Ask Questions About Clinical Trials
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Ann Karmanos Cancer Institute
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Not able to complete study documents on their own physically or cognitively
Trial design
Design model
Single group
Treatments tested in this trial
Ask Questions about Clinical Trials brochure
BehavioralCommunication intervention called a question prompt list
Treatment groups
293 Participants
are divided into 1 treatment groupGroup A: Ask Questions about Clinical Trials (ASQ-CT) BrochureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)Secondary outcomes
1
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.
Time frame
At start of Participation2
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
Time frame
From Pre-Clinic (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months.3
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.
Time frame
From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)4
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
Time frame
From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov