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Comparing (SIS.NET) to Standard Care in Patients Who Have Completed the Acute Phase of Treatment for Early Breast Cancer (CC077515)

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ClinicalTrials.gov Identifier: NCT01308775
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a pilot study that will compare two systems of breast cancer follow up care and will evaluate a number of parameters indicating quality and efficiency of care delivery as well as patient satisfaction with care. Approximately 100 breast cancer patients who have completed the acute phase of treatment will be randomized to one of two follow up care plans.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: SIS.NET, Routine Follow-up

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study Comparing a Patient-Centered Symptom Reporting Follow Up Program (SIS.NET) to Standard Care in Patients Who Have Completed the Acute Phase of Treatment for Early Breast Cancer
Study Start Date : January 2011
Primary Completion Date : March 2014
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: SIS.NET, Routine Follow up Behavioral: SIS.NET, Routine Follow-up
  • SIS.NET - One or two oncology related clinic visits per year (as recommended by the American Society of Clinical Oncology breast cancer follow up guidelines (18)), with additional access to oncology care driven by ongoing review of patient's self reported symptoms through web-based questionnaires.
  • Routine follow up care with appointment frequency determined by the treating medical oncologist or oncology/breast surgeon. Patients complete the same web-based symptom questionnaires within 30 days of a scheduled clinic visit but the results are not reviewed until their clinic visit.


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the time to evaluation of breast cancer or breast cancer treatment-related symptoms, between patients enrolled in a system of symptom-based, patient centered follow-up care (SIS.NET) and patients receiving standard follow up care [ Time Frame: 18 months ]
    This aim will determine which follow up care system provides more timely assessment and management of patient reported symptoms. Currently, patients may wait up to 2 weeks or more to be seen in clinic if they experience a new symptom in between regularly scheduled appointments. Our goal is to assess a patient's newly reported symptom in 3 business days or less.


Secondary Outcome Measures :
  1. To compare the number of oncology and primary care provider clinic visits, other subspecialty clinic visits, emergency room visits and phone calls to oncology related health care providers and triage nurses. [ Time Frame: 18 months ]
    To compare the number of oncology and primary care provider clinic visits, other subspecialty clinic visits, emergency room visits, and phone calls to oncology related health care providers and triage nurses between patients in SIS.NET vs. standard follow-up care.

  2. To compare the number of breast cancer and breast cancer treatment related diagnostic tests between patients enrolled in a computerized system and patients receiving standard follow up care. [ Time Frame: 18 months ]
    To compare the number of breast cancer or breast cancer treatment related diagnostic tests. Current ASCO follow up guidelines do not recommend the use of routine laboratory tests, tumor markers, or radiologic examinations (other than annual mammograms) for breast cancer follow up.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed with Stage I to Stage III breast cancer that have completed their acute phase of treatment. (This includes surgery, radiation, chemotherapy, or any experimental therapies offered in a clinical trial as adjuvant treatment.)

    • Patients who received chemotherapy must be 6 months out from completion of chemotherapy.
    • For patients who receive adjuvant hormonal therapy (with or without prior chemotherapy), patients must be 3 months out from initiation of hormonal therapy.
    • For patients who do not receive adjuvant chemotherapy or hormonal therapy, patients must be 3 months out from surgery and radiation therapy.
  2. Patients must have recovered from all serious side effects of acute phase of treatment for breast cancer.
  3. Patients must be willing to complete symptom reporting questionnaires at the intervals assigned by their care group.
  4. Patients must have hematologic, cardiac, hepatic, and renal function that are back to their pre-treatment values.
  5. Patient must be able to read and speak English sufficiently to complete symptom reporting questionnaires and discuss details of symptoms and health status over the telephone.
  6. Patient must have access to a computer on which to complete the on-line surveys or must be willing to come to the UCSF Cancer Resource Center to complete questionnaires at the intervals assigned by their care group.

Exclusion Criteria:

  1. History of severe depression or an anxiety disorder that is felt to interfere with a patient's ability to accurately self-report symptoms.
  2. Complications from breast surgery or reconstruction, or from chemotherapy or radiation that may require regular ongoing clinic visits for physical and/or laboratory evaluation.

Contacts and Locations

Information from the National Library of Medicine

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): NCT01308775


Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94105
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Michelle Melisko, M.D. University of California, San Francisco
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01308775     History of Changes
Other Study ID Numbers: CC077515
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015

Keywords provided by University of California, San Francisco:
SIS.NET

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases