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

All Drugs and Chemicals

Hormones

The Oncotype DX breast cancer test measures the expression of 21 genes of an individual tumor to generate an Recurrence Score result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients.

Oncotype DX breast cancer test

Joseph GLIGOROV

Primary objective:

Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population.

The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.

Patients with HR+, N- breast cancer currently represent around 70% of newly diagnosed breast cancers. These are usually good prognosis tumors. However, on the basis of classical clinical and pathological prognostic parameters and markers, the international consensus guidelines recommend treatment with hormone- and chemotherapy in 85-95% of the cases. Considering the natural disease history, such as documented by the EBCTCG meta-analysis, more than 50% of these patients are overtreated, which leads to unnecessary side effects and costs to the health system and to the society.

Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR+, N- patients and is performed on fixed paraffin embedded tissue (FPET). It is therefore best adapted to daily clinical practice as it does not necessitate any specific surgical procedure or tissue freezing.

The prognostic and predictive value of Oncotype DX in ER+, N- patients has been validated on three large adjuvant randomized trials (NASBP B-14, NSABP B-20, and the ATAC study). The test has been commercially available in the USA since 2004, and is being used for more than 50% of the HR+ N- patients in this country.

While Oncotype DX has been validated in the USA, it needs to be independently evaluated in France, in the context of the local treatment guidelines and habits, to provide data that are meaningful to the French health system and to the French medical community.

Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients

The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.

The change in physicians' level of confidence in the treatment recommendation will be measured by the change from baseline to follow-up responses.

Registrat-Mapi

Genomic Health®, Inc.

Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video)

Watch two short videos with a 4-minute interval between the two of them, estimate 8 minutes to watch both the videos.

Video

One set of surveys before first video and one set after each video played, estimate total of 30 minutes for all surveys.

Survey

Kimberson C. Tanco, MD

The goal of this study is to learn what types of conversations patients prefer to have with their doctor about treatment options and how patients view their doctor's compassion.

If participant agree to take part in the study, basic information will be collected (such as date of birth, date of diagnosis, sex, and religion). Participant will also complete questionnaires about any symptoms they may be having, how hopeful they are, how they are accepting the disease, their trust in the medical profession, and how they like information to be delivered to them.

After completing the questionnaires, they will be randomly assigned (as the roll of dice) to one of 4 groups.

Regardless of which group they are in, they will watch 2 short videos that show actors portraying a doctor and patient having a conversation about treatment options in a clinical setting. Both videos will discuss the same material, but the order of the videos and the actors in the videos will be different for each group. Both videos are about 4 minutes long.

After watching each video, the participant will complete 3 questionnaires about the doctor in the video. It should take about 38 minutes to watch both videos and to complete all of the questionnaires.

After they have watched both videos, they will be asked to choose which doctor they preferred and to briefly explain the reasons why they chose that doctor.

Length of Study:

Participant will be off study after they have completed the last questionnaire.

Message: Study of Patients' Perception of Physician's Compassion

A Trial on Patient's Evaluation of a Physician Conveying Two Different Messages

Physician compassion tested using compassion data from the first video viewed by each patient as assessed by a Physician Compassion Assessment survey. Patient's rating of physician's compassion by using a 5-item tool consisting of five 0-10 numerical rating scales assessing five dimensions: warm-cold, pleasant-unpleasant, compassionate-distant, sensitive insensitive, caring-uncaring. The sum of the five scales will give a final score representing physician's compassion with a 0 to 50 scale.

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
Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients	NCT01446185	Breast Cancer	Oncotype DX bre...	18 Years -	Genomic Health®, Inc.
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
Message: Study of Patients' Perception of Physician's Compassion	NCT02357108	Advanced Cancer	Video Survey	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for treatment options