YES Study - Newly Diagnosed/Metastatic Intervention

NCT04379414 | Active Not Recruiting

• 1 other identifier: 20-124
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Symptom, Behavioral

Keywords

Breast Cancer; Symptom, Behavioral

Outcome Measures

Primary Outcomes (1)

• Vaginal dryness

  One item regarding vaginal dryness on the BCPT will be used and grouped by moderate, quite a bit, extreme responses to define the vaginal dryness rate at 1 year. Based on historical data (from our ongoing Young Women's Breast Cancer Study), the 1-year vaginal dryness rate for the control group is assumed to be 27%. For the Phase II randomized controlled trial component of the study,it will have 85% power to detect a 10% difference in the primary endpoint with 367 patients, and would plan to recruit 408 to account for dropout (last row of the table).

  1 year

Secondary Outcomes (13)

• Socio-demographics

  Up to 5 years

• Financial burden

  Up to 5 years

• Smoking and alcohol use

  Up to 5 years

• Physical Activity

  Up to 5 years

• Mobility

  Up to 5 years

Study Arms (4)

Newly Diagnosed Automatic Symptom Information

EXPERIMENTAL

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.

Behavioral: YES portal

Newly Diagnosed Trigger Symptom Information

EXPERIMENTAL

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.

Behavioral: YES portal

Metastatic Automatic Symptom Information

EXPERIMENTAL

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.

Behavioral: YES portal

Metastatic Trigger Symptom Information

EXPERIMENTAL

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.

Behavioral: YES portal

Interventions

YES portal BEHAVIORAL

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, resources and potential research opportunities. The portal is also designed to create a community among participants through the yeschat.org discussion board.

Metastatic Automatic Symptom Information; Metastatic Trigger Symptom Information; Newly Diagnosed Automatic Symptom Information; Newly Diagnosed Trigger Symptom Information

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Ann H Partridge, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: September 16, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH

Locations

US (1)