- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03747276
Can Electronic Information Kiosks Enhance Patient Accrual for Cancer Clinical Trials? A Pilot and Feasibility Study
The proposed study will include patients with non-haematologic cancer. Eligible patients will be invited to consent for participation in our study using standard demographic data collection forms and patient satisfaction questionnaires.
Cancer patients interested in learning more about clinical trials would be invited to go to the kiosk. A summer student approved and hired according to London Health Sciences Centre LHSC/Lawson criteria will be available from 0900-1630 daily for general assistance. If the student is overwhelmed by questions or numbers of patients, the Research Navigator or designate would be called to assist.
An information kiosk will be placed at the patient library on the ground floor of the LRCP. This kiosk will be outfitted with a computer and signage briefly outlining the title and purpose of the kiosk. Cancer patients interested in learning more about clinical trials would be invited to participate in our study by signing a consent form allowing the Research Navigator to contact them if they expressed interest in knowing more about a clinical trial.
Study Overview
Detailed Description
The proposed study will include patients with non-haematologic cancer. Eligible patients will be invited to consent for participation in our study using standard demographic data collection forms and patient satisfaction questionnaires.
Cancer disease site teams (DSTs) were asked to prioritize trials that open from May 1 to Sept.30, 2018 and likely to accrue three patients over six months for major accruing tumour sites (lung, breast, GI, GU, melanoma and symptom control/supportive care/multi-site such as oligometastatic) and one patient over six months for other sites.
Patients are made aware of the kiosk via advertising in the facility including a card given at registration each day outlining the existence, location and purpose of the kiosk. The location will be marked by visual cues (banner and balloons). Cancer patients interested in learning more about clinical trials would be invited to go to the kiosk. A summer student approved and hired according to LHSC/Lawson criteria will be available from 0900-1630 daily from July 3-Aug 31 for general assistance. If the student is overwhelmed by questions or numbers of patients, the Research Navigator or designate would be called to assist.
An information kiosk will be placed at the patient library on the ground floor of the LRCP. This kiosk will be outfitted with a computer and signage briefly outlining the title and purpose of the kiosk. Cancer patients interested in learning more about clinical trials would be invited to participate in our study by signing a consent form allowing the Research Navigator to contact them if they expressed interest in knowing more about a clinical trial. They would still be able to read a lay online or printed paper document giving them background information on clinical trials (i.e. what is a clinical trial?) whether they consented or not. To save on resources, the pilot will utilize general information available to the public from the Stanford Cancer Institute Clinical Trials website at http://med.stanford.edu/cancer/trials.html and a Canadian website http://itstartswithme.ca/why-participate/ . Information specific to clinical trials at London Regional Cancer Program (LRCP) will be made available by linking to an internal resource. Patients will be asked if they would be interested in seeing brief summaries of selected clinical trials currently available at the LRCP. They would then be asked to review a list of possible trials they may be eligible for based on their cancer diagnosis. Patients will have the option to click on each of the applicable trials to obtain more information including: trial title, NCT number, a lay description, why the study is important, principal investigator name, and a short list of eligibility criteria. Additionally, patients have the option to send any trial information they might be interested in to their home their email address or obtain a paper copy of the information.
Finally, at the kiosk patients who signed a consent, would have the option to submit electronically their first/last name and DOB in order to grant permission for a member of the Clinical Research Unit (CRU) staff, the Research Navigator, to review their request for further clinical trial information, contact them with potential options and contact their oncologist(s) to discuss their potential enrollment in a specific trial. This consent, patient name and PIN numbers would then be emailed to the CRU. Alternatively, they could fill this out on a paper form that would be dropped into a secure mailbox at the kiosk that would be collected at the end of each day. The information would be logged on a secure electronic database by HM and the paper documents except for consent destroyed (or kept in a secure area). The Research Navigator would contact the patient by phone to provide further details of the trial(s) of interest and to determine eligibility. If the patient is interested and eligible, an indication of the clinical trial of interest would be added to the scheduling list beside the patient's name.
After a two week run in phase, accrual, logistical and communications issues will be reviewed to ensure the kiosk project is functioning efficiently and to review patient satisfaction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
-
London, Ontario, Canada, N6A 4G5
- London Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients diagnosed with a solid tumour cancer (including breast, central nervous system, gynecologic, gastrointestinal, genitourinary, head and neck, liver, melanoma, neuroendocrine, sarcoma, thoracic, thyroid).
- Patients able to provide independent informed consent.
Exclusion Criteria:
- Patients less than 18 years of age
- Patients diagnosed with haematologic malignancy unless there is a co-existing solid tumour cancer
- Inability to provide informed consent
- Inability to read and comprehend written English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Clinical Trial Kiosk
|
Kiosk will consist of a patient facilitator and a computer with access to general information about clinical trials and information specific to active clinical trials at the facility.
Patients will be made aware of the kiosk via a large banner visible in the clinic above the kiosk.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in accrual rate
Time Frame: 4 months (A two month rate of accrual (May-June, 2018) will be determined before opening the kiosk. A second two month accrual period (August-September) will be used to assess the change in trial accrual.
|
Our primary objective is to quantify the clinical trial accrual rates in a subset of trials that are selected as priority trials and are open both two months before and three months after implementation of the clinical trial information kiosk.
Accrual rates before and after implementation will be compared.
|
4 months (A two month rate of accrual (May-June, 2018) will be determined before opening the kiosk. A second two month accrual period (August-September) will be used to assess the change in trial accrual.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients requesting research navigator contact
Time Frame: 3 months
|
1. To determine the proportion of patients who accessed the kiosk provided information so that they could be contacted by the Research Navigator.
|
3 months
|
Proportion of patients contacted eligible for clinical trial
Time Frame: 3 months
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2. To determine what proportion of patients who were contacted the research navigator were eligible to participate in a clinical trial.
|
3 months
|
Proportion of eligible patients participating in clinical trial
Time Frame: 5 months
|
To determine what proportion of patients eligible for a clinical trial actually participated.
|
5 months
|
Satisfaction with kiosk
Time Frame: 2 months
|
To evaluate patient satisfaction with the clinical trial information kiosk using a Likert scale.
|
2 months
|
Proportion of patients accessing kiosk
Time Frame: 2 months
|
To determine the number of individuals who interacted with the information kiosk compared to total number of cancer patients seen in clinic when the kiosk is open.
|
2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics
Time Frame: 2 months
|
Demographic correlations of patients seeking additional information.
This will include age, sex, urban/rural status obtained from electronic health records.
Patients will also be asked to voluntarily provide information on income, occupational status and whether they had previously been approached about a cancer clinical trial.
|
2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Information Kiosk
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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