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Facilitating Oncology Patient-Clinician Communication Via E-health Innovations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03442127
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Robin Lally, PhD, RN, University of Nebraska

Tracking Information
First Submitted Date  ICMJE February 2, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date May 15, 2020
Actual Study Start Date  ICMJE January 31, 2018
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • 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
  • Functionality of the CaringGuidance Summary Report Form [ Time Frame: 10 minutes ]
    qualitative description of the functioning of the CaringGuidance Summary Report
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Patient-clinician communication using CaringGuidance Summary Report Form [ Time Frame: during clinical encounter, approximately 20 minutes ]
qualitative description of psychosocial topics discussed
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Patient-clinician communication [ Time Frame: during clinical encounter, approximately 20 minutes ]
qualitative description of psychosocial topics discussed
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facilitating Oncology Patient-Clinician Communication Via E-health Innovations
Official Title  ICMJE Facilitating Oncology Patient-Clinician Communication Via E-health Innovations
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE Behavioral: CaringGuidance™ After Breast Cancer Diagnosis
Web-based, psychoeducational, self-management tool
Study Arms  ICMJE Patient Group
Program users
Intervention: Behavioral: CaringGuidance™ After Breast Cancer Diagnosis
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
30
Actual Study Completion Date  ICMJE December 20, 2019
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03442127
Other Study ID Numbers  ICMJE 432-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robin Lally, PhD, RN, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robin M Lally, PhD, RN University of Nebraska
PRS Account University of Nebraska
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP