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Can Electronic Information Kiosks Enhance Patient Accrual for Cancer Clinical Trials? A Pilot and Feasibility Study

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ClinicalTrials.gov Identifier: NCT03747276
Recruitment Status : Unknown
Verified November 2018 by Lawson Health Research Institute.
Recruitment status was:  Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE June 13, 2018
First Posted Date  ICMJE November 20, 2018
Last Update Posted Date November 20, 2018
Actual Study Start Date  ICMJE July 19, 2018
Actual Primary Completion Date September 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • 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.
  • Proportion of patients contacted eligible for clinical trial [ Time Frame: 3 months ]
    2. To determine what proportion of patients who were contacted the research navigator were eligible to participate in a clinical trial.
  • 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.
  • Satisfaction with kiosk [ Time Frame: 2 months ]
    To evaluate patient satisfaction with the clinical trial information kiosk using a Likert scale.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 16, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Can Electronic Information Kiosks Enhance Patient Accrual for Cancer Clinical Trials? A Pilot and Feasibility Study
Official Title  ICMJE Can Electronic Information Kiosks Enhance Patient Accrual for Cancer Clinical Trials? A Pilot and Feasibility Study
Brief Summary

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 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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Malignant Neoplasm
Intervention  ICMJE 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.
Study Arms  ICMJE Clinical Trial Kiosk
Intervention: Other: Clinical Trial Kiosk
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 16, 2018)
560
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 18, 2018
Actual Primary Completion Date September 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03747276
Other Study ID Numbers  ICMJE Information Kiosk
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Present at meetings and publish in peer reviewed journal
Supporting Materials: Study Protocol
Time Frame: One year
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE London Health Sciences Centre
Investigators  ICMJE Not Provided
PRS Account Lawson Health Research Institute
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP