NCT04501913

Brief Summary

This study examines at-home monitoring of patient-generated phsyiologic health data and patient-reported outcomes. Patient-generated health data using at-home monitoring devices and smart device applications are used more and more to measure value and quality in cancer care. This trial may show whether at-home monitoring programs can improve the care of patients after hospital discharge from surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

5.8 years

First QC Date

May 21, 2020

Last Update Submit

December 3, 2025

Conditions

Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIB Gastric Cancer AJCC v8Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8Clinical Stage 0 Gastric Cancer AJCC v8Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage 0 Gastric Cancer AJCC v8Pathologic Stage I Esophageal Adenocarcinoma AJCC v8Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage I Gastric Cancer AJCC v8Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IA Gastric Cancer AJCC v8Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IB Gastric Cancer AJCC v8Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage II Gastric Cancer AJCC v8Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIA Gastric Cancer AJCC v8Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIB Gastric Cancer AJCC v8Pathologic Stage III Esophageal Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage III Gastric Cancer AJCC v8Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIA Gastric Cancer AJCC v8Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIC Gastric Cancer AJCC v8Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage I Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage I Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Stage 0 Colorectal Cancer AJCC v8Stage 0a Bladder Cancer AJCC v8Stage 0is Bladder Cancer AJCC v8Stage I Bladder Cancer AJCC v8Stage I Cervical Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage I Ovarian Cancer AJCC v8Stage I Prostate Cancer AJCC v8Stage I Renal Cell Cancer AJCC v8Stage I Uterine Corpus Cancer AJCC v8Stage IA Cervical Cancer AJCC v8Stage IA Ovarian Cancer AJCC v8Stage IA Uterine Corpus Cancer AJCC v8Stage IA1 Cervical Cancer AJCC v8Stage IA2 Cervical Cancer AJCC v8Stage IB Cervical Cancer AJCC v8Stage IB Ovarian Cancer AJCC v8Stage IB Uterine Corpus Cancer AJCC v8Stage IB1 Cervical Cancer AJCC v8Stage IB2 Cervical Cancer AJCC v8Stage IC Ovarian Cancer AJCC v8Stage II Bladder Cancer AJCC v8Stage II Cervical Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Ovarian Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage II Renal Cell Cancer AJCC v8Stage II Uterine Corpus Cancer AJCC v8Stage IIA Cervical Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIA Ovarian Cancer AJCC v8Stage IIA Prostate Cancer AJCC v8Stage IIA1 Cervical Cancer AJCC v8Stage IIA2 Cervical Cancer AJCC v8Stage IIB Cervical Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIB Ovarian Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8Stage III Bladder Cancer AJCC v8Stage III Cervical Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage III Renal Cell Cancer AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage IIIA Bladder Cancer AJCC v8Stage IIIA Cervical Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Bladder Cancer AJCC v8Stage IIIB Cervical Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IV Bladder Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Prostate Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IV Uterine Corpus Cancer AJCC v8Stage IVA Bladder Cancer AJCC v8Stage IVA Cervical Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVB Bladder Cancer AJCC v8Stage IVB Cervical Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8Clinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage I Gastric Cancer AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage II Gastric Cancer AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIA Gastric Cancer AJCC v8Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8Clinical Stage IIB Gastric Cancer AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Hepatobiliary NeoplasmMalignant Digestive System NeoplasmMalignant Female Reproductive System NeoplasmMalignant Genitourinary System NeoplasmMalignant NeoplasmPathologic Stage 0 Esophageal Adenocarcinoma AJCC v8Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (15)

  • Overall accrual

    Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.

    Days 2

  • Overall accrual

    Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.

    Days 7

  • Overall accrual

    Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.

    Days 14

  • Overall accrual

    Planned accrual is bound by the number of eligibile patients and duration of the study funding. Accrual goal is 20 patients.

    Days 30 after discharge

  • Retention

    Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.

    Days 2

  • Retention

    Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.

    Days 7

  • Retention

    Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.

    Days 14

  • Retention

    Participants' retention will be assessed at all follow-up timepoints by remaining enrolled on study.

    Days 30 after discharge

  • Attrition rates

    All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.

    Days 2

  • Attrition rates

    All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.

    Days 7

  • Attrition rates

    All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.

    Days 14

  • Attrition rates

    All participants that are enrolled will be tracked and assessed for drop off (attrition) at all time points.

    Days 30 after discharge

  • Patient's ability to use the remote perioperative monitoring equipment

    At least 75% of patients will be able to wear the wristband pedometer for at least 1 week post-operatively, and at least 75% of the patients will be able to use at least 2 out of 4 physiologic devices (scale, pulse/heart monitor, blood pressure cuff, and thermometer) at least once a week.

    Up to 30 days

  • Staff ability to identify threshold healthcare parameters

    Staff will be alerted through a workflow guided by the threshold healthcare parameters. The number of alerts of data outside parameters will be recorded as well as the initiated response to each alert.

    Up to 30 days

  • Staff ability to act on identified threshold healthcare parameters

    The number of alerts and resolved alerts will be captured in response to threshold parameters in addition to a nurse debriefing form to summarize the response

    Up to 30 days

Secondary Outcomes (3)

  • Patterns, trajectory, and changes in patient-generated health data (PGHD)

    Up to 30 days

  • Patient reported outcomes (PROs) (symptoms, quality of life [QOL]) between groups

    From pre-surgery to the post-discharge period

  • Changes in PGHD/PROs

    Up to 30 days after surgery

Study Arms (1)

Observational (remote telemonitoring)

Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.

Procedure: Patient MonitoringOther: Questionnaire Administration

Interventions

Patient MonitoringPROCEDURE

Undergo remote perioperative telemonitoring

Also known as: medical monitoring, monitor
Observational (remote telemonitoring)
Questionnaire AdministrationOTHER

Complete questionnaires

Observational (remote telemonitoring)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients diagnosed with gastrointestinal, genitourinary, or gynecological cancers who are scheduled to undergo abdominal/pelvic surgery at the City of Hope National Medical Center

You may qualify if:

  • Cancer patients diagnosed with GI (esophagus, gastric, colorectal, hepatobiliary) GU (prostate, bladder, renal cell), or GYN (ovarian, endometrial, cervical) cancers
  • Patients who are scheduled to undergo major abdominal/pelvic surgery for cancer treatment
  • Ability to read and understand English
  • We are targeting patients across all stages of disease
  • All subjects must have the ability to understand and the willingness to sign a written informed consent

You may not qualify if:

  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsUrogenital NeoplasmsNeoplasmsColorectal NeoplasmsUrinary Bladder NeoplasmsUterine Cervical NeoplasmsOvarian NeoplasmsProstatic NeoplasmsCarcinoma, Renal Cell

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsKidney Diseases

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Laleh Melstrom

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

August 6, 2020

Study Start

December 24, 2019

Primary Completion

October 17, 2025

Study Completion

October 17, 2025

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations

US(1)