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Ask Questions (ASQ):Implementation of a Communication Intervention

Primary Purpose

Stage II Breast Cancer, Stage III Breast Cancer, Stage IV Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stage II Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Karmanos Cancer Institute at McLaren Bay Region
  • Karmanos Cancer Institute at McLaren Clarkston
  • Karmanos Cancer Institute
  • Karmanos Cancer Institute at McLaren Flint
  • Karmanos Cancer Institute at McLaren Macomb
  • Karmanos Cancer Institute at McLaren Central Michigan
  • Karmanos Cancer Institute at McLaren Northern Michigan
  • Karmanos Cancer Institute at McLaren Port Huron

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health services research (ASQ brochure)

Arm Description

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.

Outcomes

Primary Outcome Measures

Self-efficacy in managing patient-physician interactions
20 items, 5-point Likert scale

Secondary Outcome Measures

Change in knowledge related to the patient's cancer and treatment
6 investigator-developed questions; 5-point Likert scale (strongly disagree - strongly agree)
Change in trust in physicians
generally (before) and in a specific physician (after): (5 items20 Likert scale)
Change in distress
Distress thermometer (one item, Likert scale (no distress - extreme distress)
Perceptions of the Question Prompt List
10 items, 5-point Likert scale

Full Information

First Posted
August 2, 2021
Last Updated
August 14, 2023
Sponsor
Barbara Ann Karmanos Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05025748
Brief Title
Ask Questions (ASQ):Implementation of a Communication Intervention
Official Title
Ask Questions (ASQ): Implementation of a Communication Intervention to Improve Patient-Oncologist Communication in the Outpatient Medical Oncology Setting
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health services research (ASQ brochure)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaires
Primary Outcome Measure Information:
Title
Self-efficacy in managing patient-physician interactions
Description
20 items, 5-point Likert scale
Time Frame
Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Secondary Outcome Measure Information:
Title
Change in knowledge related to the patient's cancer and treatment
Description
6 investigator-developed questions; 5-point Likert scale (strongly disagree - strongly agree)
Time Frame
Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Title
Change in trust in physicians
Description
generally (before) and in a specific physician (after): (5 items20 Likert scale)
Time Frame
Baseline (Time 1) to post-clinic visit (Time 3)
Title
Change in distress
Description
Distress thermometer (one item, Likert scale (no distress - extreme distress)
Time Frame
Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Title
Perceptions of the Question Prompt List
Description
10 items, 5-point Likert scale
Time Frame
Post-meeting (Time 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Eggly, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karmanos Cancer Institute at McLaren Bay Region
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Karmanos Cancer Institute at McLaren Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Karmanos Cancer Institute at McLaren Flint
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Karmanos Cancer Institute at McLaren Macomb
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Facility Name
Karmanos Cancer Institute at McLaren Central Michigan
City
Mount Pleasant
State/Province
Michigan
ZIP/Postal Code
48858
Country
United States
Facility Name
Karmanos Cancer Institute at McLaren Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Karmanos Cancer Institute at McLaren Port Huron
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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