Clinical trial NCT04379414: YES Study - Newly Diagnosed/Metastatic Intervention
Official title: Young, Empowered &Amp; Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Newly Diagnosed/Metastatic Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Symptom, Behavioral
Keywords: Breast Cancer
Symptom, Behavioral
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2020-05-07
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer using a web-based portal (YES), built for smartphones, tablets, and computers.

Detailed description: This is a prospective, interventional cohort study with an embedded Phase II randomized controlled clinical trial with a parallel design.

* The research study procedures include screening for eligibility, consent, enrolled, randomization into 1 of 4 groups.
* The study interventions including the (web-based portal ) YES portal use including regular assessments, serial outcome surveys, medical record review, and tumor/blood collection.
* The YES portal is a web-based portal designed for access by smartphone, tablet, or laptop/desktop. The portal is designed to help monitor cancer related issues and to share self-management information and resources to those interested in particular issues or who score high enough on the symptom measures designed to assess and track noticeable symptoms (and thus might benefit from such), as well as to share potential research opportunities when available. The portal is also designed to create a community among participants through the yeschat.org discussion board
* Participants will be in this research study for up to 5 years with the option to opt out of portal assessment component follow-up after only 1 year.
* It is expected that about 400 people will take part in this research study

Eligibility criteria: Inclusion Criteria:

* Stage 0-3

  * Female
  * diagnosed with breast cancer between the ages of 18-39 years
  * less than 3 months post diagnosis date of new primary or local recurrence (prior history of other cancer is allowed as long as treated with curative intent and no evidence of disease from that cancer)
  * has not started treatment for breast cancer diagnosis yet
  * is planning to get care at DFCI
  * be fluent in and able to read English
  * have internet access on a regular basis at the time of consent that can support the web-based platform
* Stage IV

  * Female
  * initial diagnosis of breast cancer between the ages of 18-39 years
  * be fluent in and able to read English
  * have internet access on a regular basis at the time of consent that can support the web-based platform

Exclusion Criteria:

-

Primary outcomes:
measure: Vaginal dryness
timeFrame: 1 year
Secondary outcomes:
measure: Socio-demographics
timeFrame: Up to 5 years
measure: Financial burden
timeFrame: Up to 5 years
measure: Smoking and alcohol use
timeFrame: Up to 5 years
measure: Physical Activity
timeFrame: Up to 5 years
measure: Mobility
timeFrame: Up to 5 years
measure: Self-Care
timeFrame: Up to 5 years
measure: Usual Activities
timeFrame: Up to 5 years
measure: Pain and Discomfort
timeFrame: Up to 5 years
measure: Anxiety and Depression
timeFrame: Up to 5 years
measure: Overall Symptoms
timeFrame: Up to 5 years
measure: Adherence to Hormonal or other Oral Therapy
timeFrame: Up to 5 years
measure: Adolescent and Young Adult (AYA) Concerns
timeFrame: Up to 5 years
measure: Emotional Symptoms
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ann H Partridge, MD
role: PRINCIPAL_INVESTIGATOR
References: