- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05014295
Patient Recall of Cancer Screening and Diagnosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized controlled trial of an intervention to encourage use of online medical records for filling out a cancer screening, diagnosis and treatment questionnaire. Participants will be asked to self-report on cancer screening and treatment. They will then be asked the same questions again a week later.
The control group will have had one week to reflect on the questions, and investigators anticipate some influence of this on responses. The intervention group will be prompted about accessing their medical records from the major local health systems online, with links to directions provided by each hospital system. They will then be asked to fill out the same questionnaire.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ohio
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Cleveland, Ohio, United States, 44106
- Case Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosed with breast or prostate cancer within the last 10 years
- have access to the internet with a working email address
- reside in Northeast Ohio
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Survey questions at baseline and at one week.
The control group will have had one week to reflect on the questions, and investigators anticipate some influence of this on responses.
|
|
|
Active Comparator: Intervention Group
The intervention group will be prompted about accessing their medical records from the major local health systems online, with links to directions provided by each hospital system.
They will then be asked to fill out the same questionnaire.
|
The participants will receive details on accessing personal medical records online via online portals, for each of the major hospital systems
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completeness of survey
Time Frame: at 1 week (after second survey completed)
|
Completeness: For each survey, for each participant, investigators will count the number of "don't know" response rates.
From this, investigators will calculate the percent completeness of the survey.
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at 1 week (after second survey completed)
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Accuracy of survey
Time Frame: at 1 week (after second survey completed)
|
Investigators will assess the inter-rater reliability between the first and second survey by calculating a Cohen's Kappa coefficient.
Although not a perfect assumption, investigators will use the second survey as the reference.
Number of changed answers on an individual level will be calculated, representing improved accuracy.
Investigators do not anticipate many changes, and, again, this will not be normally distributed.
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at 1 week (after second survey completed)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cheryl Thompson, PhD, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE1Z21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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