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NCT Number: NCT07343297

Ask Questions About 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ask Questions about Clinical Trials brochure

Behavioral

Communication intervention called a question prompt list

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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?)

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren M Hamel, PhD, MBA

CONTACT

[email protected]

1-800-527-6266

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Registry information

Official study 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

Acronym: ASQ-CT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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