Clinical trial NCT03442127: Facilitating Oncology Patient-Clinician Communication Via E-health Innovations
Official title: Facilitating Oncology Patient-Clinician Communication Via E-health Innovations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 31
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 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.

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)

Primary outcomes:
measure: Patient Satisfaction with the Content of the CaringGuidance Summary Report Form
timeFrame: 1 minute
measure: Functionality of the CaringGuidance Summary Report Form
timeFrame: 10 minutes
measure: Usability of the CaringGuidance Summary Report From
timeFrame: 20 minutes
Secondary outcomes:
measure: Patient-clinician communication using CaringGuidance Summary Report Form
timeFrame: during clinical encounter, approximately 20 minutes
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Oncology Clinics
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Robin M Lally, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.