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Shared Decision-making and Colorectal Cancer Screening

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRC decision aid pamphlet
Home Safety Pamphlet
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring decision aid, screening, older adults, low health literacy

Eligibility Criteria

75 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Be between the ages of 75 and 85 years
  • Must be low health literacy (LHL), determined by participants' response to the validated LHL question, "How confident are you filling out medical forms by yourself?" with a response of, "somewhat to not at all confident."39-43
  • Have an educational level at community college or less

Exclusion Criteria:

  • Patients who do not have the capacity to participate
  • Patients with dementia
  • Patients with a history of invasive/non-invasive colorectal cancer.
  • Patients older than 85 years since guidelines recommend against CRC screening in this age range.

Sites / Locations

  • University of Pennsylvania Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CRC DA

Home Safety Pamphlet

Arm Description

Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.

Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.

Outcomes

Primary Outcome Measures

Change in CRC Screening Intentions
Number of participants who indicate their intentions to be screened or not be screened for CRC, Change from baseline to immediately after the intervention

Secondary Outcome Measures

Change in Knowledge
Number of participants who correctly answer 15 true/false knowledge questions developed the investigators, about the harms and benefits of CRC screening, Change from baseline to immediately after the intervention
Perceptions of Shared Decision-making Role
Number of participants who answer the question that participants want to make a CRC screening decision with their physician, from 5 decision-making role questions developed the investigators
Perceptions of the Length of the Decision Aid
Number of participants who indicate the decision aid is the right length, from a likert-scale question
Perceptions of the Clarity of the Decision Aid
Number of participants who indicate the decision aid is clear in the information presented, from a likert-scale question
Perceptions of the Balance of the Decision Aid
Number of participants who indicate the decision aid present information that is not slanted towards CRC screening or slanted away from CRC screening, from a likert-scale question
Feelings of anxiety when reading the decision aid
Number of participants who felt anxious after reading the decision aid, from a likert-scale question
Feelings of usefulness of the decision aid
Number of participants who indicate recommending the decision aid to a friend, from a likert-scale question

Full Information

First Posted
January 22, 2021
Last Updated
July 20, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04748380
Brief Title
Shared Decision-making and Colorectal Cancer Screening
Official Title
Shared Decision-making and Colorectal Cancer Screening Behaviors Among Older Adults With Low Health Literacy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

