Ask Questions (ASQ):Implementation of a Communication Intervention

Not Applicable

Completed

• Conditions: Stage II Colorectal Cancer; Stage III Colorectal Cancer; Stage II Lung Cancer; Stage III Lung Cancer; Stage III Ovarian Cancer; Stage III Bladder Cancer; Stage IV Breast Cancer; Stage IV Lung Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer
• Interventions: Behavioral: Behavioral Intervention

• Registration Number: NCT05025748
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Brief Summary

This clinical trial implements a communication intervention to improve patient-oncologist communication in the outpatient medical oncology setting. A communication brochure called the ASQ brochure may help patients prepare for the doctor visit by thinking through the questions that patients and patients' family want to ask the doctor.

Detailed Description

Patient-centered communication is critical to providing high-quality care. In patient-provider clinical interactions, providers are responsible for several aspects of patient-centered communication. However, to reach the goal of providing the best possible treatments, patients should also actively participate by asking questions and expressing their concerns. Question prompt lists, simple lists of questions provided to patients before clinic visits to help them prepare for the appointment, have been tested in several medical contexts and patient populations, including among an underserved, minority population in Detroit, and have been shown to contribute to improved outcomes related to better communication quality. Using a RE-AIM framework, this descriptive, mixed methods, single-arm intervention study assesses the implementation of an evidence-based communication intervention (question prompt list), the "ASQ brochure". The ASQ brochure is designed to improve patient-oncologist communication and other outcomes by improving patient self-efficacy for managing patient-physician interactions. Investigators will recruit 225 patients and implement the ASQ brochure at seven Karmanos Cancer Center network sites. Participants are newly diagnosed patients with (Stages I-IV) cancer for which systemic therapy is likely a recommended treatment.

Study Timeline

• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-23
• Study Start: 2021-08-25
• Study First Posted: 2021-08-27
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Adults 18 years of age or older
• Have a first appointment to see a medical oncologist at a Karmanos Cancer Institute (KCC) site for medical/systemic treatment for a new, confirmed diagnosis of stages I-IV cancer
• Speak and read English well enough to be able to understand consent documents
• Given the diverse population seen at KCI, we will make attempts to recruit a representative sample. Our strategy will be simply to ask recruiters to make special attempts to recruit a representative sample. If that strategy fails after the first 10 patients we will build in requirements that at least 25% of the patients self-identify as non-White

Exclusion Criteria

• Not specified

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health services research (ASQ brochure)	Behavioral Intervention	Patients receive ASQ brochure and complete questionnaires over 30 minutes at baseline, over 10 minutes pre-clinic visit, and over 30 minutes post-clinic visit.

Primary Outcome Measures

Name	Time	Method
Self-efficacy in managing patient-physician interactions	Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)	20 items, 5-point Likert scale

Secondary Outcome Measures

Name	Time	Method
Change in distress	Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)	Distress thermometer (one item, Likert scale (no distress - extreme distress)
Change in knowledge related to the patient's cancer and treatment	Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)	6 investigator-developed questions; 5-point Likert scale (strongly disagree - strongly agree)
Change in trust in physicians	Baseline (Time 1) to post-clinic visit (Time 3)	generally (before) and in a specific physician (after): (5 items20 Likert scale)
Perceptions of the Question Prompt List	Post-meeting (Time 3)	10 items, 5-point Likert scale

Trial Locations

Locations (8)

Karmanos Cancer Institute at McLaren Clarkston; 🇺🇸 Clarkston, Michigan, United States

Karmanos Cancer Institute at McLaren Bay Region; 🇺🇸 Bay City, Michigan, United States

Karmanos Cancer Institute at McLaren Flint; 🇺🇸 Flint, Michigan, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Karmanos Cancer Institute at McLaren Northern Michigan; 🇺🇸 Petoskey, Michigan, United States

Karmanos Cancer Institute at McLaren Macomb; 🇺🇸 Mount Clemens, Michigan, United States

Karmanos Cancer Institute at McLaren Central Michigan; 🇺🇸 Mount Pleasant, Michigan, United States

Karmanos Cancer Institute at McLaren Port Huron; 🇺🇸 Port Huron, Michigan, United States