Ostomy - Ileostomy or ColostomyEarly Phase 1NCT07424586
Improving Outcomes of Older Adults Undergoing Ostomy Surgery
A Early Phase 1 study testing Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA) in people with Ostomy - Ileostomy or Colostomy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy - Ileostomy or Colostomy
- What is being tested?
- Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2026to 30 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients Age 65+ years
- clinicians age 18+ years
- Patients undergoing fecal ostomy surgery and their clinicians
Who cannot join
- cognitive impairment not allowing completion of consent procedures based on the teach-back method.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MassGeneral Hospital
Boston, Massachusetts, 02114
Christy Cauley, MD, MPH, 617-726-8129, ccauley@mgb.org
Christy Cauley, MD, MPH
About this study
Official title: Improving Biopsychosocial Outcomes of Older Adults Undergoing Fecal Ostomy Surgery
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.
Read the detailed description
In this study the acceptability and usability of an intervention to evaluate and address biopsychosocial outcomes for older adults undergoing fecal ostomy surgery will be evaluated with the overall goal of improving patient-centered outcomes.
- Conditions
- Ostomy - Ileostomy or Colostomy
- Being tested
- Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)
- Keywords
- ostomy, quality of life, biopsychosocial outcomes, web-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)Behavioural
The web-based intervention provides patients with a survey and tailored content with the purpose of better supporting recovery and adaptation after surgery with a fecal ostomy
| Study group | Role | What they receive |
|---|---|---|
| GA-STOMA | Experimental | A web-based intervention will be provided in addition to routine surgical care. Receives: Behavioral: Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Interviews will be performed to assess the ability to use the intervention, complete questions, obtain management recommendations and complete management recommendations.
Measured: 6 weeks
Secondary outcomes (1)
Client Satisfaction questionnaire
This is a quantitative evaluation of intervention acceptability
Measured: 6 weeks after surgery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start11 Feb 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ostomy - Ileostomy or ColostomyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Pilot of patients and clinicians to assess web-based intervention acceptability and usability.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Christy E. Cauley, MD, MPH, Massachusetts General Hospital
- Investigators
- Christy Cauley, MD, MPH, Principal investigator, MassGeneral Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424586
- Sponsor's protocol ID
- 2025P002770
- Other IDs
- K76AG088346
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Biopsychosocial Outcomes of Older Adults Undergoing Fecal Ostomy Surgery
- ClinicalTrials.gov ID
- NCT07424586
- Acronym / sponsor ID
- 2025P002770
- Conditions
- Ostomy - Ileostomy or Colostomy
- Keywords
- ostomy, quality of life, biopsychosocial outcomes, web-based intervention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study the acceptability and usability of an intervention to evaluate and address biopsychosocial outcomes for older adults undergoing fecal ostomy surgery will be evaluated with the overall goal of improving patient-centered outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Pilot of patients and clinicians to assess web-based intervention acceptability and usability.
| Arm | Type | Receives |
|---|---|---|
| GA-STOMA | Experimental | Behavioral: Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)A web-based intervention will be provided in addition to routine surgical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients Age 65+ years
- clinicians age 18+ years
- Patients undergoing fecal ostomy surgery and their clinicians
Key exclusion criteria (1 listed)
- cognitive impairment not allowing completion of consent procedures based on the teach-back method.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)The web-based intervention provides patients with a survey and tailored content with the purpose of better supporting recovery and adaptation after surgery with a fecal ostomy | Behavioural | GA-STOMA |
Primary outcome
Acceptability
Time frame: 6 weeks
Interviews will be performed to assess the ability to use the intervention, complete questions, obtain management recommendations and complete management recommendations.
1 secondary outcome
Client Satisfaction questionnaire
Time frame: 6 weeks after surgery date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christy Cauley, MD, MPH principal investigator
MassGeneral Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA) in people with Ostomy - Ileostomy or Colostomy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christy Cauley, MD, MPH (617-726-8129, ccauley@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.