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

NCT02408406 | Completed DMC

• 4 other identifiers: 15025NCI-2015-00554115352R44CA192588
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in self-efficacy as measured by the revised Chronic Disease Self-Efficacy Scale

  Baseline to up to 6 months

• Change in health resource utilization

  Baseline to up to 6 months

Other Outcomes (1)

• Individual patient changes in Functional Assessment of Cancer Therapy-General (FACT-G) total scores

  Baseline to 3 months

Study Arms (2)

Arm I (PatientCareAnywhere program system)

EXPERIMENTAL

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; Other: Educational Intervention; Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

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; Other: Questionnaire Administration

Interventions

Communication Intervention OTHER

Use PatientCareAnywhere system

Arm I (PatientCareAnywhere program system)

Educational Intervention OTHER

Use PatientCareAnywhere system

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm I (PatientCareAnywhere program system)

Internet-Based Intervention OTHER

Use PatientCareAnywhere system

Arm I (PatientCareAnywhere program system)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (PatientCareAnywhere program system); Arm II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (PatientCareAnywhere program system); Arm II (usual care)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• PHASE I AIM 1: Clinical evidence of cognitive or psychological impairment
• PHASE I AIM 1: Prisoners and pregnant women
• 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: 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: 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

Sponsors & Collaborators

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

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

• Baik SH, Clark K, Sanchez M, Loscalzo M, Celis A, Razavi M, Yang D, Dale W, Haas N. Usability and Preliminary Efficacy of an Adaptive Supportive Care System for Patients With Cancer: Pilot Randomized Controlled Trial. JMIR Cancer. 2024 Jul 10;10:e49703. doi: 10.2196/49703.

  PMID: 38986134 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Karen Clark

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: July 7, 2015
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

US (1)