Clinical trial · Interventional
Comparing (SIS.NET) to Standard Care in Patients Who Have Completed the Acute Phase of Treatment for Early Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIS.NET, Routine Follow-up | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- SIS.NET, Routine Follow up
- interventionNames
- Behavioral: SIS.NET, Routine Follow-up
Primary outcomes (1)
- 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
- timeFrame
- 18 months
- 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.
Secondary outcomes (2)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. \-
References
Publications (1)
- DERIVEDWheelock 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