Breast Cancer SurvivorFoRtitudeNCT07122492
A Targeted Electronic Health Approach to Reduce Fear of Recurrence in Breast Cancer Survivors (FoRtitude)
A study testing FoRtitude 2.0 in people with Breast Cancer Survivor and Fear of Cancer Recurrence, run by Eastern Cooperative Oncology Group at 1 site in United States.
Trial summary
The goal of this study is to determine if the intervention or if general information about being a breast cancer survivor can help Breast Cancer Survivors reduce their fear of recurrence. 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 Survivor, Fear of Cancer Recurrence
- What is being tested?
- FoRtitude 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participant must be ≥ 18 years of age.
- Participant must have had histologically confirmed Stage 0-III breast cancer at time of diagnosis.
- Participant must have completed primary treatment 1-10 years prior to Step 0 registration.
- NOTE: Current hormonal therapy is allowed. NOTE: Primary treatment can include chemotherapy and/or surgery and/or radiation therapy.
- Participant must be receiving their care (cancer treatment or survivorship care) from an oncology provider affiliated with the NCORP site and are expected to continue care at the site for the next 18 months.
- NOTE: This eligibility criteria is intended to ensure access to healthcare utilization data. Oncology provider can include an Advance Practice Provider, Advance Nurse Practitioner, oncologist, primary care provider, or nurse or physician responsible for survivorship care.
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- Participant must have no evidence of active cancer of any type at the time of Step 0 registration (per the assessment of the physician), excluding local basal cell or squamous cell carcinoma.
- Participant must be fluent in written and spoken English.
- Participant must have an ECOG Performance Status of 0-2.
- Participant must have the ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) are not eligible.
- Participant must complete the FCRI 9-item severity scale and report a score of 13 or higher.
- Participant must have access to the internet (via smartphone, tablet, or computer).
- NOTE: The restriction to those with internet access is based on the primary intention of the study which involves internet-based delivery intervention content delivered via the internet.
- Participant must have completed the Baseline Assessment within 60 days of Step 0 registration.
- Randomization to Step 1 must occur within 60 days of Step 0 registration.
Who cannot join
- Participant must not have any psychiatric or cognitive conditions that may affect the participant's ability to accurately provide self-report data, per clinical discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UNC Chapel Hill School of Medicine Public Health
Chapel Hill, North Carolina, 27599
Lynne I Wagner, Ph.D., (919) 966-7392, lynne.wagner@unc.edu
About this study
Official title: Randomized Controlled Trial of FoRtitude: Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors in Community Oncology Settings
The goal of this study is to determine if the intervention or if general information about being a breast cancer survivor can help Breast Cancer Survivors reduce their fear of recurrence. The main question it aims to answer are:
Can the FoRtitude intervention lower the fear of recurrence for Breast Cancer Survivors?
Read more
Participants will:
Answer questions about their fear of recurrence. Be randomized to 1 of the 3 following options: (1) a weblink to access an eHealth intervention which includes a website and an optional interactive text-messaging feature, (2) a weblink to a non-interactive website that will include links to external websites with general information that may be helpful for Breast Cancer Survivors, or (3) you will need to talk with your oncology team about your concerns about recurrence or seek psychosocial care in the community.
Be asked to fill out questionnaires 5 times for up to 18 months.
- Conditions
- Breast Cancer Survivor, Fear of Cancer Recurrence
- Being tested
- FoRtitude 2.0, Attention Control
- Keywords
- Breast cancer survivor, Fear of recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoRtitude 2.0Behavioural
A website and an interactive text-messaging feature
Attention ControlBehavioural
Access to the non-interactive study intervention website that lists links to help you access websites that provide information to read and resources for breast cancer survivors.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to the study intervention website with interactive content, including information to read and videos to watch, and an optional text-messaging feature Receives: Behavioral: FoRtitude 2.0 |
| Attentive Care | Other | Access to the non-interactive study intervention website that lists links to help you access websites that provide information to read and resources for breast cancer survivors. Receives: Behavioral: Attention Control |
| Usual Care | No intervention | Usual care for fear of recurrence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Cancer Recurrence Inventory (FCRI)
Fear of Cancer Recurrence Inventory (FCRI) modified total score 143 (without coping or reassurance subscale items) measured during the study period. A graphical exploration of the data will be performed by examining the distribution of FCRI score at each follow up timepoint, as well as the changes in FCRI between the baseline and follow up visits. 1-month post-intervention completion (3 months post-randomization) will be defined as the primary comparison. For the primary analysis we will compare the FCRI score of the FoRtitude arm to each of two control arms at 3 months using Welch's t-test. Two two-group Welch's t-tests will be used to compare the FCRI score of the FoRtitude arm to each of the two control arms at 12 weeks.
Measured: From 1 month post-intervention to 3 months post-intervention
Secondary outcomes (2)
Difference in fear of recurrence based on race across all arms
A mixed model, including indicator variables for arm, race, and time, will be used and will include the interactions of race by arm and race by time. The FCRI modified total score of the FoRtitude arm to each of two control arms will be compared at 3 months using a two-group t-test with linear contrasts.
Measured: From enrollment to 3 months
Change in quality of life measures
A per-comparison-wise error rate approach (PCWER) will be used.
Measured: At all time points, including long term outcomes at 6, 12 and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Lynne I Wagner, Ph.D., Study chair, UNC Chapel Hill Gillings School of Global Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122492
- Sponsor's protocol ID
- EAQ181
- Acronym
- FoRtitude
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of FoRtitude: Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors in Community Oncology Settings
- ClinicalTrials.gov ID
- NCT07122492
- Acronym / sponsor ID
- FoRtitude / EAQ181
- Conditions
- Breast Cancer Survivor, Fear of Cancer Recurrence
- Keywords
- Breast cancer survivor, Fear of recurrence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if the intervention or if general information about being a breast cancer survivor can help Breast Cancer Survivors reduce their fear of recurrence. The main question it aims to answer are:
Can the FoRtitude intervention lower the fear of recurrence for Breast Cancer Survivors?
Participants will:
Answer questions about their fear of recurrence. Be randomized to 1 of the 3 following options: (1) a weblink to access an eHealth intervention which includes a website and an optional interactive text-messaging feature, (2) a weblink to a non-interactive website that will include links to external websites with general information that may be helpful for Breast Cancer Survivors, or (3) you will need to talk with your oncology team about your concerns about recurrence or seek psychosocial care in the community.
Be asked to fill out questionnaires 5 times for up to 18 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: FoRtitude 2.0Access to the study intervention website with interactive content, including information to read and videos to watch, and an optional text-messaging feature |
| Attentive Care | Other | Behavioral: Attention ControlAccess to the non-interactive study intervention website that lists links to help you access websites that provide information to read and resources for breast cancer survivors. |
| Usual Care | No intervention | –Usual care for fear of recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant must be ≥ 18 years of age.
- Participant must have had histologically confirmed Stage 0-III breast cancer at time of diagnosis.
- Participant must have completed primary treatment 1-10 years prior to Step 0 registration.
- NOTE: Current hormonal therapy is allowed. NOTE: Primary treatment can include chemotherapy and/or surgery and/or radiation therapy.
- Participant must be receiving their care (cancer treatment or survivorship care) from an oncology provider affiliated with the NCORP site and are expected to continue care at the site for the next 18 months.
Key exclusion criteria (1 listed)
- Participant must not have any psychiatric or cognitive conditions that may affect the participant's ability to accurately provide self-report data, per clinical discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoRtitude 2.0A website and an interactive text-messaging feature | Behavioural | Intervention |
| Attention ControlAccess to the non-interactive study intervention website that lists links to help you access websites that provide information to read and resources for breast cancer survivors. | Behavioural | Attentive Care |
Primary outcome
Fear of Cancer Recurrence Inventory (FCRI)
Time frame: From 1 month post-intervention to 3 months post-intervention
Fear of Cancer Recurrence Inventory (FCRI) modified total score 143 (without coping or reassurance subscale items) measured during the study period. A graphical exploration of the data will be performed by examining the distribution of FCRI score at each follow up timepