Colorectal CancerNCT03310892
Tailored Messaging for CRC Screening
A study testing Generic message and Tailored message in people with Colorectal Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a randomized controlled trial to to determine whether direct, tailored messaging to patients prior to scheduling colonoscopy will increase patient adherence to provider recommendation for screening colonoscopy. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Generic message and Tailored message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment
- 50-75 years of age
- Due for CRC screening or surveillance (defined as no evidence of: colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, stool DNA test or Cologuard in the last 3 years)
Who cannot join
- Age <50 or >75
- Pregnant woman
- Evidence of prior colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, fecal DNA test or Cologuard in the last 3 years
- History of colorectal cancer
- History of inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
- History of colon surgery or resection
Show all 13Show fewer
- History of symptoms concerning for colorectal cancer, such as lower GI bleeding, within the past 6 months
- Family history of a hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC)
- Current serious medical condition with estimated life expectancy of less than 6 months, such as incurable cancer, end-stage congestive heart failure, decompensated cirrhosis, end stage renal disease, etc.
- Dementia
- Does not speak English
- No telephone number listed in electronic medical record
- Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: Patient-directed Messaging to Increase Colorectal Cancer Screening
This is a randomized controlled trial to to determine whether direct, tailored messaging to patients prior to scheduling colonoscopy will increase patient adherence to provider recommendation for screening colonoscopy.
Read the detailed description
The proposed study is a prospective, randomized trial. All eligible subjects (patients identified to be contacted to schedule screening colonoscopy) will be randomized to one of three study arms: usual scheduling process (control), a generic message arm, or a tailored message arm. Patients in the "tailored message" arm will receive a telephone call and be asked a series of questions that will be used to assign patients to one of four messaging cohorts. After these questions have been answered, the patient will then receive a tailored message corresponding to his or her respective messaging cohort, encouraging them to schedule a colonoscopy with a directed script. In the "generic message" arm, patients will receive a telephone call and be asked to answer the same series of questions as the "tailored message" group, then receive a single, standard script encouraging them to schedule a colonoscopy.
- Conditions
- Colorectal Cancer
- Being tested
- Generic message, Tailored message
- Keywords
- Colorectal cancer screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic messageBehavioural
Generic message
Tailored messageBehavioural
Tailored message
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants in this arm will Usual scheduling process without any intervention |
| Generic Message | Experimental | Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the study team member will ask the participant a series of 7 questions then receive a "generic" message encouraging colonoscopy scheduling. Receives: Behavioral: Generic message |
| Tailored Message | Experimental | Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the participant will answer a series of 7 questions then receive a "tailored" message encouraging colonoscopy scheduling, which will be determined by their responses to the preceding questions. Receives: Behavioral: Tailored message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy completion rate
The ratio of the number of participants who complete a colonoscopy to the total number of enrolled participants
Measured: 120 days
Secondary outcomes (1)
Colonoscopy scheduling rate
The ratio of the number of participants who schedule a colonoscopy to the total number of enrolled participants
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start9 Oct 2017
- Primary completion30 Jun 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael L Kochman, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310892
- Sponsor's protocol ID
- 827866
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2017
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oyalowo A, Forde KA, Lamanna A, Kochman ML. Effect of Patient-Directed Messaging on Colorectal Cancer Screening: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e224529. doi: 10.1001/jamanetworkopen.2022.4529.
PubMed 35357457
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-directed Messaging to Increase Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT03310892
- Acronym / sponsor ID
- 827866
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to to determine whether direct, tailored messaging to patients prior to scheduling colonoscopy will increase patient adherence to provider recommendation for screening colonoscopy.
Detailed description
The proposed study is a prospective, randomized trial. All eligible subjects (patients identified to be contacted to schedule screening colonoscopy) will be randomized to one of three study arms: usual scheduling process (control), a generic message arm, or a tailored message arm. Patients in the "tailored message" arm will receive a telephone call and be asked a series of questions that will be used to assign patients to one of four messaging cohorts. After these questions have been answered, the patient will then receive a tailored message corresponding to his or her respective messaging cohort, encouraging them to schedule a colonoscopy with a directed script. In the "generic message" arm, patients will receive a telephone call and be asked to answer the same series of questions as the "tailored message" group, then receive a single, standard script encouraging them to schedule a colonoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants in this arm will Usual scheduling process without any intervention |
| Generic Message | Experimental | Behavioral: Generic messageParticipants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the study team member will ask the participant a series of 7 questions then receive a "generic" message encouraging colonoscopy scheduling. |
| Tailored Message | Experimental | Behavioral: Tailored messageParticipants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the participant will answer a series of 7 questions then receive a "tailored" message encouraging colonoscopy scheduling, which will be determined by their responses to the preceding questions. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment
- 50-75 years of age
- Due for CRC screening or surveillance (defined as no evidence of: colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, stool DNA test or Cologuard in the last 3 years)
Key exclusion criteria (13 listed)
- Age <50 or >75
- Pregnant woman
- Evidence of prior colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, fecal DNA test or Cologuard in the last 3 years
- History of colorectal cancer
- History of inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generic messageGeneric message | Behavioural | Generic Message |
| Tailored messageTailored message | Behavioural | Tailored Message |
Primary outcome
Colonoscopy completion rate
Time frame: 120 days
The ratio of the number of participants who complete a colonoscopy to the total number of enrolled participants
1 secondary outcome
Colonoscopy scheduling rate
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 35357457Oyalowo A, Forde KA, Lamanna A, Kochman ML. Effect of Patient-Directed Messaging on Colorectal Cancer Screening: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e224529. doi: 10.1001/jamanetworkopen.2022.4529.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Kochman, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generic message and Tailored message in people with Colorectal Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonoscopy completion rate (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.