Ask Questions About Clinical Trials (ASQ-CT)

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: Not yet recruiting
• Conditions: Neurologic Disorder; Oncology; Cardiac Disease
• Intervention / Treatment: Behavioral: Ask Questions about Clinical Trials brochure

• Study Type: Interventional
• Enrollment (Estimated): 293
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren M Hamel, PhD, MBA; Phone Number: 1-800-527-6266; Email: Lauren.Hamel@med.wayne.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale	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

Outcome Measure	Measure Description	Time Frame
Reach - Number and Proportion	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	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	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	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	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	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	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	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	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	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

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Investigators: Principal Investigator: Lauren M Hamel, PhD, MBA, Wayne State University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 5, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Neoplasms; Heart Diseases; Nervous System Diseases
• Other Study ID 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