Mobile App for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Metastatic cancer, Palliative treatment, Diabetes, Hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The overarching purpose of this study is to assess whether patients will use the app throughout treatment on a regular basis, as the ultimate goal is to provide an educational platform that can impact patient behaviors and understanding towards health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since patients undergoing systemic therapy are eligible, it seems likely that you can continue your current treatments.

What data supports the effectiveness of the treatment RestoreMe in the Mobile App for Cancer trial?

Research shows that mobile apps can help detect cancer symptoms early and improve treatment adherence, which can lead to better survival rates. For example, a smartphone app helped detect lung cancer relapses early and improved adherence to breast cancer treatments, suggesting that similar apps could support the effectiveness of RestoreMe. ^{1 2 3 4 5}

Is the mobile app for cancer treatment safe for humans?

The mobile app has been used to help monitor symptoms and side effects in cancer patients, aiming to improve safety by allowing early detection and treatment of adverse events. It has been tested in clinical settings, showing potential to enhance patient safety and treatment outcomes by improving the reporting and management of side effects. ^{6 7 8 9 10}

How is the treatment RestoreMe different from other cancer treatments?

RestoreMe is unique because it involves a mobile app designed to support cancer treatment, which is not a common approach for cancer therapies. This app-based treatment may offer benefits like remote monitoring and management of symptoms, making it more convenient and accessible for patients compared to traditional treatments. ^{11 12 13 14 15}

Research Team

Rafi Kabarriti, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for cancer patients who have a smartphone, can read/write in English, and are undergoing or planning to undergo curative radiation therapy. They must be able to use mobile apps and have an ECOG performance status of 0-2. It's not for those with fluid/nutrient restrictions, metastatic cancer, palliative treatment, uncontrolled hypertension, or poorly controlled diabetes.

Inclusion Criteria

Patients must have a smartphone or other device with the ability to receive text messages, download and use mobile applications

I have received any type of radiation therapy aimed at curing my cancer.

Ability to read and write in English

Exclusion Criteria

Any medical condition requiring fluid restriction or nutrient restrictions

My cancer has spread to other parts of my body.

I am receiving treatment to ease symptoms, not cure my disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Treatment

Participants use the RestoreMe app during their active cancer treatment to assess regularity and effectiveness of app usage

Up to 12 months

Follow-up/Survivorship Care

Participants in post-radiation therapy follow-up/survivorship care use the RestoreMe app to continue monitoring and engagement

Up to 12 months

Follow-up

Participants are monitored for app engagement and satisfaction after treatment

4 weeks

Treatment Details

Interventions

• RestoreMe

Trial Overview The study is testing the RestoreMe app's effectiveness as an educational tool for cancer patients to assist with diet, nutrition, and activity during their treatment. The goal is to see if it changes patient behaviors and improves understanding of health.

Participant Groups

Group I: Follow-up/Survivorship Care Experimental Treatment 1 Intervention

25 patients who are in post-radiation therapy follow-up/survivorship care after completing definitive treatment.

Group II: Active Treatment Experimental Treatment 1 Intervention

25 patients who prior to initiation of curative treatment.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Findings from Research

The self-assessment smartphone app alerted 72.6% of users about concerning symptoms related to tobacco-induced diseases, with current smokers showing a higher incidence of symptoms like fatigue and cough, indicating a significant awareness of health issues.

During the study, the incidence of early-stage lung cancer (stages 1 and 2) increased to 24% among users, compared to 9% in the previous year, suggesting that the app may enhance early detection of lung cancer and encourage smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. Stavaux, E., Goupil, F., Barreau, G., et al.[2023]

A study involving 4475 breast cancer patients showed that using a smartphone app significantly improved adherence to multidisciplinary treatment (MDT) recommendations, with a notable reduction in noncompliance rates from 27.4% in 2013 to 8.8% in 2019.

Patients who used the app were 39% less likely to deviate from MDT recommendations compared to those who did not use the app, particularly improving compliance with adjuvant chemotherapy and radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone-Based App to Improve Adjuvant Treatment Adherence to Multidisciplinary Decisions in Patients With Early-Stage Breast Cancer: Observational Study. Yu, J., Wu, J., Huang, O., et al.[2021]

The SeamlessMD App significantly improved patient engagement and satisfaction during the perioperative period for 50 patients undergoing robotic lung cancer surgery, with over 74% finding it very or extremely useful.

