COBRA: Cancer, Older Adults, Balance and Resistance Activities

Not Applicable

Recruiting

• Conditions: Primary Cancer; Metastatic Cancer; Cancer

• Registration Number: NCT07011862
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2027-05-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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;

1. 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.
2. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of retention and adherence to the COBRA/Cancer, Older Adults, Balance and Resistance Activities intervention	8 weeks	Rate of retention and adherence to the 8-week intervention to define intervention feasibility

Trial Locations

Locations (6)

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Consent Only); 🇺🇸 Uniondale, New York, United States