Mobile App for Lifestyle Changes in Cancer Survivors

Overseen By Carmina Valle

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must not be taking: Weight loss medications

Disqualifiers: Heart attack, Stroke, Psychiatric diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help young adult cancer survivors enhance their physical activity and nutrition. It examines various combinations of features, such as nutrition monitoring, supportive text messages, and lessons, to determine which is most effective. The trial seeks participants who have survived cancer, completed their treatment, and currently find it challenging to meet exercise and healthy eating guidelines. As an unphased trial, it provides a unique opportunity to contribute to innovative solutions for healthier living.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mobile apps can improve the quality of life for cancer survivors. One study found these apps promising for encouraging lifestyle changes, such as healthier eating and increased exercise, suggesting they are generally safe to use.

For simple nutrition tracking using green and red foods, direct safety data is limited. However, using a smartphone to track diet in this way aligns with recommendations from trusted sources like the American Cancer Society, which emphasize safe and beneficial healthy eating habits.

Text message support has also been widely studied. Research indicates these messages effectively provide health support, with high user satisfaction rates and a strong safety profile.

Overall, while direct safety data for each part of this app is limited, digital tools for health improvement are generally considered safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a mobile app can promote lifestyle changes specifically for cancer survivors. Unlike other treatments that might focus on medication or surgery, this approach uses digital tools to encourage healthier habits, like monitoring nutrition with color-coded feedback and providing educational lessons. The inclusion of supportive text messages adds a personalized touch, potentially keeping users motivated and engaged. By leveraging technology, this trial aims to discover if these digital interventions can effectively support long-term health improvements for cancer survivors, making it a promising area of study.

What evidence suggests that this trial's treatments could be effective for young adult cancer survivors?

Research has shown that using a mobile app can help cancer survivors feel more in control of their health. In this trial, participants will join different treatment arms featuring various combinations of app features. Some arms will use a simple system for tracking food intake—green for healthy foods like fruits and vegetables, and red for less healthy options like sweets. Studies have found that this can lead to better eating habits. Other arms will focus on setting goals to eat more plant-based foods, which is also linked to healthier eating. Additionally, some participants will receive supportive text messages to motivate healthier lifestyle choices. Together, these app features aim to help cancer survivors improve their diet and physical activity. ^{6 7 8 9 10}

Who Is on the Research Team?

Erin M Coffman, MA

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I cannot walk for exercise due to health issues.

I have been diagnosed or treated for an eating disorder in the past.

I have had a heart attack or stroke in the last 6 months.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

Group I: Condition 9 Experimental Treatment 5 Interventions

Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons

Group II: Condition 8 Experimental Treatment 5 Interventions

Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons

Group III: Condition 7 Experimental Treatment 5 Interventions

Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons

Group IV: Condition 6 Experimental Treatment 5 Interventions

Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons

Group V: Condition 5 Experimental Treatment 5 Interventions

Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons

Group VI: Condition 4 Experimental Treatment 5 Interventions

Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons

Group VII: Condition 3 Experimental Treatment 5 Interventions

Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons

Group VIII: Condition 2 Experimental Treatment 5 Interventions

Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons

Group IX: Condition 16 Experimental Treatment 5 Interventions

Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons

Group X: Condition 15 Experimental Treatment 5 Interventions

Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons

Group XI: Condition 14 Experimental Treatment 5 Interventions

Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons

Group XII: Condition 13 Experimental Treatment 5 Interventions

Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons

Group XIII: Condition 12 Experimental Treatment 5 Interventions

Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons

Group XIV: Condition 11 Experimental Treatment 5 Interventions

Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons

Group XV: Condition 10 Experimental Treatment 5 Interventions

Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons

Group XVI: Condition 1 Experimental Treatment 5 Interventions

Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons

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+

Published Research Related to This Trial

Mobile health (mHealth) diet interventions significantly improved dietary habits in cancer survivors, increasing fruit and vegetable intake and reducing fat intake, while also leading to weight loss and reductions in waist and hip circumference, based on a review of 15 randomized controlled trials involving 2363 participants.

These interventions also positively impacted the quality of life for cancer survivors, indicating that mHealth strategies could be an effective approach for dietary management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mHealth diet interventions in cancer survivors: A systematic review and meta-analysis of randomized controlled trials. Gong, Y., Jiang, X., Chen, X., et al.[2023]

A pilot study involving 19 participants, predominantly Hispanic cancer survivors and their caregivers, found that a two-week text message intervention based on American Cancer Society guidelines was feasible and acceptable, with over 80% recruitment and retention rates.

