Survivor & Provider Activation for Colorectal Cancer Screening

(ASPIRES Trial)

Recruiting at 4 trial locations

Overseen By Melissa Marx, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Non-US resident, Non-English speaker

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to assess the best method for encouraging high-risk cancer survivors to get screened for colorectal cancer at the recommended age.

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 data supports the effectiveness of the treatment Survivor & Provider Activation for Colorectal Cancer Screening?

Research shows that shared decision making (SDM) can help increase patient engagement and adherence to colorectal cancer screening. However, the use of decision aids, which are tools to help with SDM, is not yet common in clinical practice, indicating a need for more integration and support in healthcare settings. ^{1 2 3 4 5}

Is the shared decision making approach for colorectal cancer screening safe for humans?

The research articles do not provide specific safety data for the shared decision making approach, but this method generally involves discussions between patients and doctors to make informed choices, which is considered safe as it focuses on communication and understanding rather than medical procedures. ^{1 2 3 5 6}

How does the Survivor & Provider Activation for Colorectal Cancer Screening treatment differ from other treatments for colorectal cancer?

This treatment is unique because it focuses on improving shared decision making between patients and healthcare providers through the use of a computer-based decision aid. This approach helps clarify patient preferences and enhances communication, which can lead to increased adherence to colorectal cancer screening, especially in underserved populations. ^{1 6 7 8 9}

Research Team

Tara Henderson, MD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Karen Kim, MD, MS

Principal Investigator

The Pennsylvania State University

Eligibility Criteria

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.

Exclusion Criteria

Do not reside in the United States

I do not speak English.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Group1: Control (C) Experimental Treatment 1 Intervention

Electronic educational materials (C).

Group II: Group 3: Patient Activation and PCP Activation (PA + PCP) Experimental Treatment 3 Interventions

C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population

Group III: Group 2: Patient Activation (PA) Experimental Treatment 2 Interventions

C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The impact of a novel computer-based decision aid on shared decision making for colorectal cancer screening: a randomized trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

An effort to spread decision aids in five California primary care practices yielded low distribution, highlighting hurdles. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Primary Care Physicians' Support of Shared Decision Making for Different Cancer Screening Decisions. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a multilevel implementation program for timeout and shared decision making in breast cancer care: a mixed methods study among 11 hospital teams. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Talking, not training, increased the accuracy of physicians' diagnosis of their patients' preferences for colon cancer screening. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Colorectal Cancer Screening in Vulnerable Patients: Promoting Informed and Shared Decisions. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Process evaluation in an intervention designed to improve rates of colorectal cancer screening in a VA medical center. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Low Colorectal Cancer Screening Uptake and Persistent Disparities in an Underserved Urban Population. [2021]