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New study aims to help cancer patients juggle multiple health issues

NCT ID NCT05323409

Disease control Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tests a program called OPTIMISE that helps cancer patients manage other chronic conditions like diabetes or high blood pressure during treatment. It assigns a nurse navigator to improve communication between cancer doctors and primary care doctors. About 340 patients with breast, gastrointestinal, or blood cancers will be randomly assigned to the program or usual care. The goal is to see if the program helps patients better manage their own health and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OPTIMISE shared care model (behavioral intervention)
What this could lead to
If effective, this model could improve how cancer patients with other chronic conditions manage their health and coordinate care between doctors.
What could go wrong
This is a relatively small, single-site study testing a behavioral intervention, so results may not apply broadly. The intervention may not significantly improve outcomes over usual care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * For patients: 1) new diagnosis or within three months of treatment initiation for early-stage breast (I-IIIB), GI (Stage I-III), or hematologic (Stage I-III) cancer 2) treatment with standard, definitive therapies (may include one or more modalities) 3) presence of one or more chronic comorbidities (e.g., diabetes, hypertension) and/or unhealthy lifestyle behaviors (e.g., overweight/obesity, current smoker, alcohol use) that require ongoing management during cancer treatment 4) age \>18 years 5) fluency in English or Spanish 6) ability to provide informed consent 7) assignment to a Harris Health oncologist and PCP who are willing to participate and will provide informed consent. For healthcare providers: 1) Person is an oncologist or PCP who treats patients with breast, GI, or hematologic malignancies at Harris Health BT/Smith Clinic Exclusion Criteria: * For Patients: Significant cognitive impairment or Lack of capacity to consent For Providers: None

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm digestive system cancer digestive system neoplasm hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Gastrointestinal cancer Hematologic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.