Participants reported a higher acceptability for physical activity messages (94%) compared to nutrition messages (86%), indicating that text messaging could effectively promote lifestyle changes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lopez-Pentecost, M., Perkin, S., Freylersythe, S., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition during and after cancer treatment: a guide for informed choices by cancer survivors. Brown, J., Byers, T., Thompson, K., et al.[2019]

A study involving interviews with 31 cancer patients and 17 clinicians identified key nutrition-related goals for patients, including weight maintenance, improved food satisfaction, and enhanced quality of life.

Both patients and clinicians emphasized the importance of patients having control over their food choices and receiving meals they enjoy, which will inform the development of a patient-centered assessment tool for nutrition interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Important Needs and Goals Related to Nutrition Interventions during Cancer Treatment. Foecke Munden, E., Kemp, M., Guth, A., et al.[2023]

The iCANPlateTM mobile application, designed to align with the 2019 Canada Food Guide, was positively received for its simplicity and ability to enhance self-awareness of dietary habits without focusing on calorie counting.

Participants expressed concerns about the app's effectiveness in promoting adherence to dietary self-monitoring due to issues like insufficient food classifications and challenges in understanding food proportions, indicating areas for improvement in future app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of self-monitoring dietary intake according to a plate-based approach: A qualitative study. Kheirmandparizi, M., Gouin, JP., Bouchaud, CC., et al.[2023]

A review of 12 cancer-related apps revealed low accountability (average score of 2.7 out of 8) and quality (average score of 2.9 out of 5), indicating that these apps may not provide reliable or high-quality information for users.

The apps primarily focused on healthy eating and energy needs but lacked specific strategies for implementation and did not adequately reference established guidelines from organizations like ESPEN and WCRF, suggesting a need for improvement in the nutritional content provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of iPhone and Android apps for cancer patients and survivors: assessing their quality, nutrition information and behaviour change techniques. Keaver, L., Loftus, A., Quinn, L.[2021]

A pilot study involving 41 hematologic malignancy survivors showed that a 16-week mHealth-supported intervention, which included individualized goal-setting and peer support via Facebook, was feasible and well-accepted, with a high participant retention rate of 90.2%.

While the intervention did not yield statistically significant differences in activity or dietary outcomes compared to the control group, it was associated with improvements in dietary factors and physical activity levels, indicating potential benefits for cardiovascular risk reduction in cancer survivors.

NCBI (Pubmed)

pubmed.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. Chow, EJ., Doody, DR., Di, C., et al.[2022]

A systematic review of 23 randomized controlled trials involving cancer survivors showed that mobile health (mHealth) interventions significantly improved physical activity and dietary habits, with 11 out of 18 studies reporting notable behavioral changes.

Participants expressed high satisfaction with the mHealth interventions, with a median satisfaction rate of 87%, indicating that these technology-based approaches are well-received and feasible for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Promote a Healthy Diet and Physical Activity among Cancer Survivors: A Systematic Review of Randomized Controlled Trials. Wang, L., Langlais, CS., Kenfield, SA., et al.[2022]

The SAlBi educa app, designed with input from healthcare and nutrition professionals, was evaluated for usability and found to be user-friendly, with 94% of participants finding it easy to learn and 59% describing it as pleasant.

In a 1-month pilot test with 39 participants, over 84% reported that the nutritional messages were clear and useful, highlighting the app's potential to effectively promote healthy eating habits based on the Mediterranean diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAlBi educa (Tailored Nutrition App for Improving Dietary Habits): Initial Evaluation of Usability. Gonzalez-Ramirez, M., Cejudo-Lopez, A., Lozano-Navarrete, M., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based nutrition guidelines for cancer survivors in Europe: a call for action. Keaver, L., Houlihan, C., O'Callaghan, N., et al.[2022]

A pilot study involving 59 breast cancer survivors showed that nutrition education workshops were well-received and feasible, with high follow-up rates of 89% in the control group and 77% in the intervention group.

While the workshops did not significantly improve nutrition literacy scores at the 3-month follow-up, participants valued the social support and expressed a desire for more tailored dietary information, indicating potential for future interventions to enhance dietary knowledge among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Literacy among Cancer Survivors: Feasibility Results from the Healthy Eating and Living Against Breast Cancer (HEAL-BCa) Study: a Pilot Randomized Controlled Trial. Parekh, N., Jiang, J., Buchan, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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