FrailtyReVital-CORENCT04852575
ReVital-CORE Program
An observational study of Frailty and Cancer, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Cancer, Chemotherapy-Induced Change
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 25 Jan 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Individuals diagnosed with cancer who are starting a new chemotherapy regimen (note: can be any line of chemotherapy)
Who may be able to join
- Aged 18 years or older
- English speaking
- Starting new chemotherapy treatment with oncology partner
- Provide informed consent
Who cannot join
- Eligible for hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: ReVital Chemotherapy Online Resiliency Evaluation (ReVital-CORE) Program Pilot Feasibility Study
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.
Read the 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.
- Conditions
- Frailty, Cancer, Chemotherapy-Induced Change
- Keywords
- Frailty, Cancer, Chemotherapy, Care coordination, Online, Prospective surveillance
- Medical subject headings
- Frailty, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual to the ReVital-CORE program.
Proportion of patients who consent to enroll, out of the total number invited.
Measured: 02/2022
Secondary outcomes (3)
Prevalence of frailty at major time points.
Proportion 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.
Measured: 02/2023
Impact of therapy on global quality of life.
Change from baseline to discharge in quality of life as measured by the Patient Reported Outcomes Measuring System (PROMIS)-global 10-item questionnaire.
Measured: 02/2023
Impact of therapy on frailty.
Change from baseline to discharge in frailty as measured by a patient-reported frailty index.
Measured: 02/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start25 Jan 2021
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Select Medical
- Responsible party
- Principal investigator, Mackenzi Pergolotti, Kessler Foundation
- Investigators
- Mackenzi Pergolotti, PhD, Principal investigator, Select Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852575
- Sponsor's protocol ID
- E-1132-20
- Acronym
- ReVital-CORE
- Status last verified
- Nov 2023
- First submitted
- 1 Mar 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReVital Chemotherapy Online Resiliency Evaluation (ReVital-CORE) Program Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT04852575
- Acronym / sponsor ID
- ReVital-CORE / E-1132-20
- Conditions
- Frailty, Cancer, Chemotherapy-Induced Change
- Keywords
- Frailty, Cancer, Chemotherapy, Care coordination, Online, Prospective surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Select Medical
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with cancer who are starting a new chemotherapy regimen (note: can be any line of chemotherapy)
Key inclusion criteria (4 listed)
- Aged 18 years or older
- English speaking
- Starting new chemotherapy treatment with oncology partner
- Provide informed consent
Key exclusion criteria (1 listed)
- Eligible for hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accrual to the ReVital-CORE program.
Time frame: 02/2022
Proportion of patients who consent to enroll, out of the total number invited.
3 secondary outcomes
Prevalence of frailty at major time points.
Time frame: 02/2023
Impact of therapy on global quality of life.
Time frame: 02/2023
Impact of therapy on frailty.
Time frame: 02/2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mackenzi Pergolotti, PhD principal investigator
Select Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Cancer, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual to the ReVital-CORE program. (time frame: 02/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.