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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michelle Melisko, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01308775
First received: February 24, 2011
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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 Intervention
Breast Cancer
Behavioral: SIS.NET, Routine Follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michelle Melisko, Associate Clinical Professor, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01308775     History of Changes
Other Study ID Numbers: CC077515
Study First Received: February 24, 2011
Last Updated: June 25, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 19, 2014