Internet-based System for Cancer Patients to Self-report Toxicity
Pilot Study of STAR, an Internet-based System for Cancer Patients to Self-report Toxicity Symptoms, Performance Status, and Quality of Life
1 other identifier
interventional
1,007
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 18, 2007
CompletedFirst Posted
Study publicly available on registry
December 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 10, 2017
January 1, 2017
12.8 years
December 18, 2007
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
conclusion of study
To evaluate the impact of STAR on clinical outcomes
2 years
Secondary Outcomes (1)
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.
conclusion of study
Study Arms (2)
A
EXPERIMENTALIf 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.
B
EXPERIMENTALIf 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.
Interventions
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.
You can report your symptoms every time you come to Sloan-Kettering for an appointment or chemotherapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- ECOG performance status greater than 2
- Unable to read and comprehend English language text
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
PMID: 26644527DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ethan Basch, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2007
First Posted
December 20, 2007
Study Start
March 1, 2004
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
January 10, 2017
Record last verified: 2017-01