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

2026년 5월 4일 업데이트: Montefiore Medical Center

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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

연구 유형

중재적

등록 (추정된)

150

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention
RestoreMe mobile phone application for cancer patients undergoing active cancer therapy or in follow-up/survivorship care
다른: RestoreMe
RestoreMe mobile device application

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
User satisfaction of RestoreMe application
기간: Every 4 weeks after enrollment until 12 months after study entry
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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Montefiore Medical Center

수사관

  • 수석 연구원: Rafi R Kabarriti, MD, Montefiore Medical Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 1일

기본 완료 (추정된)

2030년 5월 1일

연구 완료 (추정된)

2035년 5월 1일

연구 등록 날짜

최초 제출

2026년 5월 4일

QC 기준을 충족하는 최초 제출

2026년 5월 4일

처음 게시됨 (실제)

2026년 5월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 4일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-16965

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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약물 개입

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위치

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