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
Conduct a feasibility pilot RCT of a newly developed colorectal cancer screening (CRC) decision aid (DA) including 66 LHL adults 76-85 years recruited from community health centers. Hypotheses: Patients in the intervention group will be more likely to change their intentions to be screened with fewer patients with <10 year LE and/or those with >10 year LE and no risk factors intending to be screened and more with >10 year LE and risk factors for CRC and/or those who have never been screened intending to be screened (primary outcome). The secondary outcomes are that the patients in the intervention group will have 1. increased knowledge of CRC screening options and the benefits and risks of these options; 2. increased SDM engagement; and 3. find the DA acceptable. Investigators also anticipate that at least 50% of eligible participants will choose to participate in the study.
Detailed Description
Investigators will recruit and survey 66 adults (to reach a goal of 60 with complete data), 75-85 years with low health literacy LHL (30 per arm) over 24 months to learn the effects of the newly developed CRC DA pamphlet on older adult's screening intentions, knowledge of options and the benefits and harms, and SDM from community health centers. Investigators collect baseline data over the phone prior to the visit. Patients who are eligible and willing to participate will come to a regularly scheduled visit with their primary care physician (PCP) early to answer the pretest questions. Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule. The home safety information is 2 pages, and was designed by AGS Health in Aging Foundation. It has been used successfully in prior studies of DAs as a control intervention. Investigators chose this pamphlet for the control arm because it is written at <7th grade reading level and reading about home safety should not affect screening decisions. Providing the control group the home safety pamphlet to read reduces response bias since it helps keep participants blinded to the intervention of interest and compensates for the time and attention required by the intervention group to read the DA. At the visit, participants will review the DA or the home safety pamphlet. The revised CRC DA pamphlet is expected to take 5-10 minutes to read as well as the home safety pamphlet. After completing the pre-survey questionnaire before the visit the patient will have their PCP visit. The post-test will be asked after the PCP visit in person or over the phone (depending on the participant's preference, access to a phone, and ability to stay after their appointment for enough time to complete the post-visit questionnaire). Investigators will conduct a chart review at 6 months to see if a CRC screening discussion occurred and the outcome (i.e., qualitative trends in use of CRC screening). Investigators will also call each patient at 6 months to ask about their CRC screening intentions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
decision aid, screening, older adults, low health literacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule.
Masking
Participant
Masking Description
Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet and 30 will be randomized to receive the home safety information at the visit in case they cancel their appointment and reschedule.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRC DA
Arm Type
Experimental
Arm Description
Stratifying by sex, 30 participants will be randomized to receive the CRC DA pamphlet.
Arm Title
Home Safety Pamphlet
Arm Type
Other
Arm Description
Stratifying by sex, 30 will be randomized to receive the home safety information at the visit.
Intervention Type
Other
Intervention Name(s)
CRC decision aid pamphlet
Intervention Description
A newly developed 8-10 page decision aid pamphlet that discusses:1. Information on CRC; 2. Information about risk and benefits including the 10-year lag-time to benefitting from CRC screening; 3. Information to help patients evaluate CRC screening options (colonoscopy or stool testing); 4. Possible outcomes relevant to LE and health status. In addition, there will be a values clarification exercise
Intervention Type
Other
Intervention Name(s)
Home Safety Pamphlet
Intervention Description
The home safety information pamphlet is a 2-page fact sheet on home safety tips for older adults, and was designed by the AGS Health in Aging Foundation. It includes information in seven areas to help older adults stay safe in their homes. Areas include but are not limited to fall prevention and safety proofing homes. It has been used successfully in prior studies of DAs as a control intervention
Primary Outcome Measure Information:
Title
Change in CRC Screening Intentions
Description
Number of participants who indicate their intentions to be screened or not be screened for CRC, Change from baseline to immediately after the intervention
Time Frame
Baseline, pre-intervention to immediately after the intervention
Secondary Outcome Measure Information:
Title
Change in Knowledge
Description
Number of participants who correctly answer 15 true/false knowledge questions developed the investigators, about the harms and benefits of CRC screening, Change from baseline to immediately after the intervention
Time Frame
Baseline, pre-intervention to immediately after the intervention
Title
Perceptions of Shared Decision-making Role
Description
Number of participants who answer the question that participants want to make a CRC screening decision with their physician, from 5 decision-making role questions developed the investigators
Time Frame
immediately after the intervention
Title
Perceptions of the Length of the Decision Aid
Description
Number of participants who indicate the decision aid is the right length, from a likert-scale question
Time Frame
immediately after the intervention
Title
Perceptions of the Clarity of the Decision Aid
Description
Number of participants who indicate the decision aid is clear in the information presented, from a likert-scale question
Time Frame
immediately after the intervention
Title
Perceptions of the Balance of the Decision Aid
Description
Number of participants who indicate the decision aid present information that is not slanted towards CRC screening or slanted away from CRC screening, from a likert-scale question
Time Frame
immediately after the intervention
Title
Feelings of anxiety when reading the decision aid
Description
Number of participants who felt anxious after reading the decision aid, from a likert-scale question
Time Frame
immediately after the intervention
Title
Feelings of usefulness of the decision aid
Description
Number of participants who indicate recommending the decision aid to a friend, from a likert-scale question
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be between the ages of 75 and 85 years Must be low health literacy (LHL), determined by participants' response to the validated LHL question, "How confident are you filling out medical forms by yourself?" with a response of, "somewhat to not at all confident."39-43 Have an educational level at community college or less Exclusion Criteria: Patients who do not have the capacity to participate Patients with dementia Patients with a history of invasive/non-invasive colorectal cancer. Patients older than 85 years since guidelines recommend against CRC screening in this age range.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Cadet, PhD, LICSW, MPH
Phone
215-898-5501
Email
cadet@upenn.edu
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual participant data available to other researchers.

Learn more about this trial

Shared Decision-making and Colorectal Cancer Screening

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