Internet-based System for Cancer Patients to Self-report Toxicity
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ClinicalTrials.gov Identifier: NCT00578006 |
Recruitment Status :
Completed
First Posted : December 20, 2007
Last Update Posted : January 10, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
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Cervical Cancer Lung Cancer Prostate Cancer Vaginal Cancer Ovarian Cancer Breast Cancer Bladder Cancer | Behavioral: Questioners Behavioral: STAR website | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1007 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | Pilot Study of STAR, an Internet-based System for Cancer Patients to Self-report Toxicity Symptoms, Performance Status, and Quality of Life |
Study Start Date : | March 2004 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | January 2017 |

Arm | Intervention/treatment |
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Experimental: A
If you are in group A, the investigators will ask you to fill out a brief paper questionnaire periodically to tell us how you are feeling, and how satisfied you are with your care.
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Behavioral: Questioners
The investigators will ask you to fill out a brief paper questionnaire periodically to tell us how you are feeling, and how satisfied you are with your care. |
Experimental: B
If you are in group B, the investigators will provide you with access to the STAR website using a computer in the waiting area, into which you can report your symptoms every time you come to Sloan-Kettering for an appointment or chemotherapy. The investigators may also provide you with a website address so that you can access STAR from home (or any other location) to report your symptoms at any time.
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Behavioral: STAR website
You can report your symptoms every time you come to Sloan-Kettering for an appointment or chemotherapy. |
- To evaluate patient willingness to use STAR (Symptom Tracking and Reporting for Patients), an Internet-based system for cancer patients to self-report common toxicity symptoms, performance status, and quality of life. [ Time Frame: conclusion of study ]
- To evaluate the impact of STAR on clinical outcomes [ Time Frame: 2 years ]
- To measure patient assessments of the usefulness of STAR, and to measure clinician perceptions of the potential value of STAR in routine outpatient cancer care. [ Time Frame: conclusion of study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 years
- Diagnosis of gynecologic (ovarian; cervical; uterine; primary peritoneal), lung (non-small cell; small cell), gastrointestinal (colorectal, rectal, gastric, esophageal, GI neuroendocrine, small intestine malignancy, pancreatic, hepatocellular), breast, bladder cancer or prostate malignancy
- Receiving primary medical oncology care at MSKCC medical oncology outpatient clinics
- Receiving cytotoxic chemotherapy not on a clinical trial (or a new hormonal therapy in the case of prostate cancer patients only), with treatment expected to continue for at least four weeks from the time of enrollment
- Signed informed consent and Research Authorization
Exclusion Criteria:
- ECOG performance status greater than 2
- Unable to read and comprehend English language text

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578006
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Ethan Basch, MD | Memorial Sloan Kettering Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00578006 |
Other Study ID Numbers: |
04-020 |
First Posted: | December 20, 2007 Key Record Dates |
Last Update Posted: | January 10, 2017 |
Last Verified: | January 2017 |
toxicity related symptoms 04-020 |
Vaginal Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Neoplasms, Female Vaginal Diseases |