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| Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00578006 |
Purpose
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, we may need to change the way we 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 we 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 we do not have a chance to discuss.
We 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 | Intervention |
|---|---|
|
Cervical Cancer Lung Cancer Prostate Cancer Vaginal Cancer Ovarian Cancer Breast Cancer Bladder Cancer |
Behavioral: Questioners Behavioral: STAR website |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Pilot Study of STAR, an Internet-Based System for Cancer Patients to Self-Report Toxicity Symptoms, Performance Status, and Quality of Life |
| Estimated Enrollment: | 800 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
If you are in group A, we 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
We 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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B
If you are in group B, we 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. We will 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.
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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, and global quality of life by the EuroQOL 5-D assessment tool. 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 quality of life and satisfaction measures.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
MSKCC outpatient clinics
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ethan Basch, MD | 646-422-4426 | basche@mskcc.org |
| Contact: Elena Elkin, PhD | 646-735-8141 | elkine@mskcc.org |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Ethan Basch, MD 646-735-8154 basche@mskcc.org | |
| Contact: Elena Elkin, PhD 646-735-8141 elkine@mskcc.org | |
| Principal Investigator: Ethan Basch, MD | |
| Principal Investigator: | Ethan Basch, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Ethan Basch, MD ) |
| Study ID Numbers: | 04-020 |
| Study First Received: | December 18, 2007 |
| Last Updated: | June 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00578006 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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toxicity related symptoms |
|
Thoracic Neoplasms Urinary Tract Neoplasm Genital Neoplasms, Male Prostatic Diseases Gonadal Disorders Vaginal Cancer Quality of Life Vaginal Diseases Urogenital Neoplasms Ovarian Diseases Urologic Neoplasms Genital Diseases, Female Urologic Diseases Respiratory Tract Diseases Lung Neoplasms |
Ovarian Cancer Bladder Neoplasm Breast Diseases Endocrine Gland Neoplasms Vaginal Neoplasms Cystocele Ovarian Neoplasms Skin Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Lung Diseases |
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Thoracic Neoplasms Prostatic Diseases Genital Neoplasms, Male Gonadal Disorders Vaginal Diseases Urogenital Neoplasms Ovarian Diseases Urologic Neoplasms Genital Diseases, Female Neoplasms by Site Urologic Diseases Respiratory Tract Diseases Lung Neoplasms Breast Diseases Endocrine Gland Neoplasms |
Vaginal Neoplasms Respiratory Tract Neoplasms Ovarian Neoplasms Skin Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Adnexal Diseases Neoplasms Lung Diseases Prostatic Neoplasms |
