Ask Questions (ASQ):Implementation of a Communication Intervention

Sponsor

Barbara Ann Karmanos Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05025748

Collaborator

(none)

225

Enrollment

Locations

Arm

23.2

Anticipated Duration (Months)

28.1

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stage II Breast Cancer Stage III Breast Cancer Stage IV Breast Cancer Stage II Colorectal Cancer Stage III Colorectal Cancer Stage IV Colorectal Cancer Stage II Lung Cancer Stage III Lung Cancer Stage IV Lung Cancer Stage II Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer Stage II Ovarian Cancer Stage III Ovarian Cancer Stage IV Ovarian Cancer Stage II Cervical Cancer Stage III Cervical Cancer Stage II Bladder Cancer Stage III Bladder Cancer Stage IV Bladder Cancer Stage II Kidney Cancer Stage III Kidney Cancer Stage IV Kidney Cancer	Behavioral: Behavioral Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Aug 25, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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)
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)
Perceptions of the Question Prompt List [Post-meeting (Time 3)]
10 items, 5-point Likert scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karmanos Cancer Institute at McLaren Bay Region	Bay City	Michigan	United States	48706
2	Karmanos Cancer Institute at McLaren Clarkston	Clarkston	Michigan	United States	48346
3	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
4	Karmanos Cancer Institute at McLaren Flint	Flint	Michigan	United States	48532
5	Karmanos Cancer Institute at McLaren Macomb	Mount Clemens	Michigan	United States	48043
6	Karmanos Cancer Institute at McLaren Central Michigan	Mount Pleasant	Michigan	United States	48858
7	Karmanos Cancer Institute at McLaren Northern Michigan	Petoskey	Michigan	United States	49770
8	Karmanos Cancer Institute at McLaren Port Huron	Port Huron	Michigan	United States	48060