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 Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
293
Communication intervention called a question prompt list
Karmanos Cancer Institute at McLaren Bay Region
Bay City, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, United States
RECRUITINGEffectiveness - 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)
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 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
Time frame: 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.
Time frame: From Baseline (Time 1) to end of Pre-Clinic Visit (Time 2)
Effectiveness - Knowledge - Quantitative Scale
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Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Lapeer
Lapeer, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Macomb
Mount Clemens, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center
Mount Pleasant, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Northern Michigan
Petoskey, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, United States
RECRUITINGImprovement 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 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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?)
Time frame: From Baseline (Time 1) to up to 3 months