PatientCareAnywhere Internet-Based Software in Improving Communication and Education in Patients With Cancer and Their Healthcare Providers

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02408406
Collaborator
National Cancer Institute (NCI) (NIH)
584
1
2
94.9
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Communication Intervention
  • Other: Educational Intervention
  • Other: Internet-Based Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Solicit stakeholder feedback on expected system functions, perceived usefulness and impacts, and potential adoption barriers via 10 focus groups. (Human Subjects [HS], Phase I)
  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
584 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
PatientCareAnywhere: Patient Support and Empowerment Across the Care Continuum
Actual Study Start Date :
Jul 7, 2015
Anticipated Primary Completion Date :
Jun 4, 2023
Anticipated Study Completion Date :
Jun 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (PatientCareAnywhere program system)

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.

Other: Communication Intervention
Use PatientCareAnywhere system

Other: Educational Intervention
Use PatientCareAnywhere system
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
  • Other: Internet-Based Intervention
    Use PatientCareAnywhere system

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Active Comparator: Arm II (usual care)

    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.

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Functional Assessment of Cancer Therapy-General (FACT-G) scores [Up to 6 months]

      Separate analysis will be carried out for the per-protocol (PP) population and intent-to-treat (ITT) population. For the PP population, a repeated measures analysis of variance will be employed. In this model, FACT-G scores are the response variables. Time, patient group and their interaction are the predictors. For the ITT population, a random effect model will be fitted to the data. The model can also adjust for covariates of potential interests. Exploratory assessments may also include effects of other variables of interest, such as demographic and baseline values.

    Secondary Outcome Measures

    1. Change in self-efficacy as measured by the revised Chronic Disease Self-Efficacy Scale [Baseline to up to 6 months]

      Analysis steps follow those for the primary outcome.

    2. Change in health resource utilization [Baseline to up to 6 months]

      Measured by number of unplanned hospitalizations, emergency room visits, intensive care unit stays, diagnostic tests, and clinic no-shows. Analysis steps follow those for the primary outcome.

    Other Outcome Measures

    1. Individual patient changes in Functional Assessment of Cancer Therapy-General (FACT-G) total scores [Baseline to 3 months]

      Categorized as improved (+ 10% or higher compared to baseline), unchanged (-9.9% to +9.9%), or declined (- 10% or lower compared to baseline). Missing data will be accounted for using the last-observation-carried-forward value. The proportion of patients in each category will be calculated per patient group. Differences in category proportions per patient group will be investigated via ordinal logistic regression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Matthew Loscalzo, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT02408406
    Other Study ID Numbers:
    • 15025
    • NCI-2015-00554
    • 115352
    • 15025
    • R44CA192588
    First Posted:
    Apr 3, 2015
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022

    Study Results

    No Results Posted as of Feb 21, 2022