Internet-based System for Cancer Patients to Self-report Toxicity

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Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 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.

Condition

Cervical Cancer

Intervention

Questioners

Study Arms / Comparison Groups

 A
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

1007

Start Date

March 2004

Completion Date

January 2017

Primary Completion Date

January 2017

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ethan Basch, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00578006

Organization ID

04-020


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center


Study Sponsor

Ethan Basch, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

January 2017