Clinical trial NCT00578006: Internet-based System for Cancer Patients to Self-report Toxicity
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lung Cancer
Prostate Cancer
Vaginal Cancer
Ovarian Cancer
Breast Cancer
Bladder Cancer
Keywords: toxicity related symptoms
04-020
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: conclusion of study
measure: To evaluate the impact of STAR on clinical outcomes
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ethan Basch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.