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Health Message Framing to Improve Uptake of Bowel Cancer Screening

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Text Message
Sponsored by
National Heatlh Service Ayrshire and Arran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Behavioural Economics

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Over 55
  • Not yet returned a bowel cancer screening sample
  • No diagnosis of bowel cancer

Exclusion Criteria:

  • Under 55
  • Have already completed bowel cancer screening
  • Diagnosed with bowel cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Intervention 1

    Intervention 2

    Intervention 3

    Arm Description

    Text message (SMS Message)

    Text message (SMS Message)

    no intervention

    Outcomes

    Primary Outcome Measures

    Number of participants taking part in the Scottish national bowel cancer screening programme
    Number of participants taking part in the Scottish national bowel cancer screening programme represented as a patient having submitted a faecal occult blood test.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2018
    Last Updated
    March 27, 2018
    Sponsor
    National Heatlh Service Ayrshire and Arran
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03487523
    Brief Title
    Health Message Framing to Improve Uptake of Bowel Cancer Screening
    Official Title
    Health Message Framing to Improve Uptake of Bowel Cancer Screening
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 21, 2018 (Anticipated)
    Primary Completion Date
    December 21, 2018 (Anticipated)
    Study Completion Date
    January 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Heatlh Service Ayrshire and Arran

    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 objective of this research is to investigate whether a text message (SMS message) prompting participation in the UK national bowel cancer screening programme improves uptake for those who have not responded to the test. The secondary objective is to investigate whether the framing/phrasing of the text message improves participation , whether by stating the benefits of uptake or alternatively by stating the costs of non-uptake.
    Detailed Description
    A national register exists for GP practices to identify which patients of theirs have or have not participated in a national bowel cancer screening programme. A sample of 1600 patients belonging to a particular practice in Scotland aged between 50 and 74 have been identified as having received the test kit but have not responded to it. These individuals have also previously consented to being contacted by the practice via phone text/SMS message for reminders. The sample will be randomised into three equally populated groups: One group will act as the control arm and will receive no text message. One group will receive a text message which encourages participation in the screening programme and provides information on the cost of not participating (negative frame) - "If you do not take part in screening then you increase the risk of having an undiagnosed tumor." One group will receive a text message which encourages participation in the screening programme and provides information on the benefit of participating (positive frame) - "If you take part in screening then you decrease the risk of having an undiagnosed tumor." Both text messages will include a weblink which will direct individuals receiving the text to find more information and also with instructions on how to order another kit should they have misplaced the kit that was mailed out to them. The observation period will last 6 months and patients receiving the text will receive 3 texts in total. One at the start of the 6 months and another every two months after that. These messages will not change or alternate, that is the negatively framed group will receive the same text once every 2 months on 3 occasions in total and vice versa. Other studies have used shorter intervals between text messages to encourage change, although 6 months to 1 year is a standard amount of time overall. The researchers feel that while more regular messages may be more likely prompt behaviour there is also a risk of over-burdening the patient with reminders, as such 3 texts over 6 months was decided upon as a reasonable frequency. At the end of the 6 months data on uptake of screening for those 1600 patients during that time will be extracted by the practice clinician, matched with patient characteristics (e,g, age, sex) and anonymised so that patients cannot be identified. This will then be sent to the health economist to analyse the data and test the hypotheses above. Regression analysis will be used to see whether a differential pattern of uptake exists between groups receiving and not receiving the text message. Once analysed the results will be fed back to the practice in order to help inform future reminders and will also be drafted into a paper to be submitted for peer-review.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Behavioural Economics

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    The study will be a cross sectional randomised controlled trial
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention 1
    Arm Type
    Active Comparator
    Arm Description
    Text message (SMS Message)
    Arm Title
    Intervention 2
    Arm Type
    Active Comparator
    Arm Description
    Text message (SMS Message)
    Arm Title
    Intervention 3
    Arm Type
    No Intervention
    Arm Description
    no intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Text Message
    Intervention Description
    As already stated
    Primary Outcome Measure Information:
    Title
    Number of participants taking part in the Scottish national bowel cancer screening programme
    Description
    Number of participants taking part in the Scottish national bowel cancer screening programme represented as a patient having submitted a faecal occult blood test.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Over 55 Not yet returned a bowel cancer screening sample No diagnosis of bowel cancer Exclusion Criteria: Under 55 Have already completed bowel cancer screening Diagnosed with bowel cancer
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patrick McGuire
    Phone
    +447596096536
    Email
    paddymcguire7@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick McGuire
    Organizational Affiliation
    Dr
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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