Recruiting

Digital Health Promotion Program for Older Adults with Cancer

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What is being tested

Cancer, Older adults, Balance and Resistance Activities

Behavioral
Who is being recruted

Primary Cancer

+ Metastatic Cancer
+ Cancer
Over 65 Years
+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: May 2025

See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Study ContactKristen Fessele, PhD, RN
Last updated: June 10, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 30, 2025Actual date on which the first participant was enrolled.

This study explores whether a digital health program called COBRA is a safe and practical option for older adults who have cancer. The focus is on using balance and resistance activities to help these individuals. The study aims to assess if such a program can be effectively used by this age group, providing an important step in improving supportive care and quality of life for older cancer patients. Participants in the study will engage in an 8-week digital health program specifically designed for them. The program will likely include activities that promote balance and resistance, which are crucial for maintaining strength and stability. Researchers will monitor the participants to evaluate the feasibility and safety of the program, ensuring it is a suitable option for older adults with cancer. While specific risks and benefits are not detailed, the study is crucial for understanding how to better support the health and well-being of this population.

Official TitleCOBRA: Cancer, Older Adults, Balance and Resistance Activities 
Principal SponsorMemorial Sloan Kettering Cancer Center
Study ContactKristen Fessele, PhD, RN
Last updated: June 10, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
38 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Primary Cancer
Metastatic Cancer
Cancer
Criteria
12 inclusion criteria required to participate
lder 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

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5 exclusion criteria prevent from participating
lder 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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Older Adult Patients with Cancer are within 1 year of completion of primary therapy for cancer OR have a diagnosis of metastatic cancer;
Study Objectives
Primary Objectives

Rate of retention and adherence to the 8-week intervention to define intervention feasibility

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 6 locations
Recruiting
Memorial Sloan Kettering Monmouth (Consent only)Middletown, United StatesSee the location
Recruiting
Memorial Sloan Kettering Bergen (Consent Only)Montvale, United States
Recruiting
Memorial Sloan Kettering Suffolk-Commack (Consent Only)Commack, United States
Recruiting
Memorial Sloan Kettering Westchester (Consent only)Harrison, United States
Recruiting
6 Study Centers