mHealth App for Prostate Cancer Survivors

Recruiting at 2 trial locations

Overseen By Sabrina Dickey, PhD, RN

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Other races, No CaP diagnosis, No smartphone, others

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

Compensation: Varies

Number of Visits: Unknown

248 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile health app designed to help Black men with prostate cancer manage their health and improve their quality of life. The study aims to assess the app's usability and gather feedback for improvement. Participants are divided into two groups: one uses the app, while the other does not. Ideal candidates are Black men diagnosed with prostate cancer within the last five years who own a smartphone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future health management tools.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mHealth app is safe for prostate cancer survivors?

Research has shown that mobile health (mHealth) apps are generally safe and easy to use. In studies of similar apps for issues like gambling addiction, users found them helpful and safe, with no major problems reported. This suggests that using an mHealth app for prostate cancer survivors is likely safe as well. Although specific safety data for this exact app is not available, mHealth technology for prostate cancer has been studied before without any safety concerns. This trial focuses on ensuring the app is user-friendly and meets patients' needs, rather than testing for safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The mHealth app is unique because it offers a personalized, digital approach to supporting prostate cancer survivors, particularly focusing on Black men who are either undergoing treatment or have completed it. Unlike traditional treatments that might focus solely on medication or surgery, this app provides tailored health management and support directly through a smartphone, making it accessible and convenient. Researchers are excited about this trial because it explores how digital health tools can enhance the quality of life and health outcomes for prostate cancer survivors by offering continuous support and monitoring beyond the hospital setting.

What evidence suggests that this mHealth app is effective for prostate cancer survivors?

Research has shown that mobile health (mHealth) apps can help manage health conditions by providing timely support and information. In this trial, participants in the intervention group will access an mHealth app designed for Black men with prostate cancer. Studies have found that such apps improve quality of life by offering culturally appropriate support and helping manage treatment side effects, enhancing overall well-being. Although direct evidence on this specific app is limited, the success of similar mHealth apps suggests potential benefits. Early findings indicate that these apps can be helpful for prostate cancer survivors. ^{1 2 3 4 5}

Who Is on the Research Team?

Motolani Adedipe, PhD, DPh, MS

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for Black individuals who are either currently undergoing treatment for prostate cancer or have survived it. The study aims to include those who can provide feedback on a mobile health app designed specifically for them.

Inclusion Criteria

I am a Black man, within 5 years of my prostate cancer diagnosis, and I was born in the US, Caribbean, or Africa.

Exclusion Criteria

I am a man and I do not own a smartphone.

I am a man not of Caucasian descent.

I have never been diagnosed with prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the mHealth app at home, completing daily symptom surveys and weekly mood assessments

12 months

Online surveys at 0, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for quality of life improvements using the FACT-P survey

12 months

What Are the Treatments Tested in This Trial?

Interventions

• mHealth App

Trial Overview The focus of the trial is on a mobile health (mHealth) app tailored for Black prostate cancer patients and survivors. Participants will use the app and complete surveys to assess its impact on their quality of life.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 2 Interventions

Participants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors, who are given access to the mHealth app for this study.

Group II: Control group Experimental Treatment 1 Intervention

Participants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

A study evaluated 457 mobile health applications (MHAs) for prostate cancer antigen (PSA) dosage, finding that only 24 met the criteria for quality assessment, with an overall mean score below the acceptable threshold.

The quality of these apps was generally low, but well-developed MHAs could enhance PSA screening efforts and improve access to care, especially for patients in rural areas, potentially leading to earlier detection and treatment of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile health application for prostate cancer antigen dosage: is it time to say goodbye to classic screening methods? Di Bello, F., di Mauro, E., Fusco, GM., et al.[2023]

The app-based intervention 'Mila Blooms' was developed to promote healthy eating and physical activity among adolescent survivors of childhood cancer, and it showed high participant retention (93.8%) over an 8-week period, indicating strong feasibility.

While the initial evaluation did not show significant behavior change, participants reported positive experiences with the app, highlighting its ease of use and enjoyment, and there were no adverse side effects, suggesting it is a safe and appealing option for health promotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mila Blooms: A Mobile Phone Application and Behavioral Intervention for Promoting Physical Activity and a Healthy Diet Among Adolescent Survivors of Childhood Cancer. Fuemmeler, BF., Holzwarth, E., Sheng, Y., et al.[2021]

The CHAT intervention, a 4-week mobile health program for African American breast cancer survivors, demonstrated high participant engagement and acceptability, with 85% of participants reporting positive behavior changes.

Participants in the intervention group significantly reduced their sedentary time by 4.37 hours per day and decreased fast food intake by 1.5 servings, indicating the potential effectiveness of mobile technology in improving health behaviors among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot and Feasibility Mobile Health Intervention to Support Healthy Behaviors in African American Breast Cancer Survivors. Allicock, M., Kendzor, D., Sedory, A., et al.[2022]

The Fit2Thrive app, designed to promote moderate and vigorous physical activity among breast cancer survivors, showed improved usability and quality scores after iterative testing with two groups of survivors, indicating it is user-friendly and acceptable for this population.

