Colorectal CancerASPIRESNCT05084833
ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study
A study testing Patient activation and Primary care provider activation in people with Colorectal Cancer and Early Detection of Cancer, run by Ann & Robert H Lurie Children's Hospital of Chicago at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Colorectal Cancer, Early Detection of Cancer
- What is being tested?
- Patient activation and Primary care provider activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Feb 2022to 30 Oct 2025
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will include people who:
- Enrolled on the Childhood Cancer Survivor Study
- Were treated with radiation to the abdomen, pelvis, spine, or total body irradiation
- Have no history of colorectal cancer
- Have not had a colonoscopy in the last 5 years or Cologuard in the last 3 years
- Have a smartphone
Who cannot join
- Do not reside in the United States
- Do not speak English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Memorial Sloan Kettering Cancer Center
New York, New York, 10017
Columbia University
New York, New York, 10027
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
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.
Read the detailed description
This is a 12-month, 3-arm randomized controlled trial of 315 Childhood Cancer Survivor Study (CCSS) survivors using a text message intervention with data collected at baseline and 12 months through patient and provider surveys and interviews and a medical record review. Participants will be randomly assigned to one of three groups: control, patient activation (PA) using a text message/video intervention, or patient activation + primary care provider activation (PA + PCP) which will include providing primary care providers with resources about colorectal cancer risk in this population. All participants will receive electronic resources about their previous cancer treatment and colorectal cancer screening recommendations.
The primary outcome is the proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if the Cologuard is positive) within 12 months of enrolling on the study, as measured via self-report questions in the end of study questionnaire. The study will test the hypothesis that, compared to controls, survivors randomized to the PA and PA + PCP activation groups will have significantly higher rates of completion of colorectal cancer screening.
- Conditions
- Colorectal Cancer, Early Detection of Cancer
- Being tested
- Control, Patient activation, Primary care provider activation
- Keywords
- Colorectal cancer, cancer survivor
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Electronic educational materials
Patient activationBehavioural
Interactive text messages with links to videos (e.g. colorectal cancer screening options, cost of colorectal cancer screening, perspective from a cancer survivor, why regular appointments are important for cancer survivors) and resources (e.g. helpful websites) are sent to participants
Primary care provider activationBehavioural
Faxed educational materials (e.g. current colorectal cancer screening recommendations, frequently asked questions, insurance letter template, cover letter with overview of patient's cancer treatment history) sent to primary care providers
| Study group | Role | What they receive |
|---|---|---|
| Group1: Control (C) | Experimental | Electronic educational materials (C). Receives: Behavioral: Control |
| Group 2: Patient Activation (PA) | Experimental | C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources Receives: Behavioral: Control; Behavioral: Patient activation |
| Group 3: Patient Activation and PCP Activation (PA + PCP) | Experimental | C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population Receives: Behavioral: Control; Behavioral: Patient activation; Behavioral: Primary care provider activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization
This will be measured by self-report on a questionnaire given at 12 months.
Measured: 12 months
Secondary outcomes (4)
Proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization as measured in medical record reports
The study team will confirm if participants had a colonoscopy or cologuard test by reaching out to the medical site where the participant was screened, and requesting the medical record confirmation.
Measured: 12 months
Potential barriers and facilitators to the uptake of the intervention at both the patient and provider level as measured by CFIR questions
Consolidated Framework for Implementation Research (CFIR) questions are included in the 12-month questionnaire for participants, the 12-month questionnaire for their primary care providers, and the end of study interviews for the participants, primary care providers, and other medical office staff. CFIR questions are meant to measure 5 domains: intervention characteristics, outer setting, inner setting, characteristics of individuals, and process.
Measured: 14 months
Other potential barriers and facilitators to the uptake of the intervention at both the patient and provider level
In this study, the potential moderators include patient characteristics, such as age, gender, educational attainment, health insurance coverage, types of insurance, chronic health conditions, and race/ethnicity as well as PCP factors such as knowledge, years in practice, and practice setting. The potential mediators in this study may include the patient's perception of involvement in decision making, health insurance coverage, and whether the patient reviewed the study resources and videos. This will be measured through data collected via the baseline and 12 month questionnaires as well as data previously collected via the St. Jude Childhood Cancer Survivor Study.
Measured: 12 months
Cost and Cost-Effectiveness Analysis
We will collect data on the replication costs of the intervention and health services from the intervention per participant. The costs of the intervention (e.g. intervention materials, personnel time, and texting costs) will be collected by the University of Chicago team via a cost spreadsheet. The cost of the health services will be collected via the 12-month questionnaire; participants will be asked to share information about the types of medical visits they have had since joining the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start14 Feb 2022
- Primary completion30 Sep 2025
- Study completion30 Oct 2025
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- St. Jude Children's Research Hospital, Memorial Sloan Kettering Cancer Center, Columbia University, The Hospital for Sick Children, Duke University, Penn State University, Hunter College of City University of New York, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tara O Henderson, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoKaren Kim, MD, MS, Study chair, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084833
- Sponsor's protocol ID
- STUDY00000296
- Other IDs
- R01CA255269-01
- Acronym
- ASPIRES
- Status last verified
- Dec 2025
- First submitted
- 7 Oct 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will be recruited from an established cohort (Childhood Cancer Survivor Study), and therefore individual participant data will not be available to other researchers.
Publications
Henderson TO, Bardwell JK, Moskowitz CS, McDonald A, Vukadinovich C, Lam H, Curry M, Oeffinger KC, Ford JS, Elkin EB, Nathan PC, Armstrong GT, Kim K. Implementing a mHealth intervention to increase colorectal cancer screening among high-risk cancer survivors treated with radiotherapy in the Childhood Cancer Survivor Study (CCSS). BMC Health Serv Res. 2022 May 23;22(1):691. doi: 10.1186/s12913-022-08082-3.
PubMed 35606736
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study
- ClinicalTrials.gov ID
- NCT05084833
- Acronym / sponsor ID
- ASPIRES / STUDY00000296
- Conditions
- Colorectal Cancer, Early Detection of Cancer
- Keywords
- Colorectal cancer, cancer survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- St. Jude Children's Research Hospital, Memorial Sloan Kettering Cancer Center, Columbia University, The Hospital for Sick Children, Duke University, Penn State University, Hunter College of City University of New York, National Cancer Institute (NCI)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 20 Oct 2021 (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.
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.
Detailed description
This is a 12-month, 3-arm randomized controlled trial of 315 Childhood Cancer Survivor Study (CCSS) survivors using a text message intervention with data collected at baseline and 12 months through patient and provider surveys and interviews and a medical record review. Participants will be randomly assigned to one of three groups: control, patient activation (PA) using a text message/video intervention, or patient activation + primary care provider activation (PA + PCP) which will include providing primary care providers with resources about colorectal cancer risk in this population. All participants will receive electronic resources about their previous cancer treatment and colorectal cancer screening recommendations.
The primary outcome is the proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if the Cologuard is positive) within 12 months of enrolling on the study, as measured via self-report questions in the end of study questionnaire. The study will test the hypothesis that, compared to controls, survivors randomized to the PA and PA + PCP activation groups will have significantly higher rates of completion of colorectal cancer screening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1: Control (C) | Experimental | Behavioral: ControlElectronic educational materials (C). |
| Group 2: Patient Activation (PA) | Experimental | Behavioral: Control, Behavioral: Patient activationC + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources |
| Group 3: Patient Activation and PCP Activation (PA + PCP) | Experimental | Behavioral: Control, Behavioral: Patient activation, Behavioral: Primary care provider activationC + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Enrolled on the Childhood Cancer Survivor Study
- Were treated with radiation to the abdomen, pelvis, spine, or total body irradiation
- Have no history of colorectal cancer
- Have not had a colonoscopy in the last 5 years or Cologuard in the last 3 years
- Have a smartphone
Key exclusion criteria (2 listed)
- Do not reside in the United States
- Do not speak English
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 |
|---|---|---|
| ControlElectronic educational materials | Behavioural | Group 2: Patient Activation (PA), Group 3: Patient Activation and PCP Activation (PA + PCP), Group1: Control (C) |
| Patient activationInteractive text messages with links to videos (e.g. colorectal cancer screening options, cost of colorectal cancer screening, perspective from a cancer survivor, why regular appointments are important for cancer survivors) and resources (e.g. helpful websites) are sent to participants | Behavioural | Group 2: Patient Activation (PA), Group 3: Patient Activation and PCP Activation (PA + PCP) |
| Primary care provider activationFaxed educational materials (e.g. current colorectal cancer screening recommendations, frequently asked questions, insurance letter template, cover letter with overview of patient's cancer treatment history) sent to primary care providers | Behavioural | Group 3: Patient Activation and PCP Activation (PA + PCP) |
Primary outcome
Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization
Time frame: 12 months
This will be measured by self-report on a questionnaire given at 12 months.
4 secondary outcomes
Proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization as measured in medical record reports
Time frame: 12 months
Potential barriers and facilitators to the uptake of the intervention at both the patient and provider level as measured by CFIR questions
Time frame: 14 months
Other potential barriers and facilitators to the uptake of the intervention at both the patient and provider level
Time frame: 12 months
Cost and Cost-Effectiveness Analysis
Time frame: 12 months
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 27 May 2026.
- Derived from this study: PubMed 35606736Henderson TO, Bardwell JK, Moskowitz CS, McDonald A, Vukadinovich C, Lam H, Curry M, Oeffinger KC, Ford JS, Elkin EB, Nathan PC, Armstrong GT, Kim K. Implementing a mHealth intervention to increase colorectal cancer screening among high-risk cancer survivors treated with radiotherapy in the Childhood Cancer Survivor Study (CCSS). BMC Health Serv Res. 2022 May 23;22(1):691. doi: 10.1186/s12913-022-08082-3.
- Individual participant dataSharing planned: No. Participants will be recruited from an established cohort (Childhood Cancer Survivor Study), and therefore individual participant data will not be available to other researchers.
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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.
Tara O Henderson, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Karen Kim, MD, MS study chair
The Pennsylvania State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient activation and Primary care provider activation in people with Colorectal Cancer and Early Detection of Cancer, run by Ann & Robert H Lurie Children's Hospital of Chicago at 4 sites 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 6 inclusion and 2 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization (time frame: 12 months). 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 NCT05084833, 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 27 May 2026.