NCT02340494

Brief Summary

This project proposes to develop and test an internet resource - a supported self-management website - that will guide younger women to relevant knowledge and resources, and provide tools that will help YWBC become more skilled and confident in coping with the many challenges of breast cancer. The study will be conducted in collaboration with the newly funded, pan-Canadian Young Breast Cancer Cohort (CYBCC) program being led from Women's College Hospital. The resource is expected to reduce knowledge gaps experienced by YWBC, and help them be partners in decision-making about their care, which has been shown to reduce anxiety and depression years later.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

January 13, 2015

Last Update Submit

January 13, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Traumatic stress

    Tramatic stress will be assessed with the Impact of Event Scale (IES), measuring intrusion and avoidance symptoms related to the diagnosis of breast cancer.

    4 months

Secondary Outcomes (1)

  • Cancer Behavior Inventory

    4 months

Study Arms (2)

Control group

NO INTERVENTION

Women without access to the website.

Intervention group

EXPERIMENTAL

Women with access to the website.

Behavioral: Online Enhanced Education Tool

Interventions

The website resource will be credible, comprehensive, relevant and engaging information that young women with breast cancer will use intensively for self-management and education.

Intervention group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • are diagnosed with invasive or ductal carcinoma in-situ disease
  • are able to read and understand English

You may not qualify if:

  • under 18 or over 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Dina Nikitina, MPH

CONTACT

Cil Tulin, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Last Updated

January 16, 2015

Record last verified: 2015-01