- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07011862
- Original Trial
COBRA: Cancer, Older Adults, Balance and Resistance Activities
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (Consent Only)
-
Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Consent Only)
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Suffolk-Commack (Consent only)
-
Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (Consent Only)
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center (All protocol activites)
-
Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau (Consent Only)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Older Adult Patients with Cancer
- Are within 1 year of completion of primary therapy for cancer OR have a diagnosis of metastatic cancer;
- For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy.
- Individuals with metastatic cancer may be included provided they have stable disease or better per most recent restaging exam at time of enrollment.
i. Patients with stable metastatic bony disease at most recent restaging exam and a score of 0-2 on the Functional Pain Scale (FPS69; Appendix 18) are eligible. The PI will consult with the Rehab Med co-PI for FPS scores of 3 or greater, by patient request or PI discretion.
ii. Patients with symptomatic visceral metastases will be evaluated on a case-by-case basis at time of enrollment.
- Are aged 65 years and older, with no upper age limit;
- ECOG PS 0-3 or Karnofsky PS greater than or equal to 40;
- Can read and speak English;
- Self-report access to internet connection sufficient to support videoconferencing.
Clinicians
- Licensed clinician (MD, RN, APP) with an interest in the care of older adults with cancer.
Exclusion Criteria:
Older Adult Patients with Cancer
- Have any cognitive impairment, neurologic, musculoskeletal, or other comorbid condition (as assessed by their provider) that would prevent the individual from engaging with the digital health coaching program or complete study assessments or engage in progressive intensity levels of physical activity
- Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to safely engage in progressive intensity levels of physical activity (as assessed by their provider). Patients with metastatic disease and suspected interim progression since last restaging exam will be referred back to their primary oncology care team for evaluation prior to enrollment.
- Have activity restrictions post-surgery at the time of enrollment
Clinicians No expected exclusions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Older Adult Patients/OAP
Older Adult Patients with Cancer are within 1 year of completion of primary therapy for cancer OR have a diagnosis of metastatic cancer;
|
The COBRA intervention is delivered as a web-based application through an iPad configured to allow access only to the study application and Zoom videoconferencing icons during the trial.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of retention and adherence to the COBRA/Cancer, Older Adults, Balance and Resistance Activities intervention
Time Frame: 8 weeks
|
Rate of retention and adherence to the 8-week intervention to define intervention feasibility
|
8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kristen Fessele, PhD, RN, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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