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Facilitating Oncology Patient-Clinician Communication Via E-health Innovations

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ClinicalTrials.gov Identifier: NCT03442127
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Robin Lally, PhD, RN, University of Nebraska

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. The purpose of this study is to 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. The study will enroll 30 women who are being treated for breast cancer. They will all have access to the CaringGuidance™ program for at home use on computer or mobile device for approximately one month (or up to 6 months depending on when they return to their primary medical oncologist for evaluation). Following this, these women will meet with the researcher or research assistant prior to a medical oncology appointment and create a CGSR on an iPad while they talk through the process with the researcher. Women will complete demographic data and assessment of coping prior to receiving access to the program and at this appointment. These assessments will help characterize the emotional state at the time of working with the program and the CGSR, these measures are not to assess the efficacy of the program. Clinicians will complete a brief, one-time demographics survey prior to enrollment of patients to the study. Women 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. Clinicians will complete a brief satisfaction survey following the appointment and patients will debrief (recorded) about whether they used the CGSR and their impressions following the appointment. Data will be analyzed primarily qualitatively to determine women's appraisal of the functionality, content satisfaction and usability of the CGSR and the communication patterns, topics discussed during the appointment and patient/clinician satisfaction with communication during the appointment when the CGSR was available for use. Data will be used for future modification of the CGSR to assure that it meets patients' needs prior to initiating a larger scale trial.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: CaringGuidance™ After Breast Cancer Diagnosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Facilitating Oncology Patient-Clinician Communication Via E-health Innovations
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Patient Group
Program users
Behavioral: CaringGuidance™ After Breast Cancer Diagnosis
Web-based, psychoeducational, self-management tool




Primary Outcome Measures :
  1. Patient Satisfaction with the Content of the CaringGuidance Summary Report Form [ Time Frame: 1 minute ]
    qualitative description from the patient regarding their satisfaction with the content of the CaringGuidance Summary Report

  2. Functionality of the CaringGuidance Summary Report Form [ Time Frame: 10 minutes ]
    qualitative description of the functioning of the CaringGuidance Summary Report

  3. Usability of the CaringGuidance Summary Report From [ Time Frame: 20 minutes ]

    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.



Secondary Outcome Measures :
  1. Patient-clinician communication using CaringGuidance Summary Report Form [ Time Frame: during clinical encounter, approximately 20 minutes ]
    qualitative description of psychosocial topics discussed



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442127


Contacts
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Contact: Robin M Lally, PhD, RN 402-559-5464 robin.lally@unmc.edu

Locations
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United States, Nebraska
University of Nebraska Medical Center Oncology Clinics Recruiting
Omaha, Nebraska, United States, 68131
Contact: Robin M Lally, PhD, RN    402-559-5464    robin.lally@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Robin M Lally, PhD, RN University of Nebraska

Publications:
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Responsible Party: Robin Lally, PhD, RN, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03442127     History of Changes
Other Study ID Numbers: 432-17
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No