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

NCT07575685 | Not Yet Recruiting DMC

• 1 other identifier: 2025-16965
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Nutrition Aspect of Cancer; Cancer; Dietary Recommendations; Mobile Applications

Keywords

Patient Reported Outcomes; Biomarker; Activity

Outcome Measures

Primary Outcomes (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.

  Every 4 weeks after enrollment until 12 months after study entry

Secondary Outcomes (5)

• Feasibility of patient-generated health data collection using Garmin Vivofits- Step Counts

  First 6 weeks from 7th day after enrollment

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

  First 6 weeks from 7th day after enrollment

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

  First 6 weeks from 7th day after enrollment

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

  First 6 weeks from 7th day after enrollment

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

  First 6 weeks from 7th day after enrollment

Study Arms (1)

Intervention

EXPERIMENTAL

RestoreMe mobile phone application for cancer patients undergoing active cancer therapy or in follow-up/survivorship care

Other: RestoreMe

Interventions

RestoreMe OTHER

RestoreMe mobile device application

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Related Publications (14)

• 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.

  PMID: 32012088 BACKGROUND

• 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.

  PMID: 32885681 BACKGROUND

• 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.

  PMID: 26078410 BACKGROUND

• 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.

  PMID: 22957007 BACKGROUND

• 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.

  PMID: 19727846 BACKGROUND

• 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.

  PMID: 29671062 BACKGROUND

• 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.

  PMID: 31885583 BACKGROUND

• 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.

  PMID: 12122555 BACKGROUND

• 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.

  PMID: 28134475 BACKGROUND

• 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.

  PMID: 11527676 BACKGROUND

• 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.

  PMID: 26786393 BACKGROUND

• 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.

  PMID: 28332990 BACKGROUND

• 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.

  PMID: 32497682 BACKGROUND

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

  PMID: 7168798 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rafi R Kabarriti, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafi Kabarriti, MD

CONTACT

7184302000; rkabarri@montefiore.org

Akash Shah

CONTACT

7184302000; ashah1@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the same intervention

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2035
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share