COBRA: Cancer, Older Adults, Balance and Resistance Activities
1 other identifier
interventional
38
1 country
6
Brief Summary
The purpose of this study is to find out whether an 8-week digital health promotion program called COBRA is a safe and practical (feasible) option for older adults with cancer/OAC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2025
CompletedFirst Submitted
Initial submission to the registry
June 2, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
April 24, 2026
April 1, 2026
2 years
June 2, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of retention and adherence to the COBRA/Cancer, Older Adults, Balance and Resistance Activities intervention
Rate of retention and adherence to the 8-week intervention to define intervention feasibility
8 weeks
Study Arms (1)
Older Adult Patients/OAP
EXPERIMENTALOlder Adult Patients with Cancer are within 1 year of completion of primary therapy for cancer OR have a diagnosis of metastatic cancer;
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen Fessele, PhD, RN
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2025
First Posted
June 10, 2025
Study Start
May 30, 2025
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.