Patients using the App reported a significant decrease in maximum pain levels and anxiety scores post-surgery, and 40.9% indicated that the health-checks helped them avoid unnecessary calls or hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient engagement, adherence, and satisfaction in lung cancer surgery with implementation of a mobile device platform for patient reported outcomes. Kneuertz, PJ., Jagadesh, N., Perkins, A., et al.[2022]

The Outcomes4Me mobile app was successfully integrated into routine breast cancer care, with 60% of the 107 patients engaging with it at least three times over a 12-week period, surpassing the feasibility target of 40%.

Patients reported that the app improved their ability to track symptoms and increased their interest in clinical trial enrollment, indicating potential benefits for patient education and decision-making in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of introducing a smartphone navigation application into the care of breast cancer patients (The FIONA Study). Isakoff, SJ., Said, MR., Kwak, AH., et al.[2023]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

A survey of 727 stakeholders in cancer clinical research revealed that 93% believe patient-reported outcomes (PROs) for adverse events would enhance understanding of patient experiences during treatment.

The majority of respondents (88%) felt that using the PRO-CTCAE would improve the quality and efficiency of symptom data collection, indicating strong support for its implementation in clinical trials to inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Bruner, DW., Hanisch, LJ., Reeve, BB., et al.[2022]

In a study of 3,046 postmenopausal women with ductal carcinoma in situ, 28.5% discontinued treatment with anastrozole or tamoxifen, with specific adverse events like thrombosis and arthralgia linked to discontinuation of both drugs.

Patient-reported outcomes (PROs) such as pain interference and hot flashes were significant factors in discontinuing tamoxifen, while only hot flashes were associated with discontinuation of anastrozole, highlighting the importance of both adverse events and patient experiences in treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity Index, Patient-Reported Outcomes, and Early Discontinuation of Endocrine Therapy for Breast Cancer Risk Reduction in NRG Oncology/NSABP B-35. Henry, NL., Kim, S., Hays, RD., et al.[2023]

A systematic review of 54 articles over the last 10 years found that mobile apps for cancer management are increasingly being researched, particularly for early detection, with a focus on melanoma.

Despite the growth in studies, many of the apps developed for cancer management tend to be removed from app stores after the research is completed, making it difficult for users to access them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications in oncology: A systematic review of health science databases. Ana, FA., Loreto, MS., José, LM., et al.[2020]

Out of 776 health apps identified for supporting breast cancer treatment and aftercare, only 12 were classified as partially recommended and just 3 as recommended, indicating that most apps do not meet quality standards for patient support.

The evaluation criteria included user assessments and scientific benefits, highlighting that while some apps may offer potential benefits for breast cancer patients, the majority lack sufficient quality and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review. Gomm, SIM., Ebner, FK., Lukac, S., et al.[2023]

Mobile applications can effectively help manage chemotherapy-related side effects in early breast cancer patients, as shown in four out of six apps reviewed, leading to improved quality of life and reduced symptom burden.

While these apps show promise in enhancing symptom monitoring during treatment, further research is necessary to confirm their effectiveness and safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications for early breast cancer chemotherapy-related symptoms reporting and management: A scoping review. Suchodolska, G., Senkus, E.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

A Smartphone-Based App to Improve Adjuvant Treatment Adherence to Multidisciplinary Decisions in Patients With Early-Stage Breast Cancer: Observational Study. [2021]

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

Digital therapeutic to improve cancer-related well-being: a pilot randomized controlled trial. [2023]

4. China pubmed.ncbi.nlm.nih.gov

Improving patient engagement, adherence, and satisfaction in lung cancer surgery with implementation of a mobile device platform for patient reported outcomes. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of introducing a smartphone navigation application into the care of breast cancer patients (The FIONA Study). [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. [2022]

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

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2022]

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

Toxicity Index, Patient-Reported Outcomes, and Early Discontinuation of Endocrine Therapy for Breast Cancer Risk Reduction in NRG Oncology/NSABP B-35. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Under-reporting of harm in clinical trials. [2022]

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Mobile applications in radiation oncology-current choices and future potentials. [2023]

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

Apps for Radiation Oncology. A Comprehensive Review. [2020]

13. Ireland pubmed.ncbi.nlm.nih.gov

Mobile applications in oncology: A systematic review of health science databases. [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review. [2023]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile applications for early breast cancer chemotherapy-related symptoms reporting and management: A scoping review. [2022]