Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors
NCT ID: NCT03384992
Last Updated: 2018-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
215 participants
INTERVENTIONAL
2014-03-31
2015-12-05
Brief Summary
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Detailed Description
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After refining the FoRtitude site, the investigators will conduct a randomized controlled trial using the Multiphase Optimization Strategy (MOST) to individually evaluate three coping strategies; each coping strategy will be compared to health management content. Inert content includes general health information and managing comorbid illnesses, information on general nutrition, and information on nutritional topics of interest to BCS. Half of the participants will be randomized to receive telecoaching, which included 3-4 telephone-based brief sessions with a motivational interviewer, aimed at improving adherence to use of the FoRtitude site. Participants will complete questionnaires at baseline, 4 weeks (immediately after completing the FoRtitude site) and at 8 weeks.
Study hypotheses:
1. BCS randomized to Relaxation training will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
2. BCS randomized to Cognitive restructuring will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
3. BCS randomized to Scheduled Worry practice will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to inert (health management) content
4. BCS randomized to receive Telecoaching will demonstrate higher adherence to using the FoRtitude site and will report a greater reduction in fear of cancer recurrence from pre-post intervention compared to BCS randomized to no Telecoaching
5. BCS randomized to a higher number of coping strategies will report a greater reduction in fear of cancer recurrence from pre-post intervention than BCS randomized to receive all inert content or fewer coping strategies (dose-response effect)
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group 1
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.
Telephone coaching
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 2
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 3
Participants 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.
Cognitive restructuring
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.
Telephone coaching
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 4
Participants 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.
Cognitive restructuring
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 5
Participants 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.
Scheduled worry practice
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.
Telephone coaching
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 6
Participants 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.
Scheduled worry practice
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 7
Participants 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.
Cognitive restructuring
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.
Scheduled worry practice
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.
Telephone coaching
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 8
Participants 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.
Cognitive restructuring
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.
Scheduled worry practice
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 9
Participants 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.
Diaphragmatic breathing and relaxation
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).
Telephone coaching
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 10
Participants 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.
Diaphragmatic breathing and relaxation
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).
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 11
Participants 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.
Diaphragmatic breathing and relaxation
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).
Cognitive restructuring
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.
Telephone coaching
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 12
Participants 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.
Diaphragmatic breathing and relaxation
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).
Cognitive restructuring
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 13
Participants 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.
Diaphragmatic breathing and relaxation
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).
Scheduled worry practice
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.
Telephone coaching
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 14
Participants 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.
Diaphragmatic breathing and relaxation
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).
Scheduled worry practice
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Group 15
Participants 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.
Diaphragmatic breathing and relaxation
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).
Cognitive restructuring
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.
Scheduled worry practice
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.
Telephone coaching
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.
Group 16
Participants 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.
Diaphragmatic breathing and relaxation
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).
Cognitive restructuring
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.
Scheduled worry practice
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.
Interventions
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Diaphragmatic breathing and relaxation
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).
Cognitive restructuring
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.
Scheduled worry practice
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.
Telephone coaching
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.
Usual care
Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Lynne Wagner, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
References
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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.
Lucas 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.
Other Identifiers
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IRB00036679
Identifier Type: -
Identifier Source: org_study_id