Participants provided positive feedback on various app features, such as self-monitoring and motivational notifications, suggesting that the app has potential to effectively encourage physical activity among breast cancer survivors, although further testing is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centered development of a smartphone application (Fit2Thrive) to promote physical activity in breast cancer survivors. Welch, WA., Solk, P., Auster-Gussman, L., et al.[2022]

The eHealth and mHealth markets are rapidly growing, with a projected value of $26 billion, but their application in Urology remains limited, with only 176 relevant apps identified out of 300,000 medical apps.

Successful examples like the Rotterdam Prostate Cancer Risk Calculator and Follow MyPSA app demonstrate the potential of eHealth tools to enhance clinical practice, highlighting the need for professional involvement in their development to ensure user safety and data privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eHealth and mHealth in prostate cancer detection and active surveillance. Pereira-Azevedo, NM., Venderbos, LDF.[2020]

A study of 68 mobile health apps for cancer survivorship found that iOS apps generally incorporated more health behavior change theories and personalization features than Android apps, with 67% of iOS apps including these elements compared to only 38% of Android apps.

The research highlights the importance of integrating human-computer interface design and health behavior theories into mobile health apps to enhance their effectiveness in delivering personalized health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apps seeking theories: results of a study on the use of health behavior change theories in cancer survivorship mobile apps. Vollmer Dahlke, D., Fair, K., Hong, YA., et al.[2018]

In a 2-week trial involving 32 adult radiation oncology patients, the Health Storylines app demonstrated favorable usability, with 81% of participants finding it easy to use.

The app was accessed a total of 711 times, indicating a high level of engagement among users, which suggests that mobile health tracking apps may be well-received in clinical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Usability and Acceptability of a Patient-Centered Mobile Health Tracking App Among a Sample of Adult Radiation Oncology Patients. Birkhoff, SD., Cantrell, MA., Moriarty, H., et al.[2019]

A comprehensive mobile health app for breast cancer self-management was developed over 18 months, featuring 11 functionalities that include personalized health information, exercise, and diet management.

The app uses algorithms to tailor content based on individual user information, such as treatment type and changes in therapy, enhancing personalized rehabilitation throughout the breast cancer care continuum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modular Mobile Health App for Personalized Rehabilitation Throughout the Breast Cancer Care Continuum: Development Study. Lim, JY., Kim, JK., Kim, Y., et al.[2021]

A 10-week pilot study with 10 breast cancer survivors showed that using the MapMyFitness app and a Facebook-based health education intervention significantly increased physical activity levels, with participants averaging an additional 2.6 minutes of moderate-to-vigorous activity and 1,657 more steps per day.

Participants also experienced notable health improvements, including a decrease in weight by 2.4 kg and body fat percentage by 2.3%, along with enhanced social support and quality of life, indicating that technology-based interventions can be effective for promoting health in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of smartphone application and social media intervention on breast cancer survivors' health outcomes. Pope, Z., Lee, JE., Zeng, N., et al.[2019]

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 systematic review of 29 studies found that mHealth apps significantly improve care management for breast cancer patients, showing positive effects on weight loss, quality of life, and stress reduction.

However, there is limited and inconclusive evidence regarding the effectiveness of mHealth apps in breast cancer prevention and early detection, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research-Tested Mobile Apps for Breast Cancer Care: Systematic Review. Jongerius, C., Russo, S., Mazzocco, K., et al.[2020]

mHealth applications have shown promise in improving pain and fatigue outcomes for cancer survivors, with three out of four studies reporting positive results for pain and four studies indicating improvements in fatigue.

While there is some evidence for benefits in psychological distress and sleep outcomes, the results were mixed, highlighting the need for further development and targeted approaches in mHealth interventions for cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mHealth for self-management in improving pain, psychological distress, fatigue, and sleep in cancer survivors: a systematic review. Hernandez Silva, E., Lawler, S., Langbecker, D.[2020]

Citations

1. icrg.org icrg.org/funded-research/large-grant-dont-go-there-a-geospatial-mhealth-app-for-gambling-disorder/

Large Grant: “Don't Go There: A Geospatial mHealth App ... Aim: Develop and test efficacy of a novel mHealth app that will capitalize on smartphones' global positioning software that recognizes a user's ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04158037/dont-go-there-a-geospatial-mhealth-app-for-gambling-disorder

A Geospatial mHealth App for Gambling Disorder The goal of this project is to develop and to test the efficacy of a novel mHealth app for gambling disorder. The app capitalizes on ...

3. withpower.com withpower.com/trial/phase-gambling-8-2021-615ab

mHealth App for Gambling Addiction Research shows that mobile health apps can be effective in delivering cognitive behavioral therapy (CBT) for gambling problems, as they provide real-time ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36627464/

Mobile health (mHealth) interventions in prostate cancer ... This scoping review explores the application of mHealth technology in prostate cancer (CaP) management along the survivorship continuum.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06651359

Using a mHealth App to Improve Quality-of-Life Outcomes ... The purpose of this study is to test the effectiveness of a culturally appropriate and specific mobile app for ethnically diverse Black men with prostate cancer ...