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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое FoRtitude 2.0
  A website and an interactive text-messaging feature
• Поведенческое Attention Control
  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.

Первичные конечные точки

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

Вторичные конечные точки (2)

• Difference in fear of recurrence based on race across all arms [Срок оценки: From enrollment to 3 months]
• Change in quality of life measures [Срок оценки: At all time points, including long term outcomes at 6, 12 and 18 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• UNC Chapel Hill School of Medicine Public Health — Chapel Hill

Идентификаторы

NCT: NCT07122492 · EAQ181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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