Ask Questions (ASQ):Implementation of a Communication Intervention

August 14, 2023 updated by: Susan Eggly, Barbara Ann Karmanos Cancer Institute

Ask Questions (ASQ): Implementation of a Communication Intervention to Improve Patient-Oncologist Communication in the Outpatient Medical Oncology Setting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Karmanos Cancer Institute at McLaren Bay Region
      • Clarkston, Michigan, United States, 48346
        • Karmanos Cancer Institute at McLaren Clarkston
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Flint, Michigan, United States, 48532
        • Karmanos Cancer Institute at McLaren Flint
      • Mount Clemens, Michigan, United States, 48043
        • Karmanos Cancer Institute at McLaren Macomb
      • Mount Pleasant, Michigan, United States, 48858
        • Karmanos Cancer Institute at McLaren Central Michigan
      • Petoskey, Michigan, United States, 49770
        • Karmanos Cancer Institute at McLaren Northern Michigan
      • Port Huron, Michigan, United States, 48060
        • Karmanos Cancer Institute at McLaren Port Huron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health services research (ASQ brochure)
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.
Behavioral: Behavioral Intervention
Complete questionnaires
Other Names:
  • Questionnaire Administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ann Karmanos Cancer Institute

Investigators

  • Principal Investigator: Susan Eggly, PhD, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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