Mobile ApplicationsNCT06860425
Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity
A study testing RestoreMe in people with Mobile Applications and Cancer Patients, run by Montefiore Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobile Applications, Cancer Patients
- What is being tested?
- RestoreMe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of invasive malignancy of the brain, head and neck region, lung, breast (DCIS and invasive disease allowed), prostate, gastrointestinal system or gynecological region
- Planned to receive, or have received, radiation therapy treatment with curative intent
- Note: Patients undergoing systemic therapy are eligible
- Note: Any dose/fractionation of curative-intent radiation therapy is eligible
- Patients must have a smartphone or other device with the ability to receive text messages, download and use mobile applications
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Ability to read and write in English
- Provide written informed consent to participate in the study o NOTE: Patients enrolled on another clinical trial are eligible
Who cannot join
- Metastatic cancer
- Undergoing treatment with palliative intent
- Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL despite attempts to improve glucose control by fasting duration and adjustment of medications)
- Uncontrolled hypertension
- Any medical condition requiring fluid restriction or nutrient restrictions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
Rafi Kabarriti, MD, 914-629-7743, rkabarri@montefiore.org
About this study
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.
Read the detailed description
In the last decade, smartphones have become an essential part of society with the mobile application market offering services across all aspects of life, including healthcare. Mobile health care apps have developed a field of their own termed "mobile health" or m-health with apps available to help patients do everything from managing symptoms and tracking medications to improving treatment compliance.
Apps have been developed specifically tailored for oncology patients. One randomized controlled trial provided oncology patients receiving palliative care with a mobile application that used artificial intelligence (AI) to regularly monitor and manage pain between clinic visits. Results showed that the app was an effective tool to manage pain. Patients who used the app reported an overall decrease in pain severity and experienced fewer inpatient hospitalizations due to cancer-related pain compared with patients who did not use the app. M-health applications are well utilized in low-income populations and among both English and Spanish speakers.
Despite the exciting potential m-Health offers for providers and patients, it also presents challenges. One systematic review identified barriers to adoption of m-health apps by health care professionals including difficult user experience (i.e., users found the app difficult to use and navigate), design and technical issues, security concerns, and perceived usefulness. Therefore, when designing an m-Health app, care must be taken to ensure that it is functional, easy to use, and provides patients and providers with valuable information in order to ensure that users will engage with the app. M-health apps should also be designed to supplement information exchanged during clinical encounters, fill in gaps in clinical workflow, and be appropriate for the target patient population.
Low socioeconomic status is associated with increased disease prevalence and low quality of life after diagnosis. Bronx county, New York, which is coterminous with the New York City borough of The Bronx, is an urban, medically underserved and economically depressed area, which is associated with an elevated relative rate of chronic diseases including obesity, diabetes, hypertension and cardiovascular disease. Over 70% of patients served by the Montefiore-Einstein Cancer Center (MECC) live beneath the poverty line suggesting that the patient population served by MECC is at risk for poor nutrition status.
With the goal of improving availability of evidence-based nutritional information to MECC patients, both in the active-treatment and survivorship settings, the study team has developed "RestoreMe," an easy-to-use mobile device application that provides nutrition education, personalized recommendations, recipes, exercises and more. RestoreMe also allows cancer patients and providers an easy-to-use resource with which to communicate directly with one another, which may increase patient engagement and compliance with their overall care.
In this study, the study team will investigate the regularity of app use by patients and which functions of the app are used effectively and most often. Usage trends specific to particular patient subgroups will also be evaluated. The results of this feasibility study will inform a future prospective interventional study using the RestoreMe app.
- Conditions
- Mobile Applications, Cancer Patients
- Being tested
- RestoreMe
- Keywords
- Diet, Nutrition, Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestoreMeOther
Comprehensive mobile device application
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Other | 25 patients who prior to initiation of curative treatment. Receives: Other: RestoreMe |
| Follow-up/Survivorship Care | Other | 25 patients who are in post-radiation therapy follow-up/survivorship care after completing definitive treatment. Receives: Other: RestoreMe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction with the RestoreMe app will be measured using the Technology Acceptability Survey (TAS). The TAS consists of 10 questions including 7 quantitative items which will be used to assess Patient Satisfaction for the purposes of the study. Each of the 7 quantitative items on the survey represent a unique satisfaction parameter and are scored on a 5-point ordinal scale ranging from 1-5. Lower scores for an item correlate with increased satisfaction with the specific parameter and higher scores for an item correlate with decreased satisfaction for the specific parameter, yielding an overall possible scoring range of 7-35. Group scores will be summarized using basic descriptive statistics.
Measured: Upon completion of treatment regimen or up to 12 months (+/1 month) after study entry
Secondary outcomes (10)
Frequency of Dailly Engagement - Patients
Frequency of patient engagement will be assessed by the number/percentage of patients who interact with the RestoreMe app on a daily basis (i.e., number/percentage per day) as well as the number/percentage of days with at least one RestoreMe app engagement on a per patient basis (i.e., number/percentage of days with at least one patient engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Measured: Up to approximately 12 months (+/1 month) after study entry
Frequency of Weekly Engagement - Patients
Frequency of patient engagement will be assessed by the number/percentage of patients who interact with the RestoreMe app on a weekly basis (i.e., number/percentage per week) as well as the number/percentage of weeks with at least one RestoreMe app engagement on a per patient basis (i.e., number/percentage of weeks with at least one patient engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Measured: Up to approximately 12 months (+/1 month) after study entry
Frequency of Monthly Engagement - Patients
Frequency of patient engagement will be assessed by the number/percentage of patients who interact with the RestoreMe app on a monthly basis (i.e., number/percentage per month) as well as the number/percentage of months with at least one RestoreMe app engagement on a per patient basis (i.e., number/percentage of months with at least one patient engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Measured: Up to approximately 12 months (+/1 month) after study entry
Frequency of Daily Engagement - Providers
Frequency of provider engagement will be assessed by the number/percentage of providers who interact with the RestoreMe app on a daily basis (i.e., number/percentage per day) as well as the number/percentage of days with at least one RestoreMe app engagement on a per provider basis (i.e., number/percentage of days with at least one provider engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Measured: Up to approximately 12 months (+/1 month) after study entry
Frequency of Weekly Engagement - Providers
Frequency of provider engagement will be assessed by the number/percentage of providers who interact with the RestoreMe app on a weekly basis (i.e., number/percentage per week) as well as the number/percentage of weeks with at least one RestoreMe app engagement on a per provider basis (i.e., number/percentage of weeks with at least one provider engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Measured: Up to approximately 12 months (+/1 month) after study entry
Frequency of Monthly Engagement - Providers
Frequency of provider engagement will be assessed by the number/percentage of providers who interact with the RestoreMe app on a monthly basis (i.e., number/percentage per month) as well as the number/percentage of months with at least one RestoreMe app engagement on a per provider basis (i.e., number/percentage of months with at least one provider engagement). Results will be summarized and reported by study arm/group using basic descriptive statistics.
Measured: Up to approximately 12 months (+/1 month) after study entry
Average Daily Interaction Time - Patients
Average patient interaction time with the RestoreMe app will be measured on a daily basis to evaluate interaction over time. Group mean daily interaction time will be summarized and reported by study arm/group.
Measured: Up to approximately 12 months (+/1 month) after study entry
Average Weekly Interaction Time - Patients
Average patient interaction time with the RestoreMe app will be measured on a weekly basis to evaluate interaction over time. Group mean weekly interaction time will be summarized and reported by study arm/group.
Measured: Up to approximately 12 months (+/1 month) after study entry
Average Monthly Interaction Time - Patients
Average patient interaction time with the RestoreMe app will be measured on a monthly basis to evaluate interaction over time. Group mean monthly interaction time will be summarized and reported by study group.
Measured: Up to approximately 12 months (+/1 month) after study entry
Drop-out over time.
The proportion/percentage of patients who drop out of regular interaction with the RestoreMe app will be summarized and reported.
Measured: Up to approximately 12 months (+/1 month) after study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start28 Feb 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Mobile ApplicationsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafi Kabarriti, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860425
- Sponsor's protocol ID
- 2022-13979
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gagnon MP, Ngangue P, Payne-Gagnon J, Desmartis M. m-Health adoption by healthcare professionals: a systematic review. J Am Med Inform Assoc. 2016 Jan;23(1):212-20. doi: 10.1093/jamia/ocv052. Epub 2015 Jun 15.
PubMed 26078410Kamdar, Mihir M., et al.
Liu, Patrick, et al.
Mielck A, Vogelmann M, Leidl R. Health-related quality of life and socioeconomic status: inequalities among adults with a chronic disease. Health Qual Life Outcomes. 2014 Apr 25;12:58. doi: 10.1186/1477-7525-12-58.
PubMed 24761773NYS DOH. 2013-2014 NYS Expanded Behavioral Risk Factor Surveillance System, data as of 2015. Available: https://www.health.ny.gov/statistics/chac/general/g75.htm. Accessed 23 September 2016.
Pierce JP, Faerber S, Wright FA, Rock CL, Newman V, Flatt SW, Kealey S, Jones VE, Caan BJ, Gold EB, Haan M, Hollenbach KA, Jones L, Marshall JR, Ritenbaugh C, Stefanick ML, Thomson C, Wasserman L, Natarajan L, Thomas RG, Gilpin EA; Women's Healthy Eating and Living (WHEL) study group. A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: the Women's Healthy Eating and Living (WHEL) Study. Control Clin Trials. 2002 Dec;23(6):728-56. doi: 10.1016/s0197-2456(02)00241-6.
PubMed 12505249Chan DSM, Vieira AR, Aune D, Bandera EV, Greenwood DC, McTiernan A, Navarro Rosenblatt D, Thune I, Vieira R, Norat T. Body mass index and survival in women with breast cancer-systematic literature review and meta-analysis of 82 follow-up studies. Ann Oncol. 2014 Oct;25(10):1901-1914. doi: 10.1093/annonc/mdu042. Epub 2014 Apr 27.
PubMed 24769692Protani M, Coory M, Martin JH. Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis. Breast Cancer Res Treat. 2010 Oct;123(3):627-35. doi: 10.1007/s10549-010-0990-0. Epub 2010 Jun 23.
PubMed 20571870Ewertz M, Jensen MB, Gunnarsdottir KA, Hojris I, Jakobsen EH, Nielsen D, Stenbygaard LE, Tange UB, Cold S. Effect of obesity on prognosis after early-stage breast cancer. J Clin Oncol. 2011 Jan 1;29(1):25-31. doi: 10.1200/JCO.2010.29.7614. Epub 2010 Nov 29.
PubMed 21115856Chlebowski RT, Aiello E, McTiernan A. Weight loss in breast cancer patient management. J Clin Oncol. 2002 Feb 15;20(4):1128-43. doi: 10.1200/JCO.2002.20.4.1128.
PubMed 11844838Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.
PubMed 12711737Glade MJ. Food, nutrition, and the prevention of cancer: a global perspective. American Institute for Cancer Research/World Cancer Research Fund, American Institute for Cancer Research, 1997. Nutrition. 1999 Jun;15(6):523-6. doi: 10.1016/s0899-9007(99)00021-0. No abstract available.
PubMed 10378216Knoops KT, de Groot LC, Kromhout D, Perrin AE, Moreiras-Varela O, Menotti A, van Staveren WA. Mediterranean diet, lifestyle factors, and 10-year mortality in elderly European men and women: the HALE project. JAMA. 2004 Sep 22;292(12):1433-9. doi: 10.1001/jama.292.12.1433.
PubMed 15383513Morote J, Celma A, Planas J, Placer J, de Torres I, Olivan M, Carles J, Reventos J, Doll A. Role of serum cholesterol and statin use in the risk of prostate cancer detection and tumor aggressiveness. Int J Mol Sci. 2014 Aug 6;15(8):13615-23. doi: 10.3390/ijms150813615.
PubMed 25101846Kok DE, van Roermund JG, Aben KK, den Heijer M, Swinkels DW, Kampman E, Kiemeney LA. Blood lipid levels and prostate cancer risk; a cohort study. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):340-5. doi: 10.1038/pcan.2011.30. Epub 2011 Jul 5.
PubMed 21727905
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity
- ClinicalTrials.gov ID
- NCT06860425
- Acronym / sponsor ID
- 2022-13979
- Conditions
- Mobile Applications, Cancer Patients
- Keywords
- Diet, Nutrition, Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the last decade, smartphones have become an essential part of society with the mobile application market offering services across all aspects of life, including healthcare. Mobile health care apps have developed a field of their own termed "mobile health" or m-health with apps available to help patients do everything from managing symptoms and tracking medications to improving treatment compliance.
Apps have been developed specifically tailored for oncology patients. One randomized controlled trial provided oncology patients receiving palliative care with a mobile application that used artificial intelligence (AI) to regularly monitor and manage pain between clinic visits. Results showed that the app was an effective tool to manage pain. Patients who used the app reported an overall decrease in pain severity and experienced fewer inpatient hospitalizations due to cancer-related pain compared with patients who did not use the app. M-health applications are well utilized in low-income populations and among both English and Spanish speakers.
Despite the exciting potential m-Health offers for providers and patients, it also presents challenges. One systematic review identified barriers to adoption of m-health apps by health care professionals including difficult user experience (i.e., users found the app difficult to use and navigate), design and technical issues, security concerns, and perceived usefulness. Therefore, when designing an m-Health app, care must be taken to ensure that it is functional, easy to use, and provides patients and providers with valuable information in order to ensure that users will engage with the app. M-health apps should also be designed to supplement information exchanged during clinical encounters, fill in gaps in clinical workflow, and be appropriate for the target patient population.
Low socioeconomic status is associated with increased disease prevalence and low quality of life after diagnosis. Bronx county, New York, which is coterminous with the New York City borough of The Bronx, is an urban, medically underserved and economically depressed area, which is associated with an elevated relative rate of chronic diseases including obesity, diabetes, hypertension and cardiovascular disease. Over 70% of patients served by the Montefiore-Einstein Cancer Center (MECC) live beneath the poverty line suggesting that the patient population served by MECC is at risk for poor nutrition status.
With the goal of improving availability of evidence-based nutritional information to MECC patients, both in the active-treatment and survivorship settings, the study team has developed "RestoreMe," an easy-to-use mobile device application that provides nutrition education, personalized recommendations, recipes, exercises and more. RestoreMe also allows cancer patients and providers an easy-to-use resource with which to communicate directly with one another, which may increase patient engagement and compliance with their overall care.
In this study, the study team will investigate the regularity of app use by patients and which functions of the app are used effectively and most often. Usage trends specific to particular patient subgroups will also be evaluated. The results of this feasibility study will inform a future prospective interventional study using the RestoreMe app.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Other | Other: RestoreMe25 patients who prior to initiation of curative treatment. |
| Follow-up/Survivorship Care | Other | Other: RestoreMe25 patients who are in post-radiation therapy follow-up/survivorship care after completing definitive treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of invasive malignancy of the brain, head and neck region, lung, breast (DCIS and invasive disease allowed), prostate, gastrointestinal system or gynecological region
- Planned to receive, or have received, radiation therapy treatment with curative intent
- Patients must have a smartphone or other device with the ability to receive text messages, download and use mobile applications
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Ability to read and write in English
Key exclusion criteria (5 listed)
- Metastatic cancer
- Undergoing treatment with palliative intent
- Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL despite attempts to improve glucose control by fasting duration and adjustment of medications)
- Uncontrolled hypertension
- Any medical condition requiring fluid restriction or nutrient restrictions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RestoreMeComprehensive mobile device application | Other | Active Treatment, Follow-up/Survivorship Care |
Primary outcome
Patient Satisfaction
Time frame: Upon completion of treatment regimen or up to 12 months (+/1 month) after study entry
Patient satisfaction with the RestoreMe app will be measured using the Technology Acceptability Survey (TAS). The TAS consists of 10 questions including 7 quantitative items which will be used to assess Patient Satisfaction for the purposes of the study. Each of the 7 quantitative items on the survey represent a unique satisfaction parameter and are scored on a 5-point ordinal scale ranging from 1-5. Lower scores for an item correlate with increased satisfaction with the specific parameter and higher scores for an item correlate with decreased satisfaction for the specific parameter, yielding an overall possible scoring range of 7-35. Group scores will be summarized using basic descriptive statistics.
10 secondary outcomes
Frequency of Dailly Engagement - Patients
Time frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of Weekly Engagement - Patients
Time frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of Monthly Engagement - Patients
Time frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of Daily Engagement - Providers
Time frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of Weekly Engagement - Providers
Time frame: Up to approximately 12 months (+/1 month) after study entry
Frequency of Monthly Engagement - Providers
Time frame: Up to approximately 12 months (+/1 month) after study entry
Average Daily Interaction Time - Patients
Time frame: Up to approximately 12 months (+/1 month) after study entry
Average Weekly Interaction Time - Patients
Time frame: Up to approximately 12 months (+/1 month) after study entry
Average Monthly Interaction Time - Patients
Time frame: Up to approximately 12 months (+/1 month) after study entry
Drop-out over time.
Time frame: Up to approximately 12 months (+/1 month) after study entry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 26078410Gagnon MP, Ngangue P, Payne-Gagnon J, Desmartis M. m-Health adoption by healthcare professionals: a systematic review. J Am Med Inform Assoc. 2016 Jan;23(1):212-20. doi: 10.1093/jamia/ocv052. Epub 2015 Jun 15.
- BackgroundKamdar, Mihir M., et al.
- BackgroundLiu, Patrick, et al.
- Background: PubMed 24761773Mielck A, Vogelmann M, Leidl R. Health-related quality of life and socioeconomic status: inequalities among adults with a chronic disease. Health Qual Life Outcomes. 2014 Apr 25;12:58. doi: 10.1186/1477-7525-12-58.
- BackgroundNYS DOH. 2013-2014 NYS Expanded Behavioral Risk Factor Surveillance System, data as of 2015. Available: https://www.health.ny.gov/statistics/chac/general/g75.htm. Accessed 23 September 2016.
- Background: PubMed 12505249Pierce JP, Faerber S, Wright FA, Rock CL, Newman V, Flatt SW, Kealey S, Jones VE, Caan BJ, Gold EB, Haan M, Hollenbach KA, Jones L, Marshall JR, Ritenbaugh C, Stefanick ML, Thomson C, Wasserman L, Natarajan L, Thomas RG, Gilpin EA; Women's Healthy Eating and Living (WHEL) study group. A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: the Women's Healthy Eating and Living (WHEL) Study. Control Clin Trials. 2002 Dec;23(6):728-56. doi: 10.1016/s0197-2456(02)00241-6.
- Background: PubMed 24769692Chan DSM, Vieira AR, Aune D, Bandera EV, Greenwood DC, McTiernan A, Navarro Rosenblatt D, Thune I, Vieira R, Norat T. Body mass index and survival in women with breast cancer-systematic literature review and meta-analysis of 82 follow-up studies. Ann Oncol. 2014 Oct;25(10):1901-1914. doi: 10.1093/annonc/mdu042. Epub 2014 Apr 27.
- Background: PubMed 20571870Protani M, Coory M, Martin JH. Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis. Breast Cancer Res Treat. 2010 Oct;123(3):627-35. doi: 10.1007/s10549-010-0990-0. Epub 2010 Jun 23.
- Background: PubMed 21115856Ewertz M, Jensen MB, Gunnarsdottir KA, Hojris I, Jakobsen EH, Nielsen D, Stenbygaard LE, Tange UB, Cold S. Effect of obesity on prognosis after early-stage breast cancer. J Clin Oncol. 2011 Jan 1;29(1):25-31. doi: 10.1200/JCO.2010.29.7614. Epub 2010 Nov 29.
- Background: PubMed 11844838Chlebowski RT, Aiello E, McTiernan A. Weight loss in breast cancer patient management. J Clin Oncol. 2002 Feb 15;20(4):1128-43. doi: 10.1200/JCO.2002.20.4.1128.
- Background: PubMed 12711737Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.
- Background: PubMed 10378216Glade MJ. Food, nutrition, and the prevention of cancer: a global perspective. American Institute for Cancer Research/World Cancer Research Fund, American Institute for Cancer Research, 1997. Nutrition. 1999 Jun;15(6):523-6. doi: 10.1016/s0899-9007(99)00021-0. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafi Kabarriti, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RestoreMe in people with Mobile Applications and Cancer Patients, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafi Kabarriti, MD (914-629-7743, rkabarri@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Upon completion of treatment regimen or up to 12 months (+/1 month) after study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06860425, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.