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ReVital-CORE Program

ReVital Chemotherapy Online Resiliency Evaluation (ReVital-CORE) Program Pilot Feasibility Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04852575
Acronym
ReVital-CORE
Enrollment
141
Registered
2021-04-21
Start date
2021-01-25
Completion date
2023-01-25
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Chemotherapy-Induced Change, Frailty

Keywords

Frailty, Cancer, Chemotherapy, Care coordination, Online, Prospective surveillance

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.

Detailed description

All patients starting a new chemotherapy regimen will be referred to completed a prehab evaluation with a specialized physical or occupational therapist be and invited to enroll in the ReVital-CORE program for the pilot, feasibility study. Participants in the ReVital-CORE program study will be emailed an online evaluation each month via for one year. Once completed, the evaluation is automatically scored into: frail, pre-frail or robust categories using a validated frailty index. Any patient categorized as frail or pre-frail will be re-referred to rehabilitation by their cancer care team. For frail and pre-frail individuals, standard of care rehabilitation therapy will include either/and occupational and physical therapy evaluation and treatment and will be billed via their insurance. The purpose of this pilot study is to evaluate feasibility of the of the ReVital-CORE Program for individuals starting a new chemotherapy regimen. Secondary aims are to evaluate the prevalence, trajectory and predictors of frailty during the first year of chemotherapy treatment; and evaluate the impacts of prehab/rehabilitation for participants identified as frail and pre-frail.

Interventions

None listed

Sponsors

Select Medical
CollaboratorUNKNOWN
Kessler Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* Eligible for hospice care

Design outcomes

Primary

MeasureTime frameDescription
Accrual to the ReVital-CORE program.02/2022Proportion of patients who consent to enroll, out of the total number invited.

Secondary

MeasureTime frameDescription
Prevalence of frailty at major time points.02/2023Proportion of participants at all major timepoints (pre-chemo, and monthly following start of chemo for 12 months) who are identified as frail or pre-frail by a patient-reported frailty index.
Impact of therapy on global quality of life.02/2023Change from baseline to discharge in quality of life as measured by the Patient Reported Outcomes Measuring System (PROMIS)-global 10-item questionnaire.
Impact of therapy on frailty.02/2023Change from baseline to discharge in frailty as measured by a patient-reported frailty index.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026