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Facilitating Oncology Patient-Clinician Communication Via E-health Innovations

Facilitating Oncology Patient-Clinician Communication Via E-health Innovations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03442127
Enrollment
31
Registered
2018-02-22
Start date
2018-01-31
Completion date
2019-12-20
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

BEHAVIORALCaringGuidance™ After Breast Cancer Diagnosis

Web-based, psychoeducational, self-management tool

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Patient Satisfaction with the Content of the CaringGuidance Summary Report Form1 minutequalitative description from the patient regarding their satisfaction with the content of the CaringGuidance Summary Report
Functionality of the CaringGuidance Summary Report Form10 minutesqualitative description of the functioning of the CaringGuidance Summary Report
Usability of the CaringGuidance Summary Report From20 minutesquantitative 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

MeasureTime frameDescription
Patient-clinician communication using CaringGuidance Summary Report Formduring clinical encounter, approximately 20 minutesqualitative description of psychosocial topics discussed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026