16 Participants NeededMy employer runs this trial

GA-STOMA for Ostomy

CC
JZ
Overseen ByJana Zeineddine, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this pilot study is to learn if an intervention in patients undergoing ostomy surgery is easy to use. The overall goal of the work is to improve quality of life during recovery in the days after surgery for these patients using the intervention.

Who Is on the Research Team?

CC

Christy Cauley, MD, MPH

Principal Investigator

MassGeneral Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 65 and older who are having fecal ostomy surgery, as well as their clinicians. People with cognitive problems that prevent them from understanding the consent process cannot join.

Inclusion Criteria

I am 65 years old or older.
I am a clinician who is 18 years old or older.
I am having fecal ostomy surgery or I am a clinician caring for such patients.

Exclusion Criteria

I am able to understand and agree to the study after it is explained to me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a web-based intervention in addition to routine surgical care

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)

Trial Overview

The study is testing a new geriatric assessment strategy (GA-STOMA) to help older adults manage and adapt after ostomy surgery. The main goal is to see if this approach is easy to use during recovery.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: GA-STOMAExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+