PatientCareAnywhere Internet-Based Software in Improving Communication and Education in Patients With Cancer and Their Healthcare Providers
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 8/18/2018 |
| Start Date: | July 2015 |
| End Date: | February 2019 |
PatientCareAnywhere: Patient Support and Empowerment Across the Care Continuum
This partially randomized pilot clinical trial develops and studies a software program,
called PatientCareAnywhere, to see whether it can help patients communicate with their
doctors and other healthcare providers, and educate themselves about their cancer and
treatment options. A program that can help patients learn about their cancer and treatment
options, and allows the patient's healthcare providers to receive their questionnaire
results, may help patients identify and get help to treat their symptoms.
called PatientCareAnywhere, to see whether it can help patients communicate with their
doctors and other healthcare providers, and educate themselves about their cancer and
treatment options. A program that can help patients learn about their cancer and treatment
options, and allows the patient's healthcare providers to receive their questionnaire
results, may help patients identify and get help to treat their symptoms.
PRIMARY OBJECTIVES:
I. Solicit stakeholder feedback on expected system functions, perceived usefulness and
impacts, and potential adoption barriers via 10 focus groups. (Human Subjects [HS], Phase I)
II. Develop the software prototype using an iterative user-centered design process and
leverage the technical design and components from an existing clinic-based biopsychosocial
screening tool and an existing patient portal solution as well as the patient education
contents from City of Hope (COH). (Phase I) III. Conduct two usability tests with 24 subjects
each to evaluate the usability, usefulness, and acceptability of the prototype system
developed in Aim 2. (HS, Phase I) IV. Conduct a 50-subject pilot evaluation study to
demonstrate the feasibility of our technical solution and our Phase II randomized controlled
trial protocol design. (HS, Phase I) V. Enhance the software system to add more
administrative/customization features and to expand the education contents to cover more
cancer types and treatment options. (Phase II) VI. Conduct a 2-year 516-subject randomized
control trial to test the effectiveness hypothesis. (HS, Phase II)
OUTLINE:
FOCUS GROUPS: Ten, 90-minute focus group sessions are conducted, composed of patients;
caregivers, friends, and family members; cancer treatment professionals; supportive care
professionals and community support professionals. Sessions address what functions
participants expect to see in the program, what benefits are expected, and any expected
barriers for using the program.
USABILITY EVALUATION (DESIGN-ORIENTED & METRIC-ORIENTED): Patients, caregivers, and clinical
care/support professionals in each type of evaluation undergo a 60-minute one-on-one session
in which they are assigned tasks to complete using the system, and an observer records how
the tasks are completed. Participants are also requested to talk aloud while performing the
task. Participants in the metric-oriented evaluation respond to usability and usefulness
questionnaires.
PILOT STUDY & RANDOMIZED CONTROLLED TRIAL: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION GROUP): Patients are encouraged to use the PatientCareAnywhere program at
least once weekly either in the clinic or at home. Patients receive reminder emails after 1
week of inactivity. If patients indicate they are experiencing moderate to severe symptoms,
an alert message is sent to at least 1 member of the patient's support team along with a list
of expected response times.
ARM II (CONTROL GROUP): Patients receive usual care, including a one-time use of
SupportScreen, a touchscreen questionnaire system that identifies patient issues before
appointments, at the clinic during the first treatment consultation after diagnosis.
Consultation, printed education materials, and specialist referrals may be generated based on
SupportScreen responses.
I. Solicit stakeholder feedback on expected system functions, perceived usefulness and
impacts, and potential adoption barriers via 10 focus groups. (Human Subjects [HS], Phase I)
II. Develop the software prototype using an iterative user-centered design process and
leverage the technical design and components from an existing clinic-based biopsychosocial
screening tool and an existing patient portal solution as well as the patient education
contents from City of Hope (COH). (Phase I) III. Conduct two usability tests with 24 subjects
each to evaluate the usability, usefulness, and acceptability of the prototype system
developed in Aim 2. (HS, Phase I) IV. Conduct a 50-subject pilot evaluation study to
demonstrate the feasibility of our technical solution and our Phase II randomized controlled
trial protocol design. (HS, Phase I) V. Enhance the software system to add more
administrative/customization features and to expand the education contents to cover more
cancer types and treatment options. (Phase II) VI. Conduct a 2-year 516-subject randomized
control trial to test the effectiveness hypothesis. (HS, Phase II)
OUTLINE:
FOCUS GROUPS: Ten, 90-minute focus group sessions are conducted, composed of patients;
caregivers, friends, and family members; cancer treatment professionals; supportive care
professionals and community support professionals. Sessions address what functions
participants expect to see in the program, what benefits are expected, and any expected
barriers for using the program.
USABILITY EVALUATION (DESIGN-ORIENTED & METRIC-ORIENTED): Patients, caregivers, and clinical
care/support professionals in each type of evaluation undergo a 60-minute one-on-one session
in which they are assigned tasks to complete using the system, and an observer records how
the tasks are completed. Participants are also requested to talk aloud while performing the
task. Participants in the metric-oriented evaluation respond to usability and usefulness
questionnaires.
PILOT STUDY & RANDOMIZED CONTROLLED TRIAL: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION GROUP): Patients are encouraged to use the PatientCareAnywhere program at
least once weekly either in the clinic or at home. Patients receive reminder emails after 1
week of inactivity. If patients indicate they are experiencing moderate to severe symptoms,
an alert message is sent to at least 1 member of the patient's support team along with a list
of expected response times.
ARM II (CONTROL GROUP): Patients receive usual care, including a one-time use of
SupportScreen, a touchscreen questionnaire system that identifies patient issues before
appointments, at the clinic during the first treatment consultation after diagnosis.
Consultation, printed education materials, and specialist referrals may be generated based on
SupportScreen responses.
Inclusion Criteria:
Stakeholder and Usability Study:
- Malignant diagnosis in any cancer type at any stage
- Receiving any type of cancer treatment
- Life expectancy of at least six months
- Current outpatient status
- Fluent in English
- Internet access at home
Pilot Study:
- Malignant diagnosis in breast, gynecologic (GYN), genitourinary (GU) cancer at any
stage
- Receiving surgery and/or chemotherapy treatment
- Life expectancy of at least six months
- Current outpatient status (participation will be suspended during hospitalization)
- Fluent in English
- Internet access at home
Randomized Controlled Trial:
- Malignant diagnosis of breast, lung or colorectal cancer at any stage
- Receiving any type of cancer treatment
- Life expectancy of at least six months
- Current medical oncology outpatient status (participation will be suspended during
hospitalization)
- Fluent in English
- Internet access at home
Exclusion Criteria:
Stakeholder and Usability Study:
- Clinical evidence of cognitive or psychological impairment
- Prisoners
- Pregnant women
Pilot Study and Randomized Controlled Trial:
- Clinical evidence of cognitive or psychological impairment
- Prisoners
- Pregnant women
- Currently participating in other psychosocial studies
We found this trial at
1
site
Duarte, California 91010
Principal Investigator: Matthew Loscalzo
Phone: 800-826-4673
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