UNC Chapel Hill School of Medicine Public Health
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT07122492
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
NOTE: Current hormonal therapy is allowed. NOTE: Primary treatment can include chemotherapy and/or surgery and/or radiation therapy.
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.
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.
Exclusion criteria
A website and an interactive text-messaging feature
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.
Time frame: 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.
Time frame: From enrollment to 3 months
A mixed model, including indicator variables for arm, race, and time, will be used and will include the interactions of race by arm and race by time. The FCRI modified total score of the FoRtitude arm to each of two control arms will be compared at 3 months using a two-group t-test with linear contrasts.
Time frame: At all time points, including long term outcomes at 6, 12 and 18 months.
A per-comparison-wise error rate approach (PCWER) will be used.
Contact information is provided by the study sponsor or research team.
Eastern Cooperative Oncology Group
Network
Randomized Controlled Trial of FoRtitude: Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors in Community Oncology Settings
Acronym: FoRtitude
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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