Status:
COMPLETED
Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Fear of Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The FoRtitude trial aims to evaluate an eHealth intervention designed to teach breast cancer survivors strategies to manage anxiety about cancer recurrence. The eHealth intervention includes education...
Detailed Description
The purpose of the FoRtitude trial is to develop and evaluate a targeted eHealth intervention designed to teach breast cancer survivors (BCS) coping strategies to manage fear about cancer recurrence (...
Eligibility Criteria
Inclusion
- Female
- Diagnosis of breast cancer, non-metastatic, stage I-III
- Completed primary treatment for breast cancer (surgery, chemotherapy and/or radiation therapy, current hormonal treatment allowable)
- No current evidence of disease
- Greater than 1 year post treatment (for phase I interviews and usability testing)
- Between 1 and 10 years post-treatment (for Phase I field testing and Phase II)
- Good overall functional status as evidenced by ECOG Performance Status \< 3
- At least 18 years of age (for Phase I only)
- At least 19 years of age (for Phase 2 only)
- Able to speak and read English
- Able to provide informed consent
- Clinically significant FoR, measured by the 9-item FCRI severity scale using established cut-off
- a. Patients may be eligible for Phase I and Phase IV of the study regardless of their FCRI score
- Cellular telephone with SMS messaging capability and access to a computer with broadband Internet access
- Self-reported familiarity with the Internet per Internet Usage Patterns Measure
- For Phase III, participants must have participated in Phase II
- For Phase IV, participants must be a self-identified African American breast cancer survivor that is willing to review site content and provide feedback in addition to meeting inclusion criteria above (with exception of FCRI severity scale score)
Exclusion
- Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
- Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous
- Hazardous substance or alcohol use
- Suicidal ideation, plan, intent
- Dementia
- Or if the participant is deemed ineligible by the investigators for reasons not otherwise specified.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2015
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT03384992
Start Date
March 1 2014
End Date
December 5 2015
Last Update
April 30 2018
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