A Targeted Electronic Health Approach to Reduce Fear of Recurrence in Breast Cancer Survivors (FoRtitude)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Eastern Cooperative Oncology Group
Study ID
NCT07122492
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Survivor
  • Fear of Cancer Recurrence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • FoRtitude 2.0 — BEHAVIORAL
    A website and an interactive text-messaging feature
  • Attention Control — BEHAVIORAL
    Access to the non-interactive study intervention website that lists links to help you access websites that provide information to read and resources for breast cancer survivors.

Study Details

The goal of this study is to determine if the intervention or if general information about being a breast cancer survivor can help Breast Cancer Survivors reduce their fear of recurrence. The main question it aims to answer are: Can the FoRtitude intervention lower the fear of recurrence for Breast Cancer Survivors? Participants will: Answer questions about their fear of recurrence. Be randomized to 1 of the 3 following options: (1) a weblink to access an eHealth intervention which includes a website and an optional interactive text-messaging feature, (2) a weblink to a non-interactive website that will include links to external websites with general information that may be helpful for Breast Cancer Survivors, or (3) you will need to talk with your oncology team about your concerns about recurrence or seek psychosocial care in the community. Be asked to fill out questionnaires 5 times for up to 18 months.

Key Dates

Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intervention
    Access to the study intervention website with interactive content, including information to read and videos to watch, and an optional text-messaging feature
  • Other: Attentive Care
    Access to the non-interactive study intervention website that lists links to help you access websites that provide information to read and resources for breast cancer survivors.
  • No Intervention: Usual Care
    Usual care for fear of recurrence.

Primary Outcome Measure

Fear of Cancer Recurrence Inventory (FCRI) [ Time Frame: From 1 month post-intervention to 3 months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Chapel Hill School of Medicine Public HealthChapel HillNorth Carolina27599
Lynne I Wagner, Ph.D.
[email protected]
(919) 966-7392

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By research site
UNC Chapel Hill School of Medicine Public Health· Chapel Hill, NC

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