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

NCT01308775 | Completed

• 1 other identifier: CC077515
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

SIS.NET

Outcome Measures

Primary Outcomes (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

  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.

  18 months

Secondary Outcomes (2)

• 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.

  18 months

• 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.

  18 months

Study Arms (1)

SIS.NET, Routine Follow up

ACTIVE COMPARATOR

Behavioral: SIS.NET, Routine Follow-up

Interventions

SIS.NET, Routine Follow-up BEHAVIORAL

* 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.

SIS.NET, Routine Follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have recovered from all serious side effects of acute phase of treatment for breast cancer.
• Patients must be willing to complete symptom reporting questionnaires at the intervals assigned by their care group.
• Patients must have hematologic, cardiac, hepatic, and renal function that are back to their pre-treatment values.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94105, United States

Location

Related Publications (1)

• Wheelock AE, Bock MA, Martin EL, Hwang J, Ernest ML, Rugo HS, Esserman LJ, Melisko ME. SIS.NET: a randomized controlled trial evaluating a web-based system for symptom management after treatment of breast cancer. Cancer. 2015 Mar 15;121(6):893-9. doi: 10.1002/cncr.29088. Epub 2014 Dec 2.

  PMID: 25469673 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michelle Melisko, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: March 4, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

US (1)