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

June 26, 2024 updated by: City of Hope Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy-General (FACT-G) scores
Time Frame: 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.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-efficacy as measured by the revised Chronic Disease Self-Efficacy Scale
Time Frame: Baseline to up to 6 months
Analysis steps follow those for the primary outcome.
Baseline to up to 6 months
Change in health resource utilization
Time Frame: 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.
Baseline to up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual patient changes in Functional Assessment of Cancer Therapy-General (FACT-G) total scores
Time Frame: 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.
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen Clark, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2015

Primary Completion (Actual)

June 19, 2024

Study Completion (Actual)

June 19, 2024

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimated)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15025 (Other Identifier: City of Hope Comprehensive Cancer Center)
  • NCI-2015-00554 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 115352
  • R44CA192588 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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