Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Recall of Cancer Screening and Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014295
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Other: Accessing personal medical records online via online portals Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient Recall of Cancer Screening and Diagnosis
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.
Other: Accessing personal medical records online via online portals
The participants will receive details on accessing personal medical records online via online portals, for each of the major hospital systems




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014295


Contacts
Layout table for location contacts
Contact: Cheryl Thompson, PhD 216-368-3956 clw8@case.edu

Locations
Layout table for location information
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Cheryl Thompson, PhD Case Comprehensive Cancer Center
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05014295    
Other Study ID Numbers: CASE1Z21
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases