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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 293
- Locations
- 8
- Primary Endpoint
- Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ask Questions about Clinical Trials (ASQ-CT) Brochure
Ask Questions about Clinical Trials (ASQ-CT), a clinical trial communication intervention brochure
Intervention: Ask Questions about Clinical Trials brochure (Behavioral)
Outcomes
Primary Outcomes
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
- Reach - Number and Proportion(At start of Participation)
- Effectiveness - Self-Efficacy in managing patient-provider interactions - Quantitative Scale(From Pre-Clinic (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months.)
- Effectiveness - Knowledge - Quantitative Scale(From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2))
- Effectiveness - Knowledge - Quantitative Scale(From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months)
- Effectiveness - Trust - Quantitative Scale(From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2))
- Effectiveness - Trust - Quantitative Scale(From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months)
- Effectiveness - distress - Quantitative Scale(From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2))
- Effectiveness - distress - Quantitative Scale(From Pre-Clinic Visit (Time 2) to end of Post-Clinic Visit (Time 3) up to 3 months)
- Adoption - Number and Proportion(At start of Participation)
- Implementation of the Intervention(From Baseline (Time 1) to up to 3 months)
Investigators
Lauren Hamel
Principal Investigator
Barbara Ann Karmanos Cancer Institute