Ask Questions About Clinical Trials (ASQ-CT)

August 4, 2026 updated by: Lauren Hamel, Barbara Ann Karmanos Cancer Institute

Ask Questions About Clinical Trials (ASQ - CT): An Implementation Trial of a Communication Intervention to Improve Patient-Provider Communication About Clinical Trials and Provider Invitations to Clinical Trials

The overall goal of this study is to assess the implementation of the Ask Questions about Clinical Trials (ASQ-CT) brochure, a patient-focused communication tool previously demonstrated to improve patient-provider communication about clinical trials. Participants will be given the ASQ-CT brochure at Time 1 (baseline) and participants will complete a questionnaire at three timepoints, baseline (Time 1), Pre-Research Visit (Time 2), and Post-Research Visit (Time 3).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
293

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • Karmanos Cancer Institute at McLaren Bay Region
        • Contact:
          • Phone Number: 989-667-2370
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Karmanos Cancer Institute at McLaren Clarkston
        • Contact:
          • Phone Number: 248-922-6650
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Karmanos Cancer Institute at McLaren Greater Lansing
        • Contact:
          • Phone Number: 517-975-9500
      • Lapeer, Michigan, United States, 48446
        • Recruiting
        • Karmanos Cancer Institute at McLaren Lapeer
        • Contact:
          • Phone Number: 810-667-4994
      • Mount Clemens, Michigan, United States, 48043
        • Recruiting
        • Karmanos Cancer Institute at McLaren Macomb
        • Contact:
          • Phone Number: 586-493-7510
      • Mount Pleasant, Michigan, United States, 48858
        • Recruiting
        • Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center
        • Contact:
          • Phone Number: 989-772-6811
      • Petoskey, Michigan, United States, 49770
        • Recruiting
        • Karmanos Cancer Institute at McLaren Northern Michigan
        • Contact:
          • Phone Number: 231-487-4209
      • Port Huron, Michigan, United States, 48060
        • Recruiting
        • Karmanos Cancer Institute at McLaren Port Huron
        • Contact:
          • Phone Number: 810-982-5200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > or equal to 18 years
  • Appointment to see a provider at a Karmanos Cancer Institute-McLaren or a medical encounter at McLaren Center for Research and Innovation (MCRI) site for medical/systemic treatment
  • Potentially eligible for a clinical trial
  • Speak and read English well enough to be able to understand consent documents and complete surveys

Exclusion Criteria:

  • Not able to complete study documents on their own physically or cognitively

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ask Questions about Clinical Trials (ASQ-CT) Brochure
Ask Questions about Clinical Trials (ASQ-CT), a clinical trial communication intervention brochure
Behavioral: Ask Questions about Clinical Trials brochure
Communication intervention called a question prompt list

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale
Time Frame: From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Improvement of self-efficacy in managing patient-providers interactions between baseline (Time 1) and pre-clinic visit (Time 2). Measured using scale of 1-5 where a higher score is equal to a better outcome
From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reach - Number and Proportion
Time Frame: At start of Participation
Proportion of individuals invited to participate who agree to participate. The denominator will be the absolute number of individuals who are identified and approached as potential participants; the numerator will be the number of people who agreed to participate. Investigators will track the number of people who were excluded from participation and why. Investigators anticipate that reach will vary by research site and patient baseline characteristic (i.e., sociodemographic, health literacy level). These variations between clinics will be based only on consented participants. Although the Investigators will track refusals, data will not be collected from patients who decline.
At start of Participation
Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale
Time Frame: From Pre-Clinic (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months.
Improvement of self-efficacy in managing patient-providers interactions between baseline (Time 2) and pre-clinic visit (Time 3). Measured using scale of 1-5 where a higher score is equal to a better outcome
From Pre-Clinic (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months.
Effectiveness - Knowledge - Quantitative Scale
Time Frame: From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Improvement of knowledge between baseline (Time 1) and pre-clinic visit (Time 2). Measured using scale of 1-5 where a higher score is equal to a better outcome.
From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Effectiveness - Knowledge - Quantitative Scale
Time Frame: From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months
Improvement of knowledge between pre-clinic visit (Time 2) and post-clinic visit (Time 3). Measured using scale of 1-5 where a higher score is equal to a better outcome
From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months
Effectiveness - Trust - Quantitative Scale
Time Frame: From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Improvement in trust in providers between baseline (Time 1) and pre-clinic visit (Time 2). Measured using scale of 1-5 where a higher score is equal to a better outcome
From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Effectiveness - Trust - Quantitative Scale
Time Frame: From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months
Improvement in trust in providers between pre-clinic visit (Time 2) and post-clinic visit (Time 3). Measured using scale of 1-5 where a higher score is equal to a better outcome
From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months
Effectiveness - distress - Quantitative Scale
Time Frame: From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Improvement in distress between baseline (Time 1) and pre-clinic visit (Time 2). Measured using scale of 1-5 where a higher score is equal to a worse outcome.
From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Effectiveness - distress - Quantitative Scale
Time Frame: From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months
Improvement in distress between pre-clinic visit (Time 2) and post-clinic visit (Time 3). Measured using scale of 1-5 where a higher score is equal to a worse outcome.
From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months
Adoption - Number and Proportion
Time Frame: At start of Participation
Adoption is defined by the number, proportion, and representativeness of the clinics willing to implement the Ask Questions about Clinical Trials (ASQ-CT) brochure. The denominator will be the absolute number of clinics who are invited to implement the ASQ-CT brochure; the numerator will be the number of clinics who agree to implement the ASQ-CT brochure.
At start of Participation
Implementation of the Intervention
Time Frame: From Baseline (Time 1) to up to 3 months
Implementation is defined as intervention agents' (e.g., research/clinic staff) fidelity to the adaptations of the intervention and associated implementation strategies. Patients will receive the Ask Questions about Clinical Trials (ASQ-CT) brochure in Time 1. In Time 2, patients will be asked to respond to two fidelity (yes/no) questions, including: 1. When the participant received the ASQ-CT brochure, did the participant receive instructions on how to use it from the clinic/research staff (yes/no)? Was the participant given the chance to discuss the ASQ-CT brochure with clinic/research staff (yes/no?)
From Baseline (Time 1) to up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Barbara Ann Karmanos Cancer Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lauren M Hamel, PhD, MBA, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-082

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings