Survivor & Provider Activation for Colorectal Cancer Screening

(ASPIRES Trial)

Not currently recruiting at 4 trial locations
JK
MM
Overseen ByMelissa Marx, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best methods to encourage high-risk cancer survivors to undergo colorectal cancer screening. The trial includes three groups: one receives educational materials (Control), the second receives those materials plus interactive text messages and videos (Patient activation), and the third receives both of those along with information for their doctors (Primary care provider activation). Eligible participants are childhood cancer survivors who underwent specific types of radiation treatment and have never had colorectal cancer or a recent colonoscopy. Participants must also have access to a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance cancer screening practices for survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these methods are safe for encouraging colorectal cancer screening?

Research has shown that strategies to involve patients more in their healthcare are generally safe and well-received. Studies indicate that providing information and encouraging patients to request colorectal cancer screenings can increase screening rates without harm. This approach primarily uses text messages and educational materials, which are safe.

Similarly, activating primary care providers involves equipping doctors with resources to encourage patient screenings. Clinical guidelines support this method, which has been in use for over ten years. No evidence suggests negative effects from these strategies.

Both strategies emphasize education and communication, aiming to increase awareness and action without involving medical procedures or medications.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to boost colorectal cancer screening rates. Unlike standard approaches that often rely solely on educational materials, this trial tests patient activation through personalized text messages and resources, which could make the information more engaging and accessible. Additionally, the trial examines the impact of activating primary care providers with tailored materials about colorectal cancer risk, potentially enhancing their role in encouraging screening. These methods aim to increase screening uptake by making the process more interactive and involving both patients and their healthcare providers in new ways.

What evidence suggests that this trial's treatments could be effective for encouraging colorectal cancer screening?

Research shows that providing patients with information and encouraging them to request screenings can increase colorectal cancer screening rates. In this trial, participants in the Patient Activation group will receive interactive, tailored text messages with links to videos and resources to support their screening efforts. One study found that patients who received this kind of support were more likely to complete their screenings than those who did not.

Additionally, the trial includes a group where both patient and primary care provider (PCP) activation are involved. Studies have shown that patients whose doctors actively participate in their care are less likely to be diagnosed with late-stage colorectal cancer. In this trial, providing doctors with information about cancer risks is part of the PCP activation strategy to further encourage screenings. Both patient and doctor involvement appear promising in increasing screening rates among high-risk individuals.13678

Who Is on the Research Team?

The University of Chicago

Tara Henderson, MD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

KK

Karen Kim, MD, MS

Principal Investigator

The Pennsylvania State University

Are You a Good Fit for This Trial?

This trial is for high-risk cancer survivors without a family history of colorectal cancer, who were treated with certain types of radiation, and haven't had recent colorectal screenings. Participants must have a smartphone, be part of the Childhood Cancer Survivor Study, speak English, and live in the U.S.

Inclusion Criteria

Enrolled on the Childhood Cancer Survivor Study
My family has no history of colorectal cancer.
I have received radiation therapy to my abdomen, pelvis, spine, or whole body.
See 3 more

Exclusion Criteria

Do not reside in the United States

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data collected through patient and provider surveys and interviews

1-2 weeks

Intervention

Participants receive electronic resources and are assigned to control, patient activation, or patient activation + PCP activation groups

12 months

Follow-up

Participants are monitored for completion of colorectal cancer screening and other outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Control
  • Patient activation
  • Primary care provider activation
Trial Overview The ASPIRES study is testing different methods to motivate these survivors to undergo colorectal cancer screening. It compares no intervention (control) with strategies aimed at activating patients directly or through their primary care providers.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Group1: Control (C)Experimental Treatment1 Intervention
Group II: Group 3: Patient Activation and PCP Activation (PA + PCP)Experimental Treatment3 Interventions
Group III: Group 2: Patient Activation (PA)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials
275
Recruited
5,182,000+

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Penn State University

Collaborator

Trials
380
Recruited
131,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

St. Jude Children's Research Hospital

Collaborator

Trials
451
Recruited
5,326,000+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials
1,998
Recruited
602,000+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

Hunter College of City University of New York

Collaborator

Trials
43
Recruited
10,000+

The Hospital for Sick Children

Collaborator

Trials
724
Recruited
6,969,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

Published Research Related to This Trial

A project conducted at five primary care practices from 2010 to 2012 revealed that decision aids for colorectal cancer screening and back pain were distributed to only 9.3% and 10.7% of eligible patients, respectively, indicating a significant gap in their use despite their proven efficacy.
To improve the integration of decision aids into routine clinical care, the study suggests that substantial structural and cultural changes are needed, including ongoing incentives for use, enhanced physician training, and a team-based approach where all care team members are responsible for implementing these tools.
An effort to spread decision aids in five California primary care practices yielded low distribution, highlighting hurdles.Lin, GA., Halley, M., Rendle, KA., et al.[2022]

Citations

Patient Activation Increases Colorectal Cancer Screening ...The purpose of this study was to determine whether providing patients with screening information, activating them to ask for a screening test, and telephone ...
The Effect of a Shared Decision-Making Process on ...Before implementation, 35% of patients declined screening. Of patients undergoing screening, 76% used colonoscopy, 20% used FIT, and 4% used Mt- ...
Patient experience, satisfaction and shared decision ...This study aims to assess the experience, satisfaction and participation in decision-making of participants in a CRC screening programme.
Supporting Shared Decision Making between Clinicians ...This study compared two ways to help clinicians and older patients make colorectal cancer screening decisions.
Self-administered decision aids about colorectal cancer ...This systematic review showed a potential for self-administered DAs to support informed choice in colorectal cancer screening, especially by increasing ...
Shared Decision-making and Colorectal Cancer Screening ...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 ...
Using Basic and Personalized Decision Aids and Clinician ...In this study, the research team compared whether basic and personalized patient decision aids and clinician alerts increased use of CRC ...
Multi-faceted strategies to advance health equity in colorectal ...Major interventions included the use of a patient-navigator, leveraging digital health technology to create a novel CRC screening data dashboard ...
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