NCT04852575

Brief Summary

Pilot feasibility study of the ReVital Chemotherapy Online Resiliency Evaluation (CORE) program. As part of standard of care, patients starting a new chemotherapy regimen are referred to complete a pre-chemotherapy cancer rehabilitation evaluation (i.e., prehab) and invited to enroll in the ReVital-CORE program study. Once enrolled in ReVital-CORE, participants will complete a monthly online evaluation for 1 year. If frailty (or pre-frailty) is detected on any survey, physical or occupational therapy will be initiated for standard of care rehabilitation evaluation and treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

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

January 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

March 1, 2021

Last Update Submit

November 16, 2023

Conditions

FrailtyCancerChemotherapy-Induced Change

Keywords

FrailtyCancerChemotherapyCare coordinationOnlineProspective surveillance

Outcome Measures

Primary Outcomes (1)

  • Accrual to the ReVital-CORE program.

    Proportion of patients who consent to enroll, out of the total number invited.

    02/2022

Secondary Outcomes (3)

  • Prevalence of frailty at major time points.

    02/2023

  • Impact of therapy on global quality of life.

    02/2023

  • Impact of therapy on frailty.

    02/2023

Eligibility Criteria

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

Individuals diagnosed with cancer who are starting a new chemotherapy regimen (note: can be any line of chemotherapy)

You may qualify if:

  • Aged 18 years or older
  • English speaking
  • Starting new chemotherapy treatment with oncology partner
  • Provide informed consent

You may not qualify if:

  • Eligible for hospice care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

FrailtyNeoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mackenzi Pergolotti, PhD

    Select Medical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Director, Research and Clinical Development

Study Record Dates

First Submitted

March 1, 2021

First Posted

April 21, 2021

Study Start

January 25, 2021

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers.

Locations

US(1)