Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors
FoRtitude
2 other identifiers
interventional
215
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2015
CompletedFirst Submitted
Initial submission to the registry
December 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedApril 30, 2018
April 1, 2018
1.8 years
December 20, 2017
April 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fear of Cancer Recurrence Inventory (FCRI) total score (minus Coping and Reassurance subscales)
Questionnaire aims to better understand the experience of worries about cancer recurrence. Scaled from 1-4 with 4 being "all the time" and 1 being "never". The FCRI is the only FoR measure validated using interview to define 'caseness' and has demonstrated reliability and validity with English speaking survivors. FCRI total score to be calculated without including the Coping and Reassurance subscales defined a priori and determined by FoR theoretical model.
Baseline to Week 8 change score
Secondary Outcomes (9)
Impact of Events Scale - Revised
Baseline to Week 8 change score
Concerns about Recurrence Scale (CARS) - 4 item severity score
Baseline to Week 8 change score
PROMIS Anxiety Computer adaptive test
Baseline to Week 8 change score
PROMIS Depression Computer adaptive test
Baseline to Week 8 change score
PROMIS Sleep Disturbance Computer adaptive test
Baseline to Week 8 change score
- +4 more secondary outcomes
Study Arms (16)
Group 1
EXPERIMENTALParticipants 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.
Group 2
EXPERIMENTALParticipants 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.
Group 3
EXPERIMENTALParticipants were exposed to the following conditions: cognitive restructuring for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.
Group 4
EXPERIMENTALParticipants were exposed to the following conditions: cognitive restructuring for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3.
Group 5
EXPERIMENTALParticipants were exposed to the following conditions: scheduled worry practice for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3. Telephone coaching was given.
Group 6
EXPERIMENTALParticipants were exposed to the following conditions: scheduled worry practice for week 1, general health for week 2, and diet-general information and diet-BCSS information (breast cancer survivor-specific) for week 3.
Group 7
EXPERIMENTALParticipants were exposed to the following conditions: cognitive restructuring for week 1, worry practice for week 2, and General Health and Diet (General and BCSS) for week 3. Telephone coaching was given.
Group 8
EXPERIMENTALParticipants were exposed to the following conditions: cognitive restructuring for week 1, scheduled worry practice for week 2, and General Health and Diet (General and BCSS) for week 3.
Group 9
EXPERIMENTALParticipants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, general health for week 2, and Diet - General and BCSS for week 3. Telephone coaching was given.
Group 10
EXPERIMENTALParticipants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, general health for week 2, and Diet - General and BCSS for week 3.
Group 11
EXPERIMENTALParticipants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, cognitive restructuring for week 2, and General health and Diet (General and BCSS) for week 3. Telephone coaching was given.
Group 12
EXPERIMENTALParticipants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, cognitive restructuring for week 2, and General health and Diet (General and BCSS) for week 3.
Group 13
EXPERIMENTALParticipants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, worry practice for week 2, and General health and Diet (General and BCSS) for week 3. Telephone coaching was given.
Group 14
EXPERIMENTALParticipants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, scheduled worry practice for week 2, and General health and Diet (General and BCSS) for week 3.
Group 15
EXPERIMENTALParticipants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, worry practice for week 2, and cognitive restructuring for week 3. Telephone coaching was given.
Group 16
EXPERIMENTALParticipants were exposed to the following conditions: Diaphragmatic breathing and relaxation for week 1, scheduled worry practice for week 2, and cognitive restructuring for week 3.
Interventions
Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions. Includes an interactive tool (thought record) participants complete to facilitate this process.
Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies. Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Beeler 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. 2025 Jul 28:13591053251354867. doi: 10.1177/13591053251354867. Online ahead of print.
PMID: 40721359DERIVEDLucas 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: 36468339DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynne Wagner, Ph.D.
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2017
First Posted
December 28, 2017
Study Start
March 1, 2014
Primary Completion
December 5, 2015
Study Completion
December 5, 2015
Last Updated
April 30, 2018
Record last verified: 2018-04