Facilitating Oncology Patient-Clinician Communication Via E-health Innovations
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ClinicalTrials.gov Identifier: NCT03442127 |
Recruitment Status :
Completed
First Posted : February 22, 2018
Last Update Posted : May 15, 2020
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Sponsor:
University of Nebraska
Information provided by (Responsible Party):
Robin Lally, PhD, RN, University of Nebraska
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Patient-clinician communication using CaringGuidance Summary Report Form [ Time Frame: during clinical encounter, approximately 20 minutes ] qualitative description of psychosocial topics discussed
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Original Secondary Outcome Measures ICMJE |
Patient-clinician communication [ Time Frame: during clinical encounter, approximately 20 minutes ] qualitative description of psychosocial topics discussed
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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 |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Behavioral: CaringGuidance™ After Breast Cancer Diagnosis
Web-based, psychoeducational, self-management tool
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Study Arms ICMJE | Patient Group
Program users
Intervention: Behavioral: CaringGuidance™ After Breast Cancer Diagnosis
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
31 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Robin Lally, PhD, RN, University of Nebraska | ||||
Study Sponsor ICMJE | University of Nebraska | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |