Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02408406
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase N/A
Start date July 7, 2015
Completion date June 4, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04996316 - MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
Enrolling by invitation NCT05558917 - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery N/A
Completed NCT05526872 - A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening N/A
Not yet recruiting NCT05178498 - Impact of Dietary Inflammatory Potential on Breast Cancer Risk
Recruiting NCT05544123 - The Treatment Situation of Chinese County Population With Breast Cancer
Withdrawn NCT05191004 - Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC Phase 1/Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Recruiting NCT01462903 - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors Phase 1
Completed NCT01422408 - Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy Phase 2
Terminated NCT00770354 - Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer Phase 2
Terminated NCT02810873 - Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer N/A
Withdrawn NCT03185871 - Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses Phase 2
Completed NCT02983279 - Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer N/A
Active, not recruiting NCT02194387 - Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members N/A
Recruiting NCT05406232 - Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Recruiting NCT03408353 - Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
Completed NCT01641068 - Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms N/A
Withdrawn NCT04190433 - Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial Phase 2
Recruiting NCT04799535 - Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A