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

Randomized Controlled Trial of FoRtitude: Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors in Community Oncology Settings

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 18 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Be asked to fill out questionnaires 5 times for up to 18 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether FoRtitude, a website with optional text messages, can help breast cancer survivors feel less afraid that cancer will return. It is for adults who finished their main breast cancer treatment 1–10 years ago. Participants are assigned by chance to FoRtitude, a general information website, or advice to talk with their cancer care team or seek support in their community.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have had stage 0–III breast cancer confirmed by a tissue test.
  • Have finished main treatment, such as surgery, chemotherapy, or radiation, 1–10 years before signing up. Hormone therapy is allowed.
  • Get cancer or follow-up care from a provider linked to the study's NCORP site, and expect to continue there for 18 months.
  • Have no active cancer, as judged by a doctor, except local basal cell or squamous cell skin cancer.
  • Speak and read English fluently, and have internet access through a phone, tablet, or computer.
  • Have an ECOG activity score of 0–2: be able to care for yourself and be out of bed or a chair for more than half the day. Be able to understand and willing to sign the consent form.
  • Score at least 13 on a 9-question survey about fear of cancer returning.
  • Complete the starting survey and be assigned to a study group within 60 days of signing up.

Who can't join

  • Have a mental health or thinking condition that, in the care team's judgment, could make your survey answers less accurate.
  • Have trouble making informed decisions about taking part in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 access to the internet (via smartphone, tablet, or computer). NOTE: The restriction to those with internet access is based on the primary intention of the study which involves internet-based delivery intervention content delivered via the internet. * 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 Criteria: * 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.

Study sites (1)

NC