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Study to Reduce Fear of Recurrence in Breast Cancer Survivors

This study, called FoRtitude, is looking at ways to help breast cancer survivors reduce their fear of cancer coming back. It's testing if a website and optional text messages (FoRtitude 2.0) can be more helpful than a website with general information or talking to your oncology team. To join, you must be a woman at least 18 years old who had Stage 0-III breast cancer and finished your main treatment (like chemotherapy, surgery, or radiation) 1 to 10 years ago. The study will measure your fear of recurrence using a questionnaire between 1 and 3 months after you start. The study aims to enroll 800 participants, but its current recruitment status is unclear.

Study design
This is an interventional study that plans to enroll 800 participants. You will be randomly assigned to one of three groups: the FoRtitude 2.0 intervention, a website with general information, or a group where you talk with your oncology team.
What's involved
You will answer questions about your fear of recurrence and access one of the study options. The study measures fear of recurrence between 1 and 3 months after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Your fear of recurrence will be measured between 1 and 3 months after you start the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07122492

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

Not Yet Recruiting
NAAges 18+Interventional
Eastern Cooperative Oncology Group
~800 participants
Updated 2025-08-14 on ClinicalTrials.gov
What's tested:FoRtitude 2.0Attention Control

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fear of Cancer Recurrence Inventory (FCRI)
Measured over From 1 month post-intervention to 3 months post-intervention

Conditions

Breast Cancer Survivor
Fear of Cancer Recurrence

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Lynne I Wagner, Ph.D. · STUDY_CHAIR · UNC Chapel Hill Gillings School of Global Public Health

Who to contact

Lynne I Wagner, Ph.D.
[email protected]
(919) 966-7392
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must be ≥ 18 years of age.
Participant must have had histologically confirmed Stage 0-III breast cancer at time of diagnosis.
Participant must have completed primary treatment 1-10 years prior to Step 0 registration.
Participant must have no evidence of active cancer of any type at the time of Step 0 registration (per the assessment of the physician), excluding local basal cell or squamous cell carcinoma.
Participant must be fluent in written and spoken English.
Participant must have an ECOG Performance Status of 0-2.
Participant must have the ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) are not eligible.
Participant must complete the FCRI 9-item severity scale and report a score of 13 or higher.
Participant must have access to the internet (via smartphone, tablet, or computer).
Participant must have completed the Baseline Assessment within 60 days of Step 0 registration.
Randomization to Step 1 must occur within 60 days of Step 0 registration.

Exclusion

Participant must not have any psychiatric or cognitive conditions that may affect the participant's ability to accurately provide self-report data, per clinical discretion.

What this trial measures

  • Fear of Cancer Recurrence Inventory (FCRI)From 1 month post-intervention to 3 months post-intervention

    Fear of Cancer Recurrence Inventory (FCRI) modified total score 143 (without coping or reassurance subscale items) measured during the study period. A graphical exploration of the data will be performed by examining the distribution of FCRI score at each follow up timepoint, as well as the changes in FCRI between the baseline and follow up visits. 1-month post-intervention completion (3 months post-randomization) will be defined as the primary comparison. For the primary analysis we will compare the FCRI score of the FoRtitude arm to each of two control arms at 3 months using Welch's t-test. Two two-group Welch's t-tests will be used to compare the FCRI score of the FoRtitude arm to each of the two control arms at 12 weeks.