Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity

NCT06860425 | Recruiting

• 1 other identifier: 2022-13979
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mobile Applications; Cancer Patients

Keywords

Diet; Nutrition; Activity

Outcome Measures

Primary Outcomes (1)

• 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.

  Upon completion of treatment regimen or up to 12 months (+/1 month) after study entry

Secondary Outcomes (10)

• Frequency of Dailly Engagement - Patients

  Up to approximately 12 months (+/1 month) after study entry

• Frequency of Weekly Engagement - Patients

  Up to approximately 12 months (+/1 month) after study entry

• Frequency of Monthly Engagement - Patients

  Up to approximately 12 months (+/1 month) after study entry

• Frequency of Daily Engagement - Providers

  Up to approximately 12 months (+/1 month) after study entry

• Frequency of Weekly Engagement - Providers

  Up to approximately 12 months (+/1 month) after study entry

Study Arms (2)

Active Treatment

OTHER

25 patients who prior to initiation of curative treatment.

Other: RestoreMe

Follow-up/Survivorship Care

OTHER

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

Other: RestoreMe

Interventions

RestoreMe OTHER

Comprehensive mobile device application

Active Treatment; Follow-up/Survivorship Care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rafi Kabarriti, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafi Kabarriti, MD

CONTACT

914-629-7743; rkabarri@montefiore.org

Rikin Gandhi

CONTACT

617-416-1216; rikin.gandhi@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 6, 2025
• Study Start: February 28, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)