An interventional study of Behavioral Intervention in Stage II Breast Cancer, Stage III Breast Cancer and Stage IV Breast Cancer, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-16.
Sponsored by Barbara Ann Karmanos Cancer Institute · Not applicable, Interventional, and Health services research
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.
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 81 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: Questionnaire Administration
Self-efficacy in managing patient-physician interactions
20 items, 5-point Likert scale
Time frame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)
Change in knowledge related to the patient's cancer and treatment
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)
Change in trust in physicians
generally (before) and in a specific physician (after): (5 items20 Likert scale)
Time frame: Baseline (Time 1) to post-clinic visit (Time 3)
Change in distress
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)
Perceptions of the Question Prompt List
10 items, 5-point Likert scale
Time frame: Post-meeting (Time 3)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Barbara Ann Karmanos Cancer Institute