Clinical trial NCT07011862: COBRA: Cancer, Older Adults, Balance and Resistance Activities
Official title: COBRA: Cancer, Older Adults, Balance and Resistance Activities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Cancer
Metastatic Cancer
Cancer
Keywords: Primary Cancer
Metastatic Cancer
Cancer
25-090
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of retention and adherence to the COBRA/Cancer, Older Adults, Balance and Resistance Activities intervention
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activites)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kristen Fessele, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: