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

Official title

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

Overview

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.

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

Interventions

• Other RestoreMe
  RestoreMe mobile device application

Primary outcome measures

• User satisfaction of RestoreMe application [Time frame: Every 4 weeks after enrollment until 12 months after study entry]

Secondary outcome measures (5)

• Feasibility of patient-generated health data collection using Garmin Vivofits- Step Counts [Time frame: First 6 weeks from 7th day after enrollment]
• Feasibility of patient-generated health data collection using Garmin Vivofits- Sedentary and Active Time [Time frame: First 6 weeks from 7th day after enrollment]
• Feasibility of patient-generated health data collection using Garmin Vivofits- Heart Rate [Time frame: First 6 weeks from 7th day after enrollment]
• Feasibility of patient-generated health data collection using iHealth Fit Nexus HS2S Weighing scale [Time frame: First 6 weeks from 7th day after enrollment]
• Feasibility of patient-generated health data collection using iHealth Track KN550BT blood pressure monitor [Time frame: First 6 weeks from 7th day after enrollment]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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- PMID 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. PMID 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. PMID 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. PMID 12122555

Identifiers

NCT: NCT07575685 · 2025-16965

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