Recruiting

Observational Study

Sponsor:

Montefiore Medical Center

Code:

NCT06860425

Conditions

Mobile Applications

Cancer Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RestoreMe

Study Details

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

Study ID

NCT06860425

Start date

Feb 28, 2023

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Active Treatment

25 patients who prior to initiation of curative treatment.

other: Follow-up/Survivorship Care

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

Interventions

RestoreMe

Comprehensive mobile device application

Primary outcome measure

  • Patient Satisfaction [ Time Frame: Upon completion of treatment regimen or up to 12 months (+/1 month) after study entry ]

Central Contacts and Locations

Central contacts

Rafi Kabarriti, MD

914-629-7743rkabarri@montefiore.org

Rikin Gandhi

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

Locations

Montefiore Einstein Comprehensive Cancer Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Rafi Kabarriti, MD

914-629-7743rkabarri@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Keywords

  • Diet
  • Nutrition
  • Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-02-24.