Facilitating Oncology Patient-Clinician Communication Via E-health Innovations

NCT03442127 | Completed DMC

• 1 other identifier: 0432-17-EP
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The Internet-based program CaringGuidance™ After Breast Cancer Diagnosis and its new electronic Summary Report (CGSR) tool are hypothesized to empower patients to raise their emotional and social concerns during oncology consultations and assist medical oncology clinicians in identifying patient needs. This study will assess satisfaction and feasibility of clinical use of the new patient guided, Internet-based CGSR to support patient-clinician communication in the outpatient breast oncology clinic. Participants will have access to the CaringGuidance™ program for home use on computer or mobile device. Following this, paricipants will meet with an investigator prior to a medical oncology appointment and create a CGSR on an iPad while they talk through the process. These assessments will help characterize the emotional state at the time of working with the program and the CGSR. Participants will take the CGSR into their oncology appointment, record the appointment if she and the physician have consented to this, and use the CGSR as much or as little as desired. Data will be analyzed primarily qualitatively to determine participant's appraisal of the functionality, content satisfaction and usability of the CGSR and communication patterns, topics discussed during the appointment and patient/clinician satisfaction with communication during the appointment when the CGSR was available for use.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Patient Satisfaction with the Content of the CaringGuidance Summary Report Form

  qualitative description from the patient regarding their satisfaction with the content of the CaringGuidance Summary Report

  1 minute

• Functionality of the CaringGuidance Summary Report Form

  qualitative description of the functioning of the CaringGuidance Summary Report

  10 minutes

• Usability of the CaringGuidance Summary Report From

  quantitative measure of usability of the form by the System Usability Scale a 10 item scale (strongly disagree to strongly agree) developed by John Brookes 1986 at Digital Equipment Corporation and used in multiple studies.The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a System Usability Scale score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.

  20 minutes

Secondary Outcomes (1)

• Patient-clinician communication using CaringGuidance Summary Report Form

  during clinical encounter, approximately 20 minutes

Study Arms (1)

Patient Group

OTHER

Program users

Behavioral: CaringGuidance™ After Breast Cancer Diagnosis

Interventions

CaringGuidance™ After Breast Cancer Diagnosis BEHAVIORAL

Web-based, psychoeducational, self-management tool

Patient Group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first, stage I - IV breast cancer
• have had at least 1 appointment with a medical oncologist with additional -appointments planned at University of Nebraska Medical Center/Nebraska Medicine clinics,
• able to read and speak English,
• have regular access to Internet and computer,
• have email

You may not qualify if:

• Male,
• mentally or physically unable to consent or use the CaringGuidance program (e.g. hospitalized in the past year with a substance abuse or mental health condition)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Oncology Clinics

Omaha, Nebraska, 68131, United States

Location

Related Publications (1)

• Lally RM, McNees P, Meneses K. Application of a novel transdisciplinary communication technique to develop an Internet-based psychoeducational program: CaringGuidance After Breast Cancer Diagnosis. Appl Nurs Res. 2015 Feb;28(1):e7-11. doi: 10.1016/j.apnr.2014.10.006. Epub 2014 Oct 31.

  PMID: 25467063 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robin M Lally, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 22, 2018
• Study Start: January 31, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)