Rectal Cancer Clinical Trial
Official title:
Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management
Verified date | December 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. This application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to enhance self-management of cancer and treatment-related symptoms. This study will examine patient acceptance and use of this mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive Cancer Center.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Diagnosed with colon or rectal cancer - Expected to live at least 6 months - Initiating chemotherapy for the first time in their treatment history - Physically and mentally able to participate - Able to read English - Willing and able to sign informed consent Exclusion Criteria: - A treatment plan that does not include cytotoxic chemotherapy for colon or rectal cancer - A medical history that includes cancer with the exception of in situ cancers of the cervix and basal cell cancers of the skin - A current diagnosis that includes multiple cancers (this does not exclude metastatic disease) - Received prior cytotoxic chemotherapy for any reason - A diagnosed psychiatric disorder |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | McKesson Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient retention and engagement with the MyChemoCare application | The investigators will record enrollment, drop-off and daily engagement with the MyChemoCare app. | 8 weeks post-enrollment | No |
Primary | Patient satisfaction and usability of the MyChemoCare application | The investigators will use a 10-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app. | 8 weeks post enrollment | No |
Secondary | Physician compliance to study protocol | The investigators will assess how often physicians in the study use feedback from the MyChemoCare application. | 8 weeks post-enrollment | No |
Secondary | Mastery of cancer and chemotherapy symptoms | The investigators will use the Cancer Care Mastery Scale to assess patients' feelings of control over their cancer care. | 8 weeks post enrollment | No |
Secondary | Symptom burden | The investigators will use the MD Anderson Symptom Inventory (MDASI) to describe patient experiences in 13 core symptom areas. | 8 weeks post enrollment | No |
Secondary | Quality of Life | The investigators will use the FACT-G survey to assess four dimensions of patients health (physical, functional, social and emotional). | Baseline and 8 weeks post enrollment | No |
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