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.
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 not have any psychiatric or cognitive conditions that may affect the participant's ability to accurately provide self-report data, per clinical discretion.
Parallel
FoRtitude 2.0
BehavioralA website and an interactive text-messaging feature
Attention Control
BehavioralAccess 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.
Fear of Cancer Recurrence Inventory (FCRI)
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.
Difference in fear of recurrence based on race across all arms
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.
Change in quality of life measures
A per-comparison-wise error rate approach (PCWER) will be used.
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This trial is not recruiting at the moment. You can still explore other options:
