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Nutrition Aspect of CancerRestoreMeNCT07575685

Enhancing Cancer Care: RestoreMe App for Personalized Nutrition and Activity in Cancer Patients

A study testing RestoreMe in people with Nutrition Aspect of Cancer and Cancer, run by Montefiore Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a single institution feasibility study of the updated RestoreMe app. The investigators plan to recruit 150 participants to this study with participants being recruited either prior to the initiation of their curative treatment or during and after completion of their cancer therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RestoreMe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
Oct 2026to Oct 2035
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

  • Age > 18
  • Planned to receive, or have received, cancer treatments including radiation therapy, chemotherapy, immunotherapy, or surgery
  • Must have a smartphone or other device with the ability to receive text messages, download and use mobile applications.
  • Ability to read and write English
  • Provide written informed consent to participate in the study.
  • Concurrent enrollment on other trials is permitted.

Who cannot join

  • Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL despite attempts to improve glucose control by fasting duration and adjustment of medications).
  • Any medical condition requiring fluid restriction or nutrient restrictions.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Rafi Kabarriti, MD contact

7184302000

rkabarri@montefiore.org

About this study

Official title: Enhancing Cancer Care: RestoreMe Application for Personalized Nutrition and Activity in Cancer Patients

This is a single institution feasibility study of the updated RestoreMe app. The investigators plan to recruit 150 participants to this study with participants being recruited either prior to the initiation of their curative treatment or during and after completion of their cancer therapy. This design will allow the investigators to assess the feasibility of using the RestoreMe app in both the active treatment setting and follow up/survivorship setting. Information gathered from this feasibility study will inform future trial design for prospective intervention using the RestoreMe app.

Read the detailed description

Building on user experience data from the first version of the application, the investigators have enhanced the "RestoreMe" appl to offer an even more refined experience. The updated version incorporates valuable feedback, resulting in improved functionality, more personalized features, and a more intuitive design. It also allows for connectivity to Bluetooth devices and Apple health integration to obtain weight, blood pressure, heart rate, temperature, and step counts. It features customized questionnaires [Patient Reported Outcomes (PROs)] and relevant patient information including Body Mass Index, cancer diagnosis/treatment, and preferences/restrictions to evaluate nutritional status and provide personalized and curated recommendations regarding nutrition (calorie requirements, superfoods, weekly meal plans, shopping lists, supplements), hydration, physical activity and disease education/navigation.

The investigators believe that collection of patient-generated health data, which includes physical activity metrics, physiologic data (e.g., heart rate), and PROs and their integration with symptom reporting and nutritional assessments will significantly enhance the RestoreMe® app enabling it to provide tailored diet, hydration and activity recommendations, robust personalized learning section (disease specific and curated), provide remote symptom and activity monitoring, and promote self-management (through goals and progress). The implementation of RestoreMe® in diverse populations, such as those in the Bronx, has the potential to significantly improve cancer care outcomes. These populations often face additional barriers, including language and cultural differences, that further complicate nutritional management. Multi-language translation, food preferences/restrictions, caregiver engagement and easy-to-use features are built in RestoreMe® to address these barriers.

The investigators expect that most study participants will be enrolled during their visits. At the time of study enrollment, subjects will be provided with access to the RestoreMe app and the devices listed below. Participants will receive a written guide as well as training on device use. Of note, these devices will be provided with no cost to study participants. These devices (with the exception of Garmin Vivofits, which participants can keep and use as long as they wish) will be returned at the time of study completion, either during an in-person clinic visit or using pre-packaged shipping materials.

  • Garmin Vivofits
  • iHealth Fit Nexus HS2S Weighing scale
  • iHealth Track KN550BT blood pressure monitor
Being tested
RestoreMe
Keywords
Patient Reported Outcomes, Biomarker, Activity
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RestoreMeOther

    RestoreMe mobile device application

Study groups in NCT07575685
Study groupRoleWhat they receive
InterventionExperimentalRestoreMe mobile phone application for cancer patients undergoing active cancer therapy or in follow-up/survivorship care
Receives: Other: RestoreMe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. User satisfaction of RestoreMe application

    To evaluate user satisfaction of RestoreMe app in delivering ongoing nutritional education and personalized dietary recommendations for cancer patients undergoing active cancer therapy or in follow-up/survivorship care as measured by the Technology Acceptability Survey. The overall satisfaction score at 4 weeks will be calculated from adding the scores of 10 individual scorable items (Score range: 10-50) on the Technology Acceptability Survey. The overall score of 3 or below is considered satisfactory. To estimate the mean overall score, we will calculate 95% t-confidence interval. As secondary analyses, we will calculate the confidence intervals for different time points and for individual items.

    Measured: Every 4 weeks after enrollment until 12 months after study entry

Secondary outcomes (5)
  1. Feasibility of patient-generated health data collection using Garmin Vivofits- Step Counts

    Participants will be asked to wear the Garmin Vivofits continuously during the study period. Data collected using the Garmin Vivofits will include step counts. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval.

    Measured: First 6 weeks from 7th day after enrollment

  2. Feasibility of patient-generated health data collection using Garmin Vivofits- Sedentary and Active Time

    Participants will be asked to wear the Garmin Vivofits continuously during the study period. Data collected using the Garmin Vivofits will include measures of sedentary and active time. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval.

    Measured: First 6 weeks from 7th day after enrollment

  3. Feasibility of patient-generated health data collection using Garmin Vivofits- Heart Rate

    Participants will be asked to wear the Garmin Vivofits continuously during the study period. Data collected using the Garmin Vivofits will include heart rate. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval.

    Measured: First 6 weeks from 7th day after enrollment

  4. Feasibility of patient-generated health data collection using iHealth Fit Nexus HS2S Weighing scale

    Participants will be asked to use the iHealth Fit Nexus HS2S Weighing scale once a week during the study period. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval.

    Measured: First 6 weeks from 7th day after enrollment

  5. Feasibility of patient-generated health data collection using iHealth Track KN550BT blood pressure monitor

    Participants will be asked to use iHealth Track KN550BT blood pressure monitor once a week during the study period. The investigators will calculate the rate of collecting measurements from more than 50% of the subjects. They define the rate as measurement-specific feasibility rate. To estimate the rate, they will calculate 95% exact binomial confidence interval.

    Measured: First 6 weeks from 7th day after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2035 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive the same intervention
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07575685
Sponsor's protocol ID
2025-16965
Other IDs
2025
Acronym
RestoreMe
Status last verified
Sep 2026
First submitted
4 May 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zheng C, Chen X, Weng L, Guo L, Xu H, Lin M, Xue Y, Lin X, Yang A, Yu L, Xue Z, Yang J. Benefits of Mobile Apps for Cancer Pain Management: Systematic Review. JMIR Mhealth Uhealth. 2020 Jan 23;8(1):e17055. doi: 10.2196/17055.

    PubMed 32012088
  • Liu P, Astudillo K, Velez D, Kelley L, Cobbs-Lomax D, Spatz ES. Use of Mobile Health Applications in Low-Income Populations: A Prospective Study of Facilitators and Barriers. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e007031. doi: 10.1161/CIRCOUTCOMES.120.007031. Epub 2020 Sep 4. No abstract available.

    PubMed 32885681
  • 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 26078410
  • Chang CM, Su YC, Lai NS, Huang KY, Chien SH, Chang YH, Lian WC, Hsu TW, Lee CC. The combined effect of individual and neighborhood socioeconomic status on cancer survival rates. PLoS One. 2012;7(8):e44325. doi: 10.1371/journal.pone.0044325. Epub 2012 Aug 30.

    PubMed 22957007
  • Paccagnella A, Morello M, Da Mosto MC, Baruffi C, Marcon ML, Gava A, Baggio V, Lamon S, Babare R, Rosti G, Giometto M, Boscolo-Rizzo P, Kiwanuka E, Tessarin M, Caregaro L, Marchiori C. Early nutritional intervention improves treatment tolerance and outcomes in head and neck cancer patients undergoing concurrent chemoradiotherapy. Support Care Cancer. 2010 Jul;18(7):837-45. doi: 10.1007/s00520-009-0717-0. Epub 2009 Aug 30.

    PubMed 19727846
  • Kabarriti R, Bontempo A, Romano M, McGovern KP, Asaro A, Viswanathan S, Kalnicki S, Garg MK. The impact of dietary regimen compliance on outcomes for HNSCC patients treated with radiation therapy. Support Care Cancer. 2018 Sep;26(9):3307-3313. doi: 10.1007/s00520-018-4198-x. Epub 2018 Apr 18.

    PubMed 29671062
  • Trujillo EB, Claghorn K, Dixon SW, Hill EB, Braun A, Lipinski E, Platek ME, Vergo MT, Spees C. Inadequate Nutrition Coverage in Outpatient Cancer Centers: Results of a National Survey. J Oncol. 2019 Nov 22;2019:7462940. doi: 10.1155/2019/7462940. eCollection 2019.

    PubMed 31885583
  • Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.

    PubMed 12122555
  • Liptrott S, Bee P, Lovell K. Acceptability of telephone support as perceived by patients with cancer: A systematic review. Eur J Cancer Care (Engl). 2018 Jan;27(1). doi: 10.1111/ecc.12643. Epub 2017 Jan 30.

    PubMed 28134475
  • Capra S, Ferguson M, Ried K. Cancer: impact of nutrition intervention outcome--nutrition issues for patients. Nutrition. 2001 Sep;17(9):769-72. doi: 10.1016/s0899-9007(01)00632-3.

    PubMed 11527676
  • Ryan AM, Power DG, Daly L, Cushen SJ, Ni Bhuachalla E, Prado CM. Cancer-associated malnutrition, cachexia and sarcopenia: the skeleton in the hospital closet 40 years later. Proc Nutr Soc. 2016 May;75(2):199-211. doi: 10.1017/S002966511500419X. Epub 2016 Jan 20.

    PubMed 26786393
  • Ohri N, Kabarriti R, Bodner WR, Mehta KJ, Shankar V, Halmos B, Haigentz M Jr, Rapkin B, Guha C, Kalnicki S, Garg M. Continuous Activity Monitoring During Concurrent Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2017 Apr 1;97(5):1061-1065. doi: 10.1016/j.ijrobp.2016.12.030. Epub 2016 Dec 25.

    PubMed 28332990
  • Paul S, Bodner WR, Garg M, Tang J, Ohri N. Cardiac Irradiation Predicts Activity Decline in Patients Receiving Concurrent Chemoradiation for Locally Advanced Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):597-601. doi: 10.1016/j.ijrobp.2020.05.042. Epub 2020 Jun 1.

    PubMed 32497682
  • Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.

    PubMed 7168798

Questions about this trial

What is this clinical trial studying?

A study testing RestoreMe in people with Nutrition Aspect of Cancer and Cancer, run by Montefiore Medical Center.

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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 (7184302000, rkabarri@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

User satisfaction of RestoreMe application (time frame: Every 4 weeks after enrollment until 12 months 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 NCT07575685, which also lists 14 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 11 Sep 2026.

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