Computerized Assessment for Patients With Cancer (ESRA-C_II)
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|ClinicalTrials.gov Identifier: NCT00852852|
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Electronic Self-Report Assessment - Cancer (ESRA-C)||Not Applicable|
- This study includes two groups of participants: 1) Clinician Participants and 2) Patient Participants.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||779 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Computerized Assessment for Patients With Cancer-ESRA-C II|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||December 2013|
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.
Behavioral: 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.
No Intervention: Control
Participants in the control arm access the ESRA-C from home or clinic to self-assess only.
- Symptom burden and quality of life 2-4 weeks post treatment [ Time Frame: 3 years ]
- To assess the feasibility of delivering a patient oriented, patient-controlled ESRA-C directly to patients outside clinically settings. [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852852
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98115|
|Principal Investigator:||Donna L. Berry||Dana-Farber Cancer Institute|