Facilitating Oncology Patient-Clinician Communication Via E-health Innovations

• ClinicalTrials.gov Identifier: NCT03442127
• Recruitment Status: Completed
• First Posted: February 22, 2018
• Last Update Posted: May 15, 2020
• Sponsor: University of Nebraska
• Information provided by (Responsible Party): Robin Lally, PhD, RN, University of Nebraska

Tracking Information

• First Submitted Date: February 2, 2018
• First Posted Date: February 22, 2018
• Last Update Posted Date: May 15, 2020
• Actual Study Start Date: January 31, 2018
• Actual Primary Completion Date: December 20, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Facilitating Oncology Patient-Clinician Communication Via E-health Innovations
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Breast Cancer

Intervention

Behavioral: CaringGuidance™ After Breast Cancer Diagnosis

Web-based, psychoeducational, self-management tool

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 14, 2020): 31
• Original Estimated Enrollment (submitted: February 15, 2018): 30
• Actual Study Completion Date: December 20, 2019
• Actual Primary Completion Date: December 20, 2019 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03442127
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Robin Lally, PhD, RN, University of Nebraska
• Study Sponsor: University of Nebraska
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robin M Lally, PhD, RN; University of Nebraska

• PRS Account: University of Nebraska
• Verification Date: May 2020