COBRA: Cancer, Older Adults, Balance and Resistance Activities

NCT ID: NCT07011862

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2027-05-30

Brief Summary

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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

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Conditions

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Primary Cancer Metastatic Cancer Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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;

Group Type EXPERIMENTAL

Cancer, Older adults, Balance and Resistance Activities

Intervention Type BEHAVIORAL

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.

Interventions

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Cancer, Older adults, Balance and Resistance Activities

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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COBRA

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristen Fessele, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Consent Only)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristen Fessele, PhD, RN

Role: CONTACT

646-449-1076

Grigory Syrkin, MD

Role: CONTACT

212-639-2397

Facility Contacts

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Kristen Fessele, PhD, RN

Role: primary

646-449-1076

Kristen Fessele, PhD, RN

Role: primary

646-449-1076

Kristen Fessele, PhD, RN

Role: primary

646-449-1076

Kristen Fessele, PhD, RN

Role: primary

646-449-1076

Kristen Fessele, PhD, RN

Role: primary

646-449-1076

Kristen Fessele, PhD, RN

Role: primary

646-449-1076

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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25-090

Identifier Type: -

Identifier Source: org_study_id

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