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Comprehensive Care Model for Cancer Survivors
N/A
Recruiting
Led By Hoda Badr
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 month follow-up
Awards & highlights
Study Summary
This trial is testing a care model for cancer survivors who also have other chronic conditions. The care model includes an oncology nurse navigator to help with communication and coordination of care between the oncologist and primary care provider. The trial will evaluate the impact of the care model on patient outcomes.
Who is the study for?
This trial is for adults over 18 with a new or recent diagnosis of early-stage breast, GI, or blood cancer who are undergoing standard treatments. They must also have chronic conditions like diabetes or hypertension, engage in unhealthy lifestyle behaviors, and be fluent in English or Spanish. Both their oncologist and primary care provider must agree to participate.Check my eligibility
What is being tested?
The OPTIMISE program is being tested against usual medical care. It includes an oncology nurse navigator to help coordinate between the patient's cancer doctor and primary care provider during treatment and survivorship planning that incorporates managing other health conditions.See study design
What are the potential side effects?
Since OPTIMISE focuses on improving healthcare delivery rather than testing a drug, it doesn't have typical medication side effects. However, changes in healthcare management may affect patients' experiences during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Instrument to measure Self-Management (IMSM)
Patient Activation Measure (PAM)
Secondary outcome measures
Function Assessment of Cancer Therapy (FACT-G)
Supportive Care Needs Survey (SCNS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OPTIMISEExperimental Treatment1 Intervention
OPTIMISE components to facilitate Patient self-management support are: 1) a bilingual oncology nurse navigator (ONN) and care coordination; 2) distress screening; 3) tailored comorbidity self-management action planning, 4) tailored survivorship action planning, and 5) surveillance reminders and follow-up. OPTIMISE components to facilitate provider decision support are: 1) when the initial referral is made, the ONN will send the PCP treatment plan summary (based on the ASCO treatment plan template) and standardized fact sheets on treatment toxicities; 2) throughout treatment, there will be bi-directional and structured communication between oncologist and PCP facilitated by the ONN; 3) The ONN will send the SCP to the PCP describing surveillance guidelines and summary of late effects. Finally, OPTIMISE will adopt a risk-stratified shared care model of post-treatment survivorship care.
Group II: Usual Medical Care (UMC)Active Control1 Intervention
UMC consists of standard oncologic care from point of diagnosis. Cancer patients with comorbidities are encouraged by their oncologist to follow up with their PCP regarding comorbidity management but no formal referral process is in place. At the end of cancer treatment (with standard, definitive therapies), patients meet with a nurse (Survivorship Nurse Practitioner, NP) to review the SCP, which is based on ASCO templates and populated from the EHR. The Survivorship NP also reviews therapies received, recommended surveillance, common late effects, and recommended lifestyle behaviors. Patients are given a printed copy of the SCP and are encouraged to share this information with their PCP. Cancer surveillance follows the traditional oncologist led model regardless of patient risk for recurrence.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OPTIMISE
2021
N/A
~160
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,001,912 Total Patients Enrolled
Hoda BadrPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand or make decisions due to cognitive issues.
Research Study Groups:
This trial has the following groups:- Group 1: OPTIMISE
- Group 2: Usual Medical Care (UMC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enlisted to this clinical trial?
"Affirmative. Clinicaltrials.gov attests to the fact that this clinical trial, which was initially published on April 1st 2022, is presently seeking participants. A total of 340 individuals are needed across one medical site."
Answered by AI
Are there still opportunities for participation in this clinical investigation?
"According to data hosted on clinicaltrials.gov, this research is actively seeking participants; it was first publicized on April 1st 2022 and modified most recently on May 16th of the same year."
Answered by AI
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