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AH-HA EHR Tool for Heart Health in Cancer Survivors (AH-HA Trial)
N/A
Waitlist Available
Led By Kathryn Weaver, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years.
Survivors must have no evidence of disease at the time of last medical visit for all cancers, except non-melanoma skin disease.
Must not have
Survivors will be excluded if they have a history of cancer recurrence for any cancer other than non-melanoma skin disease.
Survivor does not speak English or Spanish.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial is looking at the effects of a tool that uses electronic health records to help cancer survivors manage their cardiovascular health. The study will compare how well the tool works compared to usual care in terms of risk reduction and health promotion activities.
Who is the study for?
This trial is for adults over 18 who are cancer survivors (specifically of breast, prostate, colorectal, endometrial cancers or Hodgkin and non-Hodgkin lymphomas) with no current evidence of disease. They must understand English or Spanish, consent verbally to participate, be able to complete a follow-up in one year and have finished curative treatment at least 6 months ago.Check my eligibility
What is being tested?
The study tests an electronic health record tool called AH-HA designed to improve heart health discussions between patients and doctors. It will also look at whether the tool helps increase referrals to primary care/cardiology and promotes activities that reduce cardiovascular risk among cancer survivors.See study design
What are the potential side effects?
Since this intervention involves using a digital assessment tool rather than medication or medical procedures, traditional physical side effects are not expected. However, there may be indirect effects on healthcare practices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am cancer-free except for non-melanoma skin conditions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a cancer recurrence except for non-melanoma skin cancer.
Select...
I do not speak English or Spanish.
Select...
I am not on active surveillance for prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients reporting at least one non-ideal or missing CVH topic
Secondary outcome measures
CVH behaviors recorded in the past year
CVH factors recorded in the past year
Completed visits with primary care providers and cardiology
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - AH-HA toolExperimental Treatment1 Intervention
With assistance from the study team, the clinic will implement the AH-HA tool in the clinics' EPIC EHR. Providers at the intervention sites will be trained to use the tool during routine follow-up care with survivors. During a routine follow-up care appointment, the provider will use the AH-HA tool with enrolled patients.
Group II: Usual CareActive Control1 Intervention
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterOTHER
1,058 Previous Clinical Trials
1,054,478 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,287 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,756 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a cancer recurrence except for non-melanoma skin cancer.I am 18 years old or older.You are currently participating in another study that focuses on improving heart health through factors like blood pressure, smoking, diet, and physical activity.I have a cancer follow-up visit within 30 days with an AH-HA trained provider.I do not speak English or Spanish.It's been over 6 months since my last cancer treatment, but I may still be on hormone therapy.I am not on active surveillance for prostate cancer.I am cancer-free except for non-melanoma skin conditions.I understand the study and agree to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention - AH-HA tool
- Group 2: Usual Care
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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