Breast Cancer Clinical Trial
Official title:
Pilot Study of STAR, an Internet-based System for Cancer Patients to Self-report Toxicity Symptoms, Performance Status, and Quality of Life
Cancer patients may develop side effects during treatment, such as nausea, pain, fatigue,
diarrhea, constipation, or shortness of breath. These symptoms may be due to the cancer
itself, or due to treatments like chemotherapy drugs or radiation therapy. Doctors and
nurses often ask patients about their symptoms, because an important part of cancer
treatment is to make patients feel as well as possible. If patients do not feel well, the
investigators may need to change the way the investigators are treating you or prescribe
therapies that will decrease your symptoms. The best way to find out how you are feeling is
to ask you directly.
However, during your time between appointments the investigators may not be able to ask you
how you are feeling on a regular basis. In addition, even at an appointment, there may be
symptoms that the investigators do not have a chance to discuss.
The investigators are interested in developing new ways to ask patients about how they are
feeling, using the Internet. A special new website called STAR ("Symptom Tracking and
Reporting for Patients") has been developed to help patients record this information, so
that their doctors and nurses can review it during clinic appointments. This study is
designed to help us see if STAR is a helpful way for us to keep track of information about
patients' symptoms and quality of life.
This pilot study will assess patient use of STAR (Symptom Tracking and Reporting for Patients), an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events v3.0, performance status by ECOG criteria, global quality of life by the EuroQOL 5-D assessment tool, emergency room visits, and survival. Secondary outcomes will include patient assessment of the usefulness of STAR, clinician perceptions of the potential value of STAR in routine clinical practice, and an evaluation of whether STAR improves the patient experience of care as assessed by satisfaction measures. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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