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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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

Over 200,000 women were diagnosed with breast cancer in the year 2006. Many of these women
will be rendered free of cancer, but will need ongoing disease specific care and
surveillance. The estimated number of breast cancer survivors in the year 2003 was 2.3
million (1). With outcomes improving after the diagnosis of early breast cancer, the number
of breast cancer survivors in follow up care will continue to increase and eventually result
in an unmanageable load on the subspecialties of medical and surgical oncology. Most of
these patients continue to be seen by an oncology specialist for at least five years after
their cancer diagnosis, but this type of follow up may not be necessary or optimally

Alternate Strategies for Health Care Delivery Studies suggest that oncology follow up care
is costly to the health care system no matter who the provider is, and in some cases,
diagnostic tests are overused (2). In a randomized trial of 296 women with a history of
breast cancer in Great Britain, transfer of routine follow-up care to a family physician did
not result in an increase in the time to diagnosis of recurrence (3). Patient satisfaction
was greater and health service costs were less, and anxiety and health related quality of
life were unaffected (4, 5). A similar multicenter trial of 968 early-stage breast cancer
patients in Canada who had completed adjuvant treatment randomized patients to follow up in
a cancer center or with their own family physician (6). This study found no statistically
significant differences in number of recurrences, deaths, recurrence related serious
clinical events, or patient reported health-related quality of life questionnaires between
the groups. While transferring oncology follow-up care back to primary care physicians seems
a reasonable alternative, the shortage of primary care physicians in certain regions of the
US and around the world, limits this approach (7, 8). A study in Sweden compared nurse-led
follow-up vs. physician follow-up in 264 consecutively selected women with newly diagnosed
Stage I or II breast cancer (9). Outcomes included measures of patient well-being,
satisfaction, access to medical care, and medical safety. Questionnaires containing the
Hospital Anxiety and Depression Scale (HADS), and the Satisfaction and Accessibility (SaaC)
scale were obtained at baseline and twice a year over a period of 5 years. Number of
contacts with health care services, number of diagnostic procedures, and time to recurrence
or death were monitored. Ratings of HADS and SaaC scales did not show any statistically
significant differences between the follow-up groups. The levels of anxiety and depression
were generally low, and levels of patient satisfaction high. There were no differences
between the groups concerning time to recurrence or death suggesting that follow-up care
with an experienced nurse professional is safe and effective.

Various strategies have been studied to evaluate alternatives to routine clinic visits and
referrals to subspecialists in order to improve access to care and to lower health care
costs. One such study tested the hypotheses that virtual outreach would reduce number of
contacts with the health care system, reduce the number of medical tests and interventions,
and have a positive impact on patient satisfaction. A randomized controlled trial was
conducted which compared standard outpatient referral to joint teleconsultations between
general practitioners (GP), specialists, and patients (10). Patients randomized to virtual
outreach underwent a joint teleconsultation, in which they and their GP consulted with a
hospital specialist via a videolink. In this study, patients in the virtual outreach group
were more likely to be scheduled for a follow-up appointment, but fewer tests and
investigations were ordered. In the 6-month period following the initial consultation, there
were no significant differences in number of contacts or outpatient visits with GP,
inpatient stays, procedures, or prescriptions between the randomized groups. Patient
satisfaction was greater after a virtual outreach consultation, and patient enablement and
the physical and psychological scores of the Short Form-12, did not differ between the
randomized groups. Interestingly, health care costs over 6 months were greater for the
virtual outreach consultations than for conventional outpatients, but overall cost, time,
and productivity savings to patients were identified. This study represents an example of
how technology can be utilized to streamline care and provide more patient centered
services, but that these services may not save money overall in the health care system. The
need to assess the cost-effectiveness and patient outcomes of alternate surveillance and
follow up strategies was recently highlighted in a review article by Tolaney (11).

UCSF and Dynamic Clinical Systems (DCS) Collaboration The UCSF Breast Care Center has
embarked upon collaboration with Dynamic Clinic Systems to implement a computer based,
patient centered system of symptom reporting and data collection to improve clinical care to
our patients and generate databases of patient reported symptoms and outcomes information
for research purposes. Dynamic Clinical Systems (DCS) is a provider of real-time Web-based
applications focusing on the patient-clinician interaction. The DCS approach enables
patients to provide health data electronically. Clinicians may use this data for research,
medical documentation, and registries depending on the type of data collected and the
consent of the patient.

Through this system, patients will report their own health information via the DCS web-based
Integrated Survey System (ISS). The process is as follows: A real-time interface downloads
appointments from the hospital scheduling system into ISS. Survey groups are automatically
scheduled based on pre-defined timing parameters. Prior to sending the patient their first
survey, each patient will be called and welcomed to the program and asked if they use the
internet. If they do, they will be given instructions for completion of surveys at home. If
they need assistance, they will be given an appointment to come to our resource center and
work with our staff member to complete the survey. The patient will be notified (via
automatically-generated email from ISS or hospital letter/phone) to either sign on and take
the survey from home or come to clinic early to take the survey. Once logged in, the patient
has the opportunity to indicate online consent (to be approved by CHR) to share data for
research purposes. An analyst will monitor the progress of survey completion and will call
any patient whose surveys are not complete prior to their clinic appointment to facilitate
survey completion. At the end of the process, a patient summary report is generated in ISS
displaying a summary of patient survey answers, longitudinal comparisons of previous
surveys, red flags and warnings, and quality measures. The clinician uses this report during
the clinic visit to focus the discussion on highlighted items.

DCS is a service vendor who has built and who services the online-questionnaire platform.
All content in the questionnaires has been created and reviewed by the investigators at UCSF
(with the exception of standardized surveys such as the SF-36 and other validated
questionnaires). Other than this, the DCS has no role in this study, and it does not
receive or have access to information regarding study outcomes (such as in terms of patient
visits or interventions) from either arm of the study.

We plan to implement and evaluate a comprehensive survivorship program, supported by this
interactive web-based system for reporting physical and psychological symptoms. The system
will capture structured data that then can be used to drive translation of research findings
to improve care for survivors. The System for Individualized survivorship care, based on
patient Self-reported data, with review by Nurse practitioners, targeted Education, and
Triage to appropriate services to improve symptom management and outcomes will be called

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

- For patients who receive adjuvant hormonal therapy (with or without prior
chemotherapy), patients must be 3 months out from initiation of hormonal

- 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

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.


Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Michelle Melisko, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Institutional Review Board

Study ID:




Start Date:

January 2011

Completion Date:

March 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115