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

Breast Carcinoma Clinical Trial

Official title:

PatientCareAnywhere: Patient Support and Empowerment Across the Care Continuum

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02408406
• Other study ID #: 15025
• Secondary ID: NCI-2015-0055411
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2015
• Est. completion date: June 4, 2024

Study information

• Verified date: January 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 584
• Est. completion date: June 4, 2024
• Est. primary completion date: June 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Carcinoma
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Genital Neoplasms, Female
• Lung Carcinoma
• Malignant Female Reproductive System Neoplasm
• Malignant Neoplasm
• Neoplasms
• Urinary Bladder Neoplasms

Intervention

Other:
• Communication Intervention
Use PatientCareAnywhere system
• Educational Intervention
Use PatientCareAnywhere system
• Internet-Based Intervention
Use PatientCareAnywhere system
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Individual patient changes in Functional Assessment of Cancer Therapy-General (FACT-G) total scores	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
Primary	Functional Assessment of Cancer Therapy-General (FACT-G) scores	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	Change in self-efficacy as measured by the revised Chronic Disease Self-Efficacy Scale	Analysis steps follow those for the primary outcome.	Baseline to up to 6 months
Secondary	Change in health resource utilization	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