Breast Cancer Clinical Trial
Official title:
Pilot Project to Better Understand Non-Clinical Needs of Cancer Patients
Verified date | April 2019 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Stanford Cancer Center is undertaking a Transformation Initiative in order to improve the quality of care and care coordination across the continuum of care. The newest innovation is to introduce lay navigators to specified high-need patients. The larger goal of the project is to assess whether lay navigators can address non-clinical patient needs in a timely fashion and appropriately connect them with their clinical team when warranted. It is expected that proactive interaction with patients will decrease patient anxiety/stress related to their cancer and facilitate higher patient engagement and improved management of physical, social,and emotional health. For the pilot project, the smaller goal is to understand: how lay navigator time is used; the types and frequency of issues brought up by patients; resources that patients are given or referred to; type and frequency of mode of contact with patients; and patients' acceptance of navigators based on refusal. An electronic intake form will be used to collect this information so that data can be analyzed regularly to inform changes to the navigator program as needed.
Status | Completed |
Enrollment | 1053 |
Est. completion date | December 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - New patient to eligible Cancer Care Program (CCP) - Biopsy positive - Plan to receive at least one treatment modality at Stanford: surgery, chemotherapy and/or radiation therapy - Cancer that is treated by any of the following CCPs: Breast, Gynecologic oncology, Head/neck, Cutaneous (melanoma only), Thoracic, Gastrointestinal - Patient has even numbered MRN Exclusion Criteria: - Anyone with odd numbered MRN - Anyone in other cancer programs that are not included - Biopsy negative - No treatment modality received - Patients with already established care/treatment i.e. not new patients |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Cancer Center | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Hennink MM, Kaiser BN, Marconi VC. Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough? Qual Health Res. 2017 Mar;27(4):591-608. doi: 10.1177/1049732316665344. Epub 2016 Sep 26. — View Citation
O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ. 2010 Sep 17;341:c4587. doi: 10.1136/bmj.c4587. — View Citation
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Experience/Satisfaction: Difference in topbox scores | Difference in topbox scores from apriori selected questions from the transformation evaluation in navigated vs not navigated patients. | 3-18 months after eligibility is determined | |
Primary | Rates of unplanned hospitalization and ER visits | Comparison of rates of unplanned hospitalizations and ER visits among eligible patients in the navigated group vs. un-navigated patients. | 0-18 months after eligibility is determined | |
Secondary | Utilization of non-treatment-related cancer services | Comparison of the proportion of navigated patients that used non-treatment-related cancer services to those not navigated. Examples of services include palliative care, supportive care, nutrition, etc. | 0-18 months after eligibility is determined |
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