Ask Questions (ASQ):Implementation of a Communication Intervention

Stage IV Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025748
• Other study ID #: 2021-025
• Status: Completed
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2023
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ovarian Epithelial
• Carcinoma, Renal Cell
• Colorectal Neoplasms
• Kidney Neoplasms
• Lung Neoplasms
• Ovarian Neoplasms
• Prostatic Neoplasms
• Stage II Bladder Cancer
• Stage II Breast Cancer
• Stage II Cervical Cancer
• Stage II Colorectal Cancer
• Stage II Lung Cancer
• Stage II Ovarian Cancer
• Stage II Prostate Cancer
• Stage III Bladder Cancer
• Stage III Breast Cancer
• Stage III Cervical Cancer
• Stage III Colorectal Cancer
• Stage III Lung Cancer
• Stage III Ovarian Cancer
• Stage III Prostate Cancer
• Stage IV Bladder Cancer
• Stage IV Breast Cancer
• Stage IV Colorectal Cancer
• Stage IV Kidney Cancer
• Stage IV Lung Cancer
• Stage IV Ovarian Cancer
• Stage IV Prostate Cancer
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Behavioral Intervention
Complete questionnaires

Locations

Country	Name	City	State
United States	Karmanos Cancer Institute at McLaren Bay Region	Bay City	Michigan
United States	Karmanos Cancer Institute at McLaren Clarkston	Clarkston	Michigan
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Karmanos Cancer Institute at McLaren Flint	Flint	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 Northern Michigan	Petoskey	Michigan
United States	Karmanos Cancer Institute at McLaren Port Huron	Port Huron	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy in managing patient-physician interactions	20 items, 5-point Likert scale	Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Secondary	Change in knowledge related to the patient's cancer and treatment	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)
Secondary	Change in trust in physicians	generally (before) and in a specific physician (after): (5 items20 Likert scale)	Baseline (Time 1) to post-clinic visit (Time 3)
Secondary	Change in distress	Distress thermometer (one item, Likert scale (no distress - extreme distress)	Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Secondary	Perceptions of the Question Prompt List	10 items, 5-point Likert scale	Post-meeting (Time 3)