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

83 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{5 6 10 11 12}

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

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.

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

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

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+

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.

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]

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 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 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]

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]

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]

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]

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]

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 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]

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 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]

References

1. Switzerland 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Nutrition during and after cancer treatment: a guide for informed choices by cancer survivors. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Evidence-based nutrition guidelines for cancer survivors in Europe: a call for action. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patient-Important Needs and Goals Related to Nutrition Interventions during Cancer Treatment. [2023]

5. Switzerland 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. [2022]

6. Switzerland 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. [2023]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Perceptions of self-monitoring dietary intake according to a plate-based approach: A qualitative study. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

SAlBi educa (Tailored Nutrition App for Improving Dietary Habits): Initial Evaluation of Usability. [2023]

10. United States 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of mHealth diet interventions in cancer survivors: A systematic review and meta-analysis of randomized controlled trials. [2023]

12. England 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. [2021]