Ask Questions (ASQ):Implementation of a Communication Intervention

NCT05025748 | Completed DMC

• 1 other identifier: 2021-025
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

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

• Change in trust in physicians

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

• Change in distress

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

• Perceptions of the Question Prompt List

  Post-meeting (Time 3)

Study Arms (1)

Health services research (ASQ brochure)

EXPERIMENTAL

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

Interventions

Behavioral Intervention BEHAVIORAL

Complete questionnaires

Also known as: Questionnaire Administration

Health services research (ASQ brochure)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not specified

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (8)

Karmanos Cancer Institute at McLaren Bay Region

Bay City, Michigan, 48706, United States

Location

Karmanos Cancer Institute at McLaren Clarkston

Clarkston, Michigan, 48346, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Karmanos Cancer Institute at McLaren Flint

Flint, Michigan, 48532, United States

Location

Karmanos Cancer Institute at McLaren Macomb

Mount Clemens, Michigan, 48043, United States

Location

Karmanos Cancer Institute at McLaren Central Michigan

Mount Pleasant, Michigan, 48858, United States

Location

Karmanos Cancer Institute at McLaren Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Karmanos Cancer Institute at McLaren Port Huron

Port Huron, Michigan, 48060, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Kidney Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susan Eggly, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 27, 2021
• Study Start: August 25, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)