Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

This cohort will download and use the Outcomes4Me mobile app for breast cancer.

A mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer

Outcomes4Me Mobile App

Amanda Stroiney

Maya Said, Sci.D

Steven Isakoff, MD

This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.

This protocol is a single arm pilot study of a novel breast cancer navigation app that is intended to assist patients with breast cancer understand their diagnosis and treatment options (both as part of standard of care practice and clinical trials) and manage their care, through treatment and symptom tracking. Patients will also be able to share information and get news via the app relevant to their cancer subtype. Results from this intervention will inform future clinical integration efforts, improve patient-centeredness of such an app-based health content and data platform, and inform the design of a larger, randomized study to demonstrate an improvement in patients' outcomes as well as enhanced Real-World Evidence (RWE) data collection.

Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients

We will track engagement with the app by tracking the number of times a user logs in to the Outcomes4Me app over a 12 week period. The app will be considered feasible if at least 40% of enrolled patients engage with the Outcomes4Me app at least 3 times during the 12-week study period.

Usability will be assessed using the System Usability Scale (SUS). We wil collect the input of breast cancer patients to the SUS questions, using in-app surveys and will calculate the SUS score. We will assess overall satisfaction with the app by asking users to provide an answer to the question "How likely are you to recommend this product to a friend" on a scale of 0-10.

Massachusetts General Hospital

Outcomes4Me

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genetic Predisposition to Disease

Disease Susceptibility

Neoplastic Syndromes, Hereditary

Hereditary Breast and Ovarian Cancer Syndrome

Genetic Diseases, Inborn

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Disease Attributes

Ovarian Cancer

Ovarian Epithelial Cancer

This sequential arm contains three types of communication to be employed following non-response to the previous type. The initial communication will be a direct message to the patient via the MyPennMedicine. The subsequent message will be sent as a text via the Way To Health app(lication). The final communication will be a nudge to the patient's physician which will send upon opening the patient's chart and will remain as a flag thereafter.

The intervention includes 3 message types: an EHR message, followed by a text message, followed by physician nudge. Each subsequent type will be activated if the previous type does not yield a response.

Sequential EHR Communications

The goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. The main question it aims to answer is: which intervention is most effective in uptake of genetic testing for the target population? Participants will receive genetic testing and counseling that may initiate life-saving screenings.

Germline genetic testing is recommended by the National Cancer Center Network (NCCN) for individuals with a personal history of ovarian cancer, young-onset (\<50 years) breast cancer, and a family history of ovarian cancer or male breast cancer, among others. Recent publications demonstrate that the uptake of genetic testing is under-utilized, overall, and rates are consistently lower in minority populations. EHR-based algorithms will be used to identify patients of two Penn Medicine Ob/Gyn practices for whom genetic testing is recommended based on NCCN guidelines and to test pragmatic methods using messages delivered to patients or clinicians to encourage testing. The ACC Electronic Phenotyping Core developed the algorithms based on cancer registry data along with family history fields and this study will develop and test messages directed at patients and clinicians to encourage testing. The aims are:

1. Identification of at-risk populations through electronic health record (EHR) searches followed by patient nudges (MPM and then Way To Health) to increase the uptake of genetic counseling referral and testing in patients at gynecology practices at Dickens Center and Penn Medicine Radnor.
2. In patients who have not responded to patient nudges (Aim 1), test a provider nudge to increase the uptake of genetic counseling referral and testing in gynecology practices at Dickens Center and Penn Medicine Radnor (Aim 2).

Eligible patients will be sent a message through the patient portal to encourage genetic counseling and testing. If the patient does not respond, they will be sent a text message. Should there be no response, the patient's clinician will receive a nudge

Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition

Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition Across Diverse Patient Populations in Gynecology Practices at Penn Medicine

The total number of referrals signed by the patient's Ob/Gyn provider for genetic counseling and testing.

Scheduling and completion of genetic counseling appointments will be monitored through EHR. MPM stands for MyPennMedicine message which will be sent directly to the patient through the medical record.

Scheduling and completion of genetic counseling appointments will be monitored through EHR. The provider nudge will be delivered as a Best Practice Alert (BPA) upon opening the patient's chart.

The proportion of eligible participants who open the invitation to receive genetic counseling and testing compared to the total amount of eligible participants sent an MPM.

The proportion of eligible participants who respond to a text message invitation to receive genetic counseling and testing compared to the total amount of eligible participants sent a Way To Health (WTH) text.

Abramson Cancer Center at Penn Medicine

Patients in the enhanced education intervention arm will be scheduled for a redesigned therapy education session with a trained oncology nurse.

Patients in this arm will receive the usual care education provided to cancer patients undergoing systemic therapy, which includes information on treatment options, side effects, and support services without targeted genetic testing education.

In addition to the education conducted as part of usual care, the nurse will: 1) provide basic education on GCT; and 2) if the patient is eligible and agreeable to GCT, place a referral to GCT (if not already ordered).

Patients will also be provided with written materials reinforcing the key messages of GCT education, designed to be understandable to individuals without a medical background. Nurses will also conduct a follow-up "nudge" by sending an in basket message via electronic medical record to ensure that the referrals are processed by the referral coordinators.

Enhanced education

A brief introduction to GCT will be provided in accordance with the information covered in the "chemo education binder," which is the current standard of care at Enloe Regional Cancer Center. As per the usual care, referrals for genetic testing will be clinician-initiated without the proactive involvement of the RN.

Usual care education

Tiffany Capuano, RN, BSN, OCN

Ranjan Pathak, MD MHS

Genetic factors are a significant determinant of the likelihood of developing various types of cancers. Identification of germline risk can have important implications for both patients and their families. Although estimates vary, pathogenic germline variants can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Unfortunately, despite progress in multigene testing and the identification of heritable conditions, genetic counseling and testing (GCT) remains underutilized among cancer patients. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier.

Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types and improve the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients.

Identification of germline risk can have important implications for both patients and their families: it can help patients develop tailored cancer surveillance, risk-reducing measures, reproductive planning, identify novel genotype-directed drug targets, and also optimally address the risk of malignancy in at-risk relatives. Although estimates vary, pathogenic germline variants (PGV) can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Although national and international guidelines such as the National Comprehensive Cancer Network (NCCN) outline the criteria for who should be offered genetic counseling and testing (GCT) based on a patient's personal and/or family history, recent studies have found that broader testing of at-risk patients might help identify PGV in patients who otherwise would not have met guidelines for genetic testing.

Unfortunately, despite progress in multigene testing and the identification of heritable conditions, GCT remains underutilized among cancer patients. A recent study revealed that the uptake of germline testing among cancer patients remains strikingly low; in California and Georgia, between 2013 and 2019, less than 7% of patients diagnosed with cancer underwent such testing. While a study indicates a promising recent increase in the use of germline testing among women diagnosed with breast and ovarian cancer from 2012 to 2019, there is still a significant gap in ensuring that all eligible patients are provided with GCT. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier.

Community cancer centers are crucial in providing accessible care to a large segment of the cancer patient population. However, community cancer centers often face various challenges with limited resources for specialized genetic services variability in community oncologists' practice patterns and perceptions in GCT, and potentially urban-rural variability in patient awareness and understanding of the potential impact of genetic testing on their care.

Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types, in addition to improving the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. This approach leverages the trust and communication between nurses and patients and the principle that informed patients are more likely to engage in their healthcare decisions to potentially overcome barriers to genetic testing uptake.

The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients. Patients in the enhanced education arm will be scheduled for an enhanced therapy education session with a trained oncology nurse for patients starting or switching their systemic therapies. In addition to the education conducted as part of the usual care, the nurse will: 1) provide detailed education on GCT; and 2) if the patient is eligible and agreeable to GCT, order a referral to GCT (if not already ordered). Nurses will provide a "nudge" to the referral coordinators within a week of the education session to ensure the referral process is completed.

This pilot study will randomize patients who are starting or switching their systemic therapies for solid cancers, eligible for GCT, and have not undergone prior genetic testing into two groups: "enhanced education intervention" and "usual care education".

A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention

Genetic Testing Uptake Through an Enhanced Oncology Nurse-Led Intervention in Patients With Solid Tumors (GENESIS): A Pilot Study

Recruitment rates (percentage of participants who agree to participate out of those approached), completion rate of follow-up assessments (percentage of patients that complete follow-up assessment), and retention rates (percentage of patients retained in the study throughout the study period).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients	NCT04262518	Breast Cancer Invasive Breast... Metastatic Brea... Breast Carcinom... Metastatic Brea...	Outcomes4Me Mob...	18 Years -	Outcomes4Me
Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients	NCT04262518	Breast Cancer Invasive Breast... Metastatic Brea... Breast Carcinom... Metastatic Brea...	Outcomes4Me Mob...	18 Years -	Outcomes4Me
Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition	NCT05721326	Genetic Predisp... Breast Cancer F... Ovarian Cancer Hereditary Brea... Hereditary Canc... Hereditary Dise... Gene Mutation-R...	Sequential EHR ...	25 Years - 100 Years	Abramson Cancer Center at Penn Medicine
A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention	NCT06436157	Solid Tumor, Ad...	Enhanced educat... Usual care educ...	18 Years -	Enloe Health

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