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Breast CancerFoRtitudeNCT03384992

Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors

A study testing Diaphragmatic breathing and relaxation, Cognitive restructuring and Scheduled worry practice in people with Breast Cancer and Fear of Cancer, run by Wake Forest University Health Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Fear of Cancer
What is being tested?
Diaphragmatic breathing and relaxation, Cognitive restructuring and Scheduled worry practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
No sites listed yet
Study dates
Mar 2014to 5 Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 17Show fewer
  • 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
  • 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)

Who cannot join

  • 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.

About this study

Official title: Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors: The FoRtitude Trial

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.

Read the 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 (FoR). FoRtitude, a web-based program with interactive text messaging capabilities, was created to deliver a targeted intervention for BCS with moderate to severe FoR. FoRtitude consists of didactic content presented in written and video-based formats and interactive tools, designed to teach coping strategies. Commonly used cognitive behavior therapy (CBT) techniques were tailored to the management of FoR and included diaphragmatic breathing and relaxation, cognitive restructuring, and scheduled worry practice. Participants are encouraged to use the FoRtitude site several times per week over a period of 4 weeks. The investigators employed principles of user-centered design to create the FoRtitude website and incorporated feedback from 17 BCS to refine site content and improve FoRtitude usability.

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)
Being tested
Diaphragmatic breathing and relaxation, Cognitive restructuring, Scheduled worry practice, Telephone coaching, Usual care
Keywords
Fear of Cancer Recurrence, ehealth interventions, PROMIS, FoR
Medical subject headings
Breast Neoplasms, Pathophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diaphragmatic breathing and relaxationOther

    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 restructuringOther

    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 practiceOther

    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 coachingOther

    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 careOther

    Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.

Study groups in NCT03384992
Study groupRoleWhat they receive
Group 1ExperimentalParticipants 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.
Receives: Other: Telephone coaching; Other: Usual care
Group 2ExperimentalParticipants 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.
Receives: Other: Usual care
Group 3ExperimentalParticipants 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.
Receives: Other: Cognitive restructuring; Other: Telephone coaching; Other: Usual care
Group 4ExperimentalParticipants 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.
Receives: Other: Cognitive restructuring; Other: Usual care
Group 5ExperimentalParticipants 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.
Receives: Other: Scheduled worry practice; Other: Telephone coaching; Other: Usual care
Group 6ExperimentalParticipants 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.
Receives: Other: Scheduled worry practice; Other: Usual care
Group 7ExperimentalParticipants 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.
Receives: Other: Cognitive restructuring; Other: Scheduled worry practice; Other: Telephone coaching; Other: Usual care
Group 8ExperimentalParticipants 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.
Receives: Other: Cognitive restructuring; Other: Scheduled worry practice; Other: Usual care
Group 9ExperimentalParticipants 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.
Receives: Other: Diaphragmatic breathing and relaxation; Other: Telephone coaching; Other: Usual care
Group 10ExperimentalParticipants 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.
Receives: Other: Diaphragmatic breathing and relaxation; Other: Usual care
Group 11ExperimentalParticipants 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.
Receives: Other: Diaphragmatic breathing and relaxation; Other: Cognitive restructuring; Other: Telephone coaching; Other: Usual care
Group 12ExperimentalParticipants 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.
Receives: Other: Diaphragmatic breathing and relaxation; Other: Cognitive restructuring; Other: Usual care
Group 13ExperimentalParticipants 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.
Receives: Other: Diaphragmatic breathing and relaxation; Other: Scheduled worry practice; Other: Telephone coaching; Other: Usual care
Group 14ExperimentalParticipants 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.
Receives: Other: Diaphragmatic breathing and relaxation; Other: Scheduled worry practice; Other: Usual care
Group 15ExperimentalParticipants 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.
Receives: Other: Diaphragmatic breathing and relaxation; Other: Cognitive restructuring; Other: Scheduled worry practice; Other: Telephone coaching
Group 16ExperimentalParticipants 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.
Receives: Other: Diaphragmatic breathing and relaxation; Other: Cognitive restructuring; Other: Scheduled worry practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 8 change score

Secondary outcomes (9)

  1. Impact of Events Scale - Revised

    Questionnaire to assess illness-related distress and post-truamatic type anxiety

    Measured: Baseline to Week 8 change score

  2. Concerns about Recurrence Scale (CARS) - 4 item severity score

    Questionnaire to assess concerns about recurrence among BCS

    Measured: Baseline to Week 8 change score

  3. PROMIS Anxiety Computer adaptive test

    Questions administered using a computer adaptive test-based algorithm to assess overall anxiety

    Measured: Baseline to Week 8 change score

  4. PROMIS Depression Computer adaptive test

    Questions administered using a computer adaptive test-based algorithm to assess depression

    Measured: Baseline to Week 8 change score

  5. PROMIS Sleep Disturbance Computer adaptive test

    Questions administered using a computer adaptive test-based algorithm to assess sleep disturbances

    Measured: Baseline to Week 8 change score

  6. PROMIS Fatigue Computer adaptive test

    Questions administered using a computer adaptive test-based algorithm to assess fatigue

    Measured: Baseline to Week 8 change score

  7. PROMIS Global Health

    Questionnaire to assess overall health and health-related quality of life

    Measured: Baseline to Week 8 change score

  8. PROMIS Applied Cognition Computer adaptive test

    Questions administered using a computer adaptive test-based algorithm to assess patient-reported cognitive impairments

    Measured: Baseline to Week 8 change score

  9. Breast Cancer Self-Efficacy scale (BCSE)

    Questionnaire to assess confidence in one's ability to manage breast cancer

    Measured: Baseline to Week 8 change score

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2017
  2. Study startMar 2014
  3. Primary completion5 Dec 2015
  4. Study completion5 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Model description
FoRtitude includes three CSMs: (1) diaphragmatic breathing and relaxation, (2) cognitive restructuring, and (3) scheduled worry practice. The fourth intervention component is (4) telephone coaching. We assigned two levels (yes, no) to each component. Evaluating individual and combined intervention components, each with two levels, results in a classic full factorial design with 16 (2 x 2 x 2 x 2) experimental conditions
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03384992
Sponsor's protocol ID
IRB00036679
Other IDs
1R21CA173193-01A1
Acronym
FoRtitude
Status last verified
Apr 2018
First submitted
20 Dec 2017
Last updated
30 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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. 2026 Mar;31(3):1164-1178. doi: 10.1177/13591053251354867. Epub 2025 Jul 28.

    PubMed 40721359

  • 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.

    PubMed 36468339

Questions about this trial

What is this clinical trial studying?

A study testing Diaphragmatic breathing and relaxation, Cognitive restructuring and Scheduled worry practice in people with Breast Cancer and Fear of Cancer, run by Wake Forest University Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of Cancer Recurrence Inventory (FCRI) total score (minus Coping and Reassurance subscales) (time frame: Baseline to Week 8 change score). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03384992, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.

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