Evaluating the Impact of the McMaster Optimal Aging Portal on Cancer Prevention Behaviours in Underserved Populations

February 19, 2020 updated by: McMaster University

Evaluating the Impact of the McMaster Optimal Aging Portal on Knowledge, Behavioural Intentions and Health Behaviours Related to Cancer Risk in Underserved Populations.

The goal of the McMaster Optimal Aging Portal is to be a trustworthy source for health information. The Portal team can see (through measuring analytics of website use) that thousands of people are using the Portal and the knowledge-sharing strategies in place (email alerts, Twitter and Facebook), with many more users added each month. Previous studies have measured the quality and trustworthiness of health information available online; others have studied the numbers and populations who use different types of information and how easy it is to use and understand. This study builds on that knowledge to find out: if easy-to-understand evidence-based messages reach members of the public, do these messages change what people know and think to do to stay healthy (in this case, what they know and think to do to lower their risk of cancer)?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Half of cancers are preventable through lifestyle modification such as smoking cessation, healthy eating, increasing physical activity and reducing alcohol intake; however, few Canadians engage in behaviours that are in line with cancer prevention guidelines. This may be in part due to lack of access to evidence-based information and the mixed messages on effective cancer prevention strategies that are propagated in the popular media.

The McMaster Optimal Aging Portal (the Portal) is a knowledge translation (KT) tool launched in 2014 to increase public access to trustworthy health information. Citizen-friendly content (blog posts, evidence summaries, web resource ratings) provide easy-to-read 'bottom line' messages appropriate for all audiences. Investigators would now like to know if and how KT strategies used to disseminate citizen-targeted information on cancer prevention impact knowledge, behavioural intentions and health behaviours of Canadian adults.

This study will use a sequential mixed-methods design consisting of a two-arm randomized controlled trial (RCT) and a qualitative process study to explore RCT findings in depth. This formative approach will allow for a deeper analysis of the outcomes of interest (knowledge, intentions and behaviours), and the KT process. Following baseline data collection, eligible participants will be randomized to a 12-week intervention or control group.

During the intervention, participants will have access to the Portal, be invited to follow a Twitter and Facebook feed, and receive tailored weekly email alerts including blog posts and evidence summaries on cancer prevention. Control group participants will have access the Portal in a 'self-serve' fashion, but will not receive KT strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
549

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8P0A1
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English speaking

Exclusion Criteria:

  • Previous cancer diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Tailored knowledge translation
During the 12-week intervention, intervention group participants will have access to the Portal and will receive targeted weekly email alerts including blog posts and evidence summaries relevant to cancer prevention and be invited to follow a Twitter and Facebook feed; a unique hashtag will be created to identify and collate relevant cancer prevention information.
Behavioral: Tailored knowledge translation
Tailored knowledge translation strategies specific to evidence-based cancer prevention recommendations
NO_INTERVENTION: Control
Participants in the control group will have access to the Portal in a 'self-serve' fashion. These participants will be able to browse the Portal, subscribe to email alerts, follow social media, etc. but will not receive the tailored intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Website engagement
Time Frame: 12 weeks
Number of clicks
12 weeks
Email engagement
Time Frame: 12 weeks
Number of clicks
12 weeks
Social media engagement
Time Frame: 12 weeks
Number of clicks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge questionnaire
Time Frame: 12 weeks, 3-months post-intervention
Participants knowledge of cancer prevention recommendations and guidelines
12 weeks, 3-months post-intervention
Beliefs questionnaire
Time Frame: 12 weeks, 3-months post-intervention
Participants beliefs about the importance of lifestyle in prevention cancer
12 weeks, 3-months post-intervention
Intentions questionnaire
Time Frame: 12 weeks, 3-months post-intervention
Participants intentions to engage in lifestyle behaviours in line with cancer prevention guidelines
12 weeks, 3-months post-intervention
Godin leisure time exercise questionnaire
Time Frame: 12 weeks, 3 months post-intervention
Physical activity
12 weeks, 3 months post-intervention
Dietary Screener Questionnaire
Time Frame: 12 weeks, 3 months post-intervention
Dietary intake
12 weeks, 3 months post-intervention
Tobacco Questions for Surveys, World Health Organization
Time Frame: 12 weeks, 3 months post-intervention
Current smoking behaviour
12 weeks, 3 months post-intervention
Seven-day recall alcohol
Time Frame: 12 weeks, 3 months post-intervention
Alcohol intake
12 weeks, 3 months post-intervention
Participant satisfaction
Time Frame: 12 weeks
Collected using qualitative interviews
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 316590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Locations

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