A Targeted Electronic Health Approach to Reduce Fear of Recurrence in Breast Cancer Survivors (Fo… (NCT07122492) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Targeted Electronic Health Approach to Reduce Fear of Recurrence in Breast Cancer Survivors (FoRtitude)
United States800 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
NOTE: Current hormonal therapy is allowed. NOTE: Primary treatment can include chemotherapy and/or surgery and/or radiation therapy.
\- Participant must be receiving their care (cancer treatment or survivorship care) from an oncology provider affiliated with the NCORP site and are expected to continue care at the site for the next 18 months.
NOTE: This eligibility criteria is intended to ensure access to healthcare utilization data. Oncology provider can include an Advance Practice Provider, Advance Nurse Practitioner, oncologist, primary care provider, or nurse or physician responsible for survivorship care.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fear of Cancer Recurrence Inventory (FCRI)
Timeframe: From 1 month post-intervention to 3 months post-intervention