Computerized Assessment for Patients With Cancer

Study Overview
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Brief Summary
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This research study will test a new online computer program for patients, the Electronic Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and quality of life issues and learn information about how to deal with these experiences. The computer program is being tested to see if it can improve communications between patients and their care team and if it can improve patients' experiences during and after treatment.

Detailed Description
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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.

Official Title
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Computerized Assessment for Patients With Cancer-ESRA-C II

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Electronic Self-Report Assessment - Cancer (ESRA-C)


Participation Criteria
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Eligibility Criteria
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Eligible clinician participants (Inclusion): Nurses, physicians, or physician assistants 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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)<br>* 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.<br>|
| No Intervention: Control<br>Participants in the control arm access the ESRA-C from home or clinic to self-assess only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden and quality of life 2-4 weeks post treatment |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of delivering a patient oriented, patient-controlled ESRA-C directly to patients outside clinically settings. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRA-C 2, computerized assessment