlso: Internet Website, Website, www-websiteGiven access to nutrition website | Other | Health services research (eHealth program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Health services research (eHealth program) |
| Questionnaire AdministrationAncillary studies | Other | Health services research (eHealth program) |
Primary outcome
Feasibility: Retention
Time frame: At 3-months
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.
Feasibility: Adherence for Text Messages
Time frame: At 3 months
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.
Feasibility: Adherence of Grocery Deliveries
Time frame: At 3 months
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.
Feasibility: Adherence for Online Sessions
Time frame: At 3 months
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.
Feasibility: Acceptability of Cooking Sessions
Time frame: At 3 months
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.
Feasibility: Acceptability of Recipes
Time frame: At 3 months
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.
Feasibility: Acceptability Nutrition and Physical Activity Sessions
Time frame: At 3 months
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.
Feasibility: Acceptability of Nutrition Text Messages
Time frame: At 3 months
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.
Feasibility: Acceptability of Physical Activity Text Messages
Time frame: At 3 months
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.
Feasibility: Acceptability of Website
Time frame: At 3 months
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.
Feasibility: Acceptability of FITBit
Time frame: At 3 months
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.
Feasibility: Acceptability of Monthly check-in Calls
Time frame: At 3 months
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.
Feasibility: Acceptability of Contact With Study Staff
Time frame: At 3 months
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.
8 secondary outcomes
Nutrition Preferences: Fruit and Vegetables
Time frame: Baseline and 3 months
Nutrition Self-Efficacy
Time frame: Baseline and 3 months
Nutrition Knowledge
Time frame: Change in correct nutrition knowledge response from baseline to 3 month follow-up
Physical Activity Preferences
Time frame: Baseline and 3 months
Physical Activity Self-Efficacy
Time frame: Baseline and 3 months
Self-Reported Physical Activity: Time Sitting
Time frame: Baseline and 3 month follow-up
Self-Reported Physical Activity: Walking
Time frame: Baseline and 3 month-follow-up
Self-Reported Physical Activity: Moderate to Vigorous Physical Activity
Time frame: Baseline and 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Ceballos principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education, Physical Activity and Health Promotion and Education: Text Messages in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Retention (time frame: At 3-months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023; AzTrials last refreshed its copy on 2 Nov 2026.