YES Study - Newly Diagnosed/Metastatic Intervention

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Breast Cancer; Symptom, Behavioral

Treatments: Behavioral: YES portal

Study type: Interventional

Funder types: Other

Identifiers

NCT04379414

20-124

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

-

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 4 patient groups

Newly Diagnosed Automatic Symptom Information

Experimental group

Description:

Eligible participants are consented and enrolled and randomized into 1 or 4 groups in the study. Randomization allocation not shared directly with participant. * Participants with early stage breast cancer will respond to baseline (at enrollment) and follow-up outcome surveys via. Participants will then create a personal YES portal account and automatically receive information on sexual health and vaginal dryness. Participants will also complete serial monitoring assessments in the portal. * YES portal assessments will be sent once a week for the first 12 weeks (each assessment will take approximately 10-15 minutes). After 12 weeks of weekly assessments in YES portal, the frequency of assessments will be changed to once every month. * Surveys will be sent once every 6 months for the first 3 years, then annually. * Participants will be asked to allow for medical record review, two blood samples (baseline and 3-6 months), and a sample of any tissue available to bank.

Treatment:

Behavioral: YES portal

Newly Diagnosed Trigger Symptom Information

Experimental group

Description:

Eligible participants are consented and enrolled and randomized into 1 or 4 groups in the study. Randomization allocation not shared directly with participant. * Participants with early stage breast cancer will respond to baseline (at enrollment) and follow-up outcome surveys via. Participants will then create a personal YES portal account and automatically receive information on sexual health and vaginal dryness. Participants will also complete serial monitoring assessments in the portal. * YES portal assessments will be sent once a week for the first 12 weeks (each assessment will take approximately 10-15 minutes). After 12 weeks of weekly assessments in YES portal, the frequency of assessments will be changed to once every month. * Surveys will be sent once every 6 months for the first 3 years, then annually. * Participants will be asked to allow for medical record review, two blood samples (baseline and 3-6 months), and a sample of any tissue available to bank.

Treatment:

Behavioral: YES portal

Metastatic Automatic Symptom Information

Experimental group

Description:

Eligible participants are consented and enrolled and randomized into 1 or 4 groups in the study. Randomization allocation not shared directly with participant. * Participants with early stage breast cancer will respond to baseline (at enrollment) and follow-up outcome surveys via. Participants will then create a personal YES portal account and automatically receive information on sexual health and vaginal dryness. Participants will also complete serial monitoring assessments in the portal. * YES portal assessments will be sent once a week for the first 12 weeks (each assessment will take approximately 10-15 minutes). After 12 weeks of weekly assessments in YES portal, the frequency of assessments will be changed to once every month. * Surveys will be sent once every 6 months for the first 3 years, then annually. * Participants will be asked to allow for medical record review, two blood samples (baseline and 3-6 months), and a sample of any tissue available to bank.

Treatment:

Behavioral: YES portal

Metastatic Trigger Symptom Information

Experimental group

Description:

Eligible participants are consented and enrolled and randomized into 1 or 4 groups in the study. Randomization allocation not shared directly with participant. * Participants with early stage breast cancer will respond to baseline (at enrollment) and follow-up outcome surveys via. Participants will then create a personal YES portal account and automatically receive information on sexual health and vaginal dryness. Participants will also complete serial monitoring assessments in the portal. * YES portal assessments will be sent once a week for the first 12 weeks (each assessment will take approximately 10-15 minutes). After 12 weeks of weekly assessments in YES portal, the frequency of assessments will be changed to once every month. * Surveys will be sent once every 6 months for the first 3 years, then annually. * Participants will be asked to allow for medical record review, two blood samples (baseline and 3-6 months), and a sample of any tissue available to bank.

Treatment:

Behavioral: YES portal