Ask Questions About Clinical Trials

Browse trials for

• Neoplasms 10,818
• Heart Diseases 2,135
• Nervous System Diseases 757

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 293 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Lead sponsor

Barbara Ann Karmanos Cancer Institute is the lead sponsor of 161 studies on the registry; 19 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Study arms

• Experimental
  Ask Questions about Clinical Trials (ASQ-CT) Brochure

  Ask Questions about Clinical Trials (ASQ-CT), a clinical trial communication intervention brochure

  Behavioral: Ask Questions about Clinical Trials brochure

Interventions

• BehavioralAsk Questions about Clinical Trials brochure

  Communication intervention called a question prompt list

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 Participation

2. 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 months

5. 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)

6. 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

7. 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)

8. 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

9. 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

10. 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