Patient Recall of Cancer Screening and Diagnosis
Primary Purpose
Breast Cancer, Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accessing personal medical records online via online portals
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
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:
-
Sites / Locations
- Case Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
Intervention Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Completeness of survey
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.
Accuracy of survey
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05014295
First Posted
August 13, 2021
Last Updated
October 4, 2023
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05014295
Brief Title
Patient Recall of Cancer Screening and Diagnosis
Official Title
Patient Recall of Cancer Screening and Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to try to better understand how much information relating to cancer screening and diagnoses that people can recall on their own and to better understand how to help people get better information. In this study, investigators will see if giving time or other resources help individuals remember more and more accurate details about their cancer screening and care.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Accessing personal medical records online via online portals
Intervention Description
The participants will receive details on accessing personal medical records online via online portals, for each of the major hospital systems
Primary Outcome Measure Information:
Title
Completeness of survey
Description
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.
Time Frame
at 1 week (after second survey completed)
Title
Accuracy of survey
Description
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.
Time Frame
at 1 week (after second survey completed)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl Thompson, PhD
Phone
216-368-3956
Email
clw8@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Thompson, PhD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Recall of Cancer Screening and Diagnosis
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