Clinical trial · Interventional
Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors
Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors: The FoRtitude Trial
NCT03384992CI-TRIAL-00032714FoRtitudecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 educational content and interactive tools, designed to teach coping strategies and/or inert content, depending on the study participant's randomization assignment. The FoRtitude study will examine whether three coping strategies (relaxation training, cognitive restructuring, worry practice) are more effective than general health-related content in reducing fear of cancer recurrence.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fear of Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive restructuring | Other | — | UNRESOLVED |
| Diaphragmatic breathing and relaxation | Other | — | UNRESOLVED |
| Scheduled worry practice | Other | — | UNRESOLVED |
| Telephone coaching | Other | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (16)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Participants were exposed to the following conditions: general health for week 1, diet-general information for week 2, and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.
- interventionNames
- Other: Telephone coaching
- Other: Usual care
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Participants were exposed to the one of the following usual care conditions: general health for week 1, diet-general information for week 2, and diet-BCSS information (breast cancer survivor-specific) for week 3.
- interventionNames
- Other: Usual care
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 1. Greater than 1 year post treatment (for phase I interviews and usability testing) 2. 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 Criteria: * 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.
References
Publications (2)
- DERIVEDBeeler DM, Jeter E, Leitzelar BN, Price SN, Hall DL, Raper PJ, Levine BJ, Dunsmore VJ, Tooze JA, Duffecy J, Victorson D, Gradishar W, Saphner T, Smith ML, Penedo F, Mohr DC, Cella D, Wagner LI. A qualitative examination of cognitive behavioral therapy strategies and health management content to reduce fear of cancer recurrence among breast cancer survivors: Results from the FoRtitude study. J Health Psychol. 2026 Mar;31(3):1164-1178. doi: 10.1177/13591053251354867. Epub 2025 Jul 28. PMID 40721359
- DERIVEDLucas AR, Pan JH, Ip EH, Hall DL, Tooze JA, Levine B, Mohr DC, Penedo FJ, Cella D, Wagner LI. Validation of the Lee-Jones theoretical model of fear of cancer recurrence among breast cancer survivors using a structural equation modeling approach. Psychooncology. 2023 Feb;32(2):256-265. doi: 10.1002/pon.6076. Epub 2023 Jan 9. PMID 36468339