Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
779 participants
INTERVENTIONAL
2008-10-31
2013-12-31
Brief Summary
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Detailed Description
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* Patient participants will have already completed one ESRA-C 2 report, which is a usual report in the clinic. If they decide to participate in the study, that report will be used in the study as the first report (Timepoint 1). In addition, they will complete a second report (Timepoint 2) and two more reports (Timepoint 3 and 4). Timepoint 3 will be 6-8 weeks after the participants treatment begins; Timepoint 4 will be 2-4 weeks after their treatment ends.
* The Timepoint 2 report will be within 24 hours before a clinic visit. The conversation between the patient participant and the health care providers will be audio recorded.
* Half of the patient participants will also see additional information in the computer program. The patient participants that are in this group can complete as many more ESRA-C 2 reports as they wish and will be able to read additional information about managing symptoms and quality of life issues, view graphs of their reports, add journal entries, and share all their reports with caregivers.
* Clinician Participants will be asked to report brief demographics (age group, gender, race/ethnicity, position). During clinic appointments, research staff will place a 3" by 5" audio-recorder in the exam room just prior to some of the participant's visits. Recordings will be de-identified before coding.
* After these visits, a research staff member will ask the clinician participant to report briefly on their satisfaction in the visit. The participant can check their responses on a piece of paper or dictate them.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
Patient participants in the intervention arm can access educational information about self-care strategies, track and share reports of their symptoms and quality of life issues over time, and receive coaching on how to discuss these issues with their care team.
Electronic Self-Report Assessment - Cancer (ESRA-C)
The Electronic Self-Report Assessment-Cancer (ESRA-C) is a program allowing patients to report symptoms and quality of life issues and learn information about how to deal with these experiences.
Control
Participants in the control arm access the ESRA-C from home or clinic to self-assess only.
No interventions assigned to this group
Interventions
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Electronic Self-Report Assessment - Cancer (ESRA-C)
The Electronic Self-Report Assessment-Cancer (ESRA-C) is a program allowing patients to report symptoms and quality of life issues and learn information about how to deal with these experiences.
Eligibility Criteria
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Inclusion Criteria
* Perform consults/exams in clinics that have implemented routine use of the ESRA-C 2 screening tool as a standard of care
Eligible patient participants (Inclusion):
* 18 years of age or older
* Diagnosis of malignant disease
* Plan to have treatment in a study clinic
* Speak and read English at a 6th grade level or higher
18 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
University of Washington
OTHER
National Institute of Nursing Research (NINR)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Donna Berry, PhD, RN, FAAN, AOCN
Assoc. Professor, Harvard Medical School; Director, The Phyllis F. Cantor Center, Research in Nursing and Patient Care Services; Affiliate Professor, University of Washington School of Nursing
Principal Investigators
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Donna L. Berry
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Knoerl R, Hong F, Blonquist T, Berry D. Impact of Electronic Self-Assessment and Self-Care Technology on Adherence to Clinician Recommendations and Self-Management Activity for Cancer Treatment-Related Symptoms: Secondary Analysis of a Randomized Controlled Trial. JMIR Cancer. 2019 Jan 8;5(1):e11395. doi: 10.2196/11395.
Knoerl R, Weller E, Halpenny B, Berry D. Exploring the efficacy of an electronic symptom assessment and self-care intervention to preserve physical function in individuals receiving neurotoxic chemotherapy. BMC Cancer. 2018 Dec 4;18(1):1203. doi: 10.1186/s12885-018-5093-z.
Siefert ML, Bonquist TM, Berry DL, Hong F. Symptom-related emergency department visits and hospital admissions during ambulatory cancer treatment. J Community Support Oncol. 2015 May;13(5):188-94. doi: 10.12788/jcso.0134.
Berry DL, Blonquist TM, Patel RA, Halpenny B, McReynolds J. Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress. J Med Internet Res. 2015 Jun 3;17(6):e136. doi: 10.2196/jmir.4190.
Berry DL, Hong F, Halpenny B, Partridge A, Fox E, Fann JR, Wolpin S, Lober WB, Bush N, Parvathaneni U, Amtmann D, Ford R. The electronic self report assessment and intervention for cancer: promoting patient verbal reporting of symptom and quality of life issues in a randomized controlled trial. BMC Cancer. 2014 Jul 12;14:513. doi: 10.1186/1471-2407-14-513.
Hong F, Bosco JL, Bush N, Berry DL. Patient self-appraisal of change and minimal clinically important difference on the European organization for the research and treatment of cancer quality of life questionnaire core 30 before and during cancer therapy. BMC Cancer. 2013 Mar 28;13:165. doi: 10.1186/1471-2407-13-165.
Other Identifiers
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08-284
Identifier Type: -
Identifier Source: org_study_id
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