OncologyASQ-CTNCT07343297
Ask Questions About Clinical Trials
A study testing Ask Questions about Clinical Trials brochure in people with Oncology and Cardiac Disease, run by Barbara Ann Karmanos Cancer Institute at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Cardiac Disease, Neurologic Disorder
- What is being tested?
- Ask Questions about Clinical Trials brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Dec 2026to 5 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not able to complete study documents on their own physically or cognitively
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, 48706
989-667-2370
- Recruiting
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
248-922-6650
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
517-975-9500
- Recruiting
Karmanos Cancer Institute at McLaren Lapeer
Lapeer, Michigan, 48446
810-667-4994
- Recruiting
Karmanos Cancer Institute at McLaren Macomb
Mount Clemens, Michigan, 48043
586-493-7510
- Recruiting
Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center
Mount Pleasant, Michigan, 48858
989-772-6811
- Recruiting
Karmanos Cancer Institute at McLaren Northern Michigan
Petoskey, Michigan, 49770
231-487-4209
- Recruiting
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060
810-982-5200
About this study
Official title: 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).
- Conditions
- Oncology, Cardiac Disease, Neurologic Disorder
- Being tested
- Ask Questions about Clinical Trials brochure
- Medical subject headings
- Neoplasms, Heart Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ask Questions about Clinical Trials brochureBehavioural
Communication intervention called a question prompt list
| Study group | Role | What they receive |
|---|---|---|
| Ask Questions about Clinical Trials (ASQ-CT) Brochure | Experimental | Ask Questions about Clinical Trials (ASQ-CT), a clinical trial communication intervention brochure Receives: Behavioral: Ask Questions about Clinical Trials brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Secondary outcomes (10)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?)
Measured: From Baseline (Time 1) to up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion5 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 293 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Hamel, Barbara Ann Karmanos Cancer Institute
- Investigators
- Lauren M Hamel, PhD, MBA, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343297
- Sponsor's protocol ID
- 2025-082
- Acronym
- ASQ-CT
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07343297
- Acronym / sponsor ID
- ASQ-CT / 2025-082
- Conditions
- Oncology, Cardiac Disease, Neurologic Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 293 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 5 Apr 2028 (estimated)
- First posted
- 15 Jan 2026 (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 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ask Questions about Clinical Trials (ASQ-CT) Brochure | Experimental | Behavioral: Ask Questions about Clinical Trials brochureAsk Questions about Clinical Trials (ASQ-CT), a clinical trial communication intervention brochure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not able to complete study documents on their own physically or cognitively
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 |
|---|---|---|
| Ask Questions about Clinical Trials brochureCommunication intervention called a question prompt list | Behavioural | Ask Questions about Clinical Trials (ASQ-CT) Brochure |
Primary outcome
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
10 secondary outcomes
Reach - Number and Proportion
Time frame: 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.
Effectiveness - Knowledge - Quantitative Scale
Time frame: 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
Effectiveness - Trust - Quantitative Scale
Time frame: 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
Effectiveness - distress - Quantitative Scale
Time frame: 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
Adoption - Number and Proportion
Time frame: At start of Participation
Implementation of the Intervention
Time frame: From Baseline (Time 1) to up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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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.
Lauren M Hamel, PhD, MBA principal investigator
Wayne State University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ask Questions about Clinical Trials brochure in people with Oncology and Cardiac Disease, run by Barbara Ann Karmanos Cancer Institute at 8 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren M Hamel, PhD, MBA (1-800-527-6266, Lauren.Hamel@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale (time frame: From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.