Breast CancerNCT03245788
Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study
A study testing Lay Navigation in people with Breast Cancer and Gynecologic Cancer, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer, Neck Cancer
- What is being tested?
- Lay Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,053 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Project to Better Understand Non-Clinical Needs of Cancer Patients
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.
Read the detailed description
The Stanford Cancer Institute is undergoing a 5-year Transformation Initiative that began in 2013. One of the goals of this initiative is to increase patient engagement. The underlying premise is that engaged patients will be more likely to attend all their visits, receive all their treatments, and understand ways to manage treatment side effects so that they are less likely to go to the emergency room (ER) or be admitted to the hospital. An approach being tested is to use lay navigators to help identify patient issues and help them address the issues through a combination of direct supportive activities (e.g., calling clinical team for the patient) and activities that help the patients help themselves (helping them understand when side effects warrant a call to their clinical team that they make themselves).
Information including patient acceptance/refusal of navigator services; number and types of contacts with patients (phone, in-person, email); types of issues discussed (financial, social, educational, physical, emotional, etc); referrals made; and time spent with patients for each encounter will be routinely entered by the navigators for each patient contact. The data entered will be evaluated regularly to closely monitor navigator activities and better understand cancer patient issues/needs. This information will be used to inform possible training needs of navigators, educational needs of patients,needs for better referral support,help predict navigator case-load, and other issues.
Eligibility Criteria:
All new biopsy positive cancer patients that have a treatment plan to receive at least 2 treatment modalities: surgery, chemotherapy and/or radiation therapy at Stanford are eligible. Because there will be more patients eligible than the navigators can manage, only patients with an even MRN will receive a navigator for the pilot. The overall purpose of the pilot is to learn which patients benefit most and which services navigators are able to best help with. The investigators expect the pilot to last 6-12 months. Mixed methods will be used to evaluate the navigators and will include existing patient experience surveys, unscheduled hospitalizations, ER visits, interviews with patients, staff (including navigators), and physicians regarding their experience with and perceived value of navigators.
- Conditions
- Breast Cancer, Gynecologic Cancer, Neck Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Thoracic Cancer
- Being tested
- Lay Navigation
- Keywords
- Lay Navigator, Quality of Care, High-Need Cancer Treatment Regimen
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms, Skin Neoplasms, Urologic Neoplasms, Lymphoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lay NavigationOther
Patients who are assigned to intervention will be contacted by a navigator who will explain and offer their services to the patient. Navigators focus efforts on supporting patients in self-management and in supporting non-medical needs.
| Study group | Role | What they receive |
|---|---|---|
| Lay Navigation | Experimental | Patients with even MRN. Receives: Other: Lay Navigation |
| Usual Care | No intervention | Patients with odd MRN. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-18 months after eligibility is determined
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.
Measured: 0-18 months after eligibility is determined
Secondary outcomes (1)
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.
Measured: 0-18 months after eligibility is determined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start15 Feb 2017
- Primary completion31 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 12 groups in each arm which reflects the 12 different cancer types.
- Masking
- None (open label)
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcy Winget, Stanford University
- Investigators
- Steve Asch, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245788
- Sponsor's protocol ID
- 42674
- Status last verified
- Apr 2019
- First submitted
- 4 May 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27670770O'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. No abstract available.
PubMed 20851841Proctor 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.
PubMed 20957426Winget M, Holdsworth L, Wang S, Veruttipong D, Zionts D, Rosenthal EL, Asch SM. Effectiveness of a Lay Navigation Program in an Academic Cancer Center. JCO Oncol Pract. 2020 Jan;16(1):e75-e83. doi: 10.1200/JOP.19.00337. Epub 2019 Oct 24.
PubMed 31647691
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project to Better Understand Non-Clinical Needs of Cancer Patients
- ClinicalTrials.gov ID
- NCT03245788
- Acronym / sponsor ID
- 42674
- Conditions
- Breast Cancer, Gynecologic Cancer, Neck Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Thoracic Cancer
- Keywords
- Lay Navigator, Quality of Care, High-Need Cancer Treatment Regimen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Stanford Cancer Institute is undergoing a 5-year Transformation Initiative that began in 2013. One of the goals of this initiative is to increase patient engagement. The underlying premise is that engaged patients will be more likely to attend all their visits, receive all their treatments, and understand ways to manage treatment side effects so that they are less likely to go to the emergency room (ER) or be admitted to the hospital. An approach being tested is to use lay navigators to help identify patient issues and help them address the issues through a combination of direct supportive activities (e.g., calling clinical team for the patient) and activities that help the patients help themselves (helping them understand when side effects warrant a call to their clinical team that they make themselves).
Information including patient acceptance/refusal of navigator services; number and types of contacts with patients (phone, in-person, email); types of issues discussed (financial, social, educational, physical, emotional, etc); referrals made; and time spent with patients for each encounter will be routinely entered by the navigators for each patient contact. The data entered will be evaluated regularly to closely monitor navigator activities and better understand cancer patient issues/needs. This information will be used to inform possible training needs of navigators, educational needs of patients,needs for better referral support,help predict navigator case-load, and other issues.
Eligibility Criteria:
All new biopsy positive cancer patients that have a treatment plan to receive at least 2 treatment modalities: surgery, chemotherapy and/or radiation therapy at Stanford are eligible. Because there will be more patients eligible than the navigators can manage, only patients with an even MRN will receive a navigator for the pilot. The overall purpose of the pilot is to learn which patients benefit most and which services navigators are able to best help with. The investigators expect the pilot to last 6-12 months. Mixed methods will be used to evaluate the navigators and will include existing patient experience surveys, unscheduled hospitalizations, ER visits, interviews with patients, staff (including navigators), and physicians regarding their experience with and perceived value of navigators.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be 12 groups in each arm which reflects the 12 different cancer types.
| Arm | Type | Receives |
|---|---|---|
| Lay Navigation | Experimental | Other: Lay NavigationPatients with even MRN. |
| Usual Care | No intervention | –Patients with odd MRN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lay NavigationPatients who are assigned to intervention will be contacted by a navigator who will explain and offer their services to the patient. Navigators focus efforts on supporting patients in self-management and in supporting non-medical needs. | Other | Lay Navigation |
Primary outcome
Patient Experience/Satisfaction: Difference in topbox scores
Time frame: 3-18 months after eligibility is determined
Difference in topbox scores from apriori selected questions from the transformation evaluation in navigated vs not navigated patients.
Rates of unplanned hospitalization and ER visits
Time frame: 0-18 months after eligibility is determined
Comparison of rates of unplanned hospitalizations and ER visits among eligible patients in the navigated group vs. un-navigated patients.
1 secondary outcome
Utilization of non-treatment-related cancer services
Time frame: 0-18 months after eligibility is determined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Background: PubMed 27670770Hennink 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.
- Background: PubMed 20851841O'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. No abstract available.
- Background: PubMed 20957426Proctor 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.
- Derived from this study: PubMed 31647691Winget M, Holdsworth L, Wang S, Veruttipong D, Zionts D, Rosenthal EL, Asch SM. Effectiveness of a Lay Navigation Program in an Academic Cancer Center. JCO Oncol Pract. 2020 Jan;16(1):e75-e83. doi: 10.1200/JOP.19.00337. Epub 2019 Oct 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Asch, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lay Navigation in people with Breast Cancer and Gynecologic Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Experience/Satisfaction: Difference in topbox scores (time frame: 3-18 months after eligibility is determined). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245788, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.