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BRIEF TITLE: PatientCareAnywhere: Patient Support and Empowerment Across the Care Continuum

PatientCareAnywhere: Patient Support and Empowerment Across the Care Continuum


  • Org Study ID: 15025
  • Secondary ID: NCI-2015-00554,115352,15025,R44CA192588
  • NCT ID: NCT02408406
  • NCT Alias:
  • Sponsor: City of Hope Medical Center - Other
  • Source: City of Hope Medical Center

Brief Summary

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.

Detailed Description


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.

Overal Status Start Date Phase Study Type
Recruiting July 7, 2015 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Functional Assessment of Cancer Therapy-General (FACT-G) scores

Primary Outcome 1 - Time Frame: Up to 6 months

Condition:

  • Bladder Carcinoma
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Lung Carcinoma
  • Malignant Female Reproductive System Neoplasm
  • Malignant Neoplasm

Eligibility

Criteria:
Inclusion Criteria:

- PHASE I AIM 1 (STAKEHOLDER INPUT)

- PHASE I AIM 1: Malignant diagnosis in any cancer type at any stage

- PHASE I AIM 1: Receiving any type of cancer treatment

- PHASE I AIM 1: Life expectancy of at least six months

- PHASE I AIM 1: Current outpatient status

- PHASE I AIM 1: Fluent in English

- PHASE I AIM 1: Internet access at home

- PHASE I AIM 3.1 (EVALUATION STUDY)

- PHASE I AIM 3.1: Malignant diagnosis in any cancer type at any stage

- PHASE I AIM 3.1: Receiving any type of cancer treatment

- PHASE I AIM 3.1: Life expectancy of at least six months

- PHASE I AIM 3.1: Current outpatient status

- PHASE I AIM 3.1: Fluent in English

- PHASE I AIM 3.1: Internet access at home

- PHASE I AIM 3.2 (PILOT STUDY)

- PHASE I AIM 3.2: Malignant diagnosis in breast, gynecologic (GYN), genitourinary (GU)
cancer at any stage

- PHASE I AIM 3.2: Receiving surgery and/or chemotherapy treatment

- PHASE I AIM 3.2: Life expectancy of at least six months

- PHASE I AIM 3.2: Current outpatient status (participation will be suspended during
hospitalization)

- PHASE I AIM 3.2: Fluent in English

- PHASE I AIM 3.2: Internet access at home

- PHASE II AIM 2 (RANDOMIZED CONTROLLED TRIAL)

- PHASE II AIM 2: Malignant diagnosis of breast, lung, or colorectal cancer at any stage

- PHASE II AIM 2: Receiving any type of cancer treatment

- PHASE II AIM 2: Life expectancy of at least six months

- PHASE II AIM 2: Current medical oncology outpatient status (participation will be
suspended during hospitalization)

- PHASE II AIM 2: Fluent in English

- PHASE II AIM 2: Internet access at home

Exclusion Criteria:

- PHASE I AIM 1 (STAKEHOLDER INPUT) EXCLUSION

- PHASE I AIM 1: Clinical evidence of cognitive or psychological impairment

- PHASE I AIM 1: Prisoners and pregnant women

- PHASE I AIM 3.1 (EVALUATION STUDY) EXCLUSION

- PHASE I AIM 3.1: Clinical evidence of cognitive or psychological impairment

- PHASE I AIM 3.1: Prisoners and pregnant women

- PHASE I AIM 3.2 (PILOT STUDY) EXCLUSION

- PHASE I AIM 3.2: Clinical evidence of cognitive or psychological impairment

- PHASE I AIM 3.2: Prisoners and pregnant women

- PHASE I AIM 3.2: Currently participating in other psychosocial studies

- PHASE II AIM 2 (RANDOMIZED CONTROLLED TRIAL) EXCLUSION

- PHASE II AIM 2: Clinical evidence of cognitive or psychological impairment

- PHASE II AIM 2: Prisoners and pregnant women

- PHASE II AIM 2: Currently participating in other psychosocial studies
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Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Official Information

Name: Matthew Loscalzo

Role: Principal Investigator

Affiliation: City of Hope Medical Center

Location

Facility Status Contact
City of Hope Medical Center
Duarte, California 91010
United States
Recruiting Matthew Loscalzo
800-826-4673