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NCT Number: NCT05025748

Ask Questions (ASQ):Implementation of a Communication Intervention

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.

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Key information

Conditions

Stage II Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stage II Bladder Cancer Stage II Cervical Cancer Stage II Colorectal Cancer Stage II Kidney 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 Kidney 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 Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karmanos Cancer Institute at McLaren Bay Region, Bay City, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

Complete questionnaires

Other names: Questionnaire Administration

Primary outcomes

  1. Self-efficacy in managing patient-physician interactions

    Time frame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)

    20 items, 5-point Likert scale

Secondary outcomes

  1. Change in knowledge related to the patient's cancer and treatment

    Time frame: 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)

  2. Change in trust in physicians

    Time frame: Baseline (Time 1) to post-clinic visit (Time 3)

    generally (before) and in a specific physician (after): (5 items20 Likert scale)

  3. Change in distress

    Time frame: Baseline (Time 1) to pre-clinic visit (TIme 2) post-clinic visit (TIme 3)

    Distress thermometer (one item, Likert scale (no distress - extreme distress)

  4. Perceptions of the Question Prompt List

    Time frame: Post-meeting (Time 3)

    10 items, 5-point Likert scale

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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