83 Participants Needed

Mobile App for Lifestyle Changes in Cancer Survivors

EC
CV
Overseen ByCarmina Valle
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have untreated hypertension, hyperlipidemia, or diabetes, you need permission from your healthcare provider to participate.

What data supports the idea that Mobile App for Lifestyle Changes in Cancer Survivors is an effective treatment?

The available research shows that mobile health (mHealth) interventions, like the Mobile App for Lifestyle Changes in Cancer Survivors, are promising for improving physical activity and diet among cancer survivors. A systematic review found that most participants were satisfied with the intervention, and many studies reported significant improvements in behavior and quality of life. This suggests that using a mobile app can be an effective way to help cancer survivors make positive lifestyle changes.12345

What safety data exists for the mobile app for lifestyle changes in cancer survivors?

The research provided does not directly address safety data for the specific mobile app for lifestyle changes in cancer survivors. However, it includes studies on similar interventions like nutrition apps and text message interventions, which have been evaluated for usability, feasibility, and acceptability. For example, the SAlBi educa app was found to be user-friendly and motivating, while a text message intervention for Hispanic cancer survivors showed high acceptability and feasibility. These studies suggest that such digital interventions are generally well-received and could be safe, but specific safety data for the app in question is not provided.26789

Is the treatment 'Mobile App for Lifestyle Changes in Cancer Survivors' a promising treatment?

Yes, the treatment using mobile apps for lifestyle changes in cancer survivors is promising. Research shows that these apps can help improve diet and physical activity, leading to better health and quality of life for cancer survivors. Many participants found the apps helpful and were satisfied with the support they provided.56101112

What is the purpose of this trial?

The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.

Research Team

EM

Erin M Coffman, MA

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for young adult cancer survivors aged 18-39 who were diagnosed with invasive cancer between ages 15-39, are not currently very active or eating enough fruits and vegetables, have finished their main cancer treatments except maintenance therapy, and have no progressive disease. They must be able to use the internet weekly, speak English, and commit to being randomly assigned to any study group.

Inclusion Criteria

I don't have health issues that would stop me from following an exercise program on my own.
Have access to the Internet on at least a weekly basis
I was diagnosed with cancer between 15 and 39 years old.
See 6 more

Exclusion Criteria

I cannot walk for exercise due to health issues.
I have been diagnosed or treated for an eating disorder in the past.
Currently exercising > 150 minutes/week of moderate-to-vigorous intensity physical activity
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 3-month digital physical activity and nutrition intervention, including evidence-based lessons and behavioral skills training

12 weeks
Baseline, 6 weeks, and 3 months assessments

Follow-up

Participants are monitored for changes in physical activity, diet quality, and secondary outcomes

4 weeks

Treatment Details

Interventions

  • Core
  • Lesson Delivery (Once)
  • Lesson Delivery (Weekly)
  • Nutrition Goals (No)
  • Nutrition Goals (Yes)
  • Simplified Nutrition Monitoring (Green)
  • Simplified Nutrition Monitoring (Red)
  • Supportive Text Messages (No)
  • Supportive Text Messages (Yes)
Trial Overview The trial tests a mobile intervention combining physical activity guidance and diet quality improvement for young adult cancer survivors. It includes various combinations of lesson delivery (weekly or once), nutrition monitoring (red or green levels), supportive text messages (yes or no), and setting nutrition goals (yes or no).
Participant Groups
16Treatment groups
Experimental Treatment
Group I: Condition 9Experimental Treatment5 Interventions
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
Group II: Condition 8Experimental Treatment5 Interventions
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Group III: Condition 7Experimental Treatment5 Interventions
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
Group IV: Condition 6Experimental Treatment5 Interventions
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
Group V: Condition 5Experimental Treatment5 Interventions
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Group VI: Condition 4Experimental Treatment5 Interventions
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Group VII: Condition 3Experimental Treatment5 Interventions
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
Group VIII: Condition 2Experimental Treatment5 Interventions
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Group IX: Condition 16Experimental Treatment5 Interventions
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Group X: Condition 15Experimental Treatment5 Interventions
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
Group XI: Condition 14Experimental Treatment5 Interventions
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
Group XII: Condition 13Experimental Treatment5 Interventions
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Group XIII: Condition 12Experimental Treatment5 Interventions
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Group XIV: Condition 11Experimental Treatment5 Interventions
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
Group XV: Condition 10Experimental Treatment5 Interventions
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Group XVI: Condition 1Experimental Treatment5 Interventions
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Nutrition plays a crucial role in the health of cancer patients and survivors, providing them with empowerment and support during their treatment journey, as highlighted by a qualitative study involving 12 oncology providers and 12 survivors.
The proposed 'NutriCare' program was well-received, particularly the idea of using a prescription pad for nutrition advice, but barriers such as time constraints and provider motivation need to be addressed for effective implementation.
Perceptions of Oncology Providers and Cancer Survivors on the Role of Nutrition in Cancer Care and Their Views on the "NutriCare" Program.Keaver, L., Yiannakou, I., Folta, SC., et al.[2021]
This report highlights the need for more research on optimal nutrition for cancer survivors, as most dietary guidelines focus on cancer prevention rather than post-treatment care.
It provides evidence-based dietary recommendations tailored to different phases of cancer survivorship and specific cancer types, along with a FAQ section to enhance communication between survivors and healthcare providers.
Nutrition during and after cancer treatment: a guide for informed choices by cancer survivors.Brown, J., Byers, T., Thompson, K., et al.[2019]
A review of five European guidelines for cancer survivors revealed that while they emphasize the importance of consuming fruits, vegetables, and whole grains, they lack detailed nutritional strategies tailored specifically for this population.
The highest quality guideline, the ESPEN guidelines, still fell short in providing practical implementation strategies for healthcare professionals, highlighting a significant gap in nutrition guidance for cancer survivors.
Evidence-based nutrition guidelines for cancer survivors in Europe: a call for action.Keaver, L., Houlihan, C., O'Callaghan, N., et al.[2022]

References

Perceptions of Oncology Providers and Cancer Survivors on the Role of Nutrition in Cancer Care and Their Views on the "NutriCare" Program. [2021]
Nutrition during and after cancer treatment: a guide for informed choices by cancer survivors. [2019]
Evidence-based nutrition guidelines for cancer survivors in Europe: a call for action. [2022]
Patient-Important Needs and Goals Related to Nutrition Interventions during Cancer Treatment. [2023]
mHealth Interventions to Promote a Healthy Diet and Physical Activity among Cancer Survivors: A Systematic Review of Randomized Controlled Trials. [2022]
Feasibility and Acceptability of a Text Message Intervention to Promote Adherence to Nutrition and Physical Activity Guidelines in a Predominantly Hispanic Sample of Cancer Survivors and Their Informal Caregivers: Results from a Pilot Intervention Trial. [2023]
Nutrition Literacy among Cancer Survivors: Feasibility Results from the Healthy Eating and Living Against Breast Cancer (HEAL-BCa) Study: a Pilot Randomized Controlled Trial. [2022]
Perceptions of self-monitoring dietary intake according to a plate-based approach: A qualitative study. [2023]
SAlBi educa (Tailored Nutrition App for Improving Dietary Habits): Initial Evaluation of Usability. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of mHealth diet interventions in cancer survivors: A systematic review and meta-analysis of randomized controlled trials. [2023]
A review of iPhone and Android apps for cancer patients and survivors: assessing their quality, nutrition information and behaviour change techniques. [2021]
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