Clinical trial NCT05025748: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Self-efficacy in managing patient-physician interactions
timeFrame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Secondary outcomes:
measure: Change in knowledge related to the patient's cancer and treatment
timeFrame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
measure: Change in trust in physicians
timeFrame: Baseline (Time 1) to post-clinic visit (Time 3)
measure: Change in distress
timeFrame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
measure: Perceptions of the Question Prompt List
timeFrame: Post-meeting (Time 3)
Other outcomes:
Locations:
city: Bay City
country: United States
facility: Karmanos Cancer Institute at McLaren Bay Region
state: Michigan
city: Clarkston
country: United States
facility: Karmanos Cancer Institute at McLaren Clarkston
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Karmanos Cancer Institute at McLaren Flint
state: Michigan
city: Mount Clemens
country: United States
facility: Karmanos Cancer Institute at McLaren Macomb
state: Michigan
city: Mount Pleasant
country: United States
facility: Karmanos Cancer Institute at McLaren Central Michigan
state: Michigan
city: Petoskey
country: United States
facility: Karmanos Cancer Institute at McLaren Northern Michigan
state: Michigan
city: Port Huron
country: United States
facility: Karmanos Cancer Institute at McLaren Port Huron
state: Michigan
Study officials:
affiliation: Wayne State University
name: Susan Eggly, PhD
role: PRINCIPAL_INVESTIGATOR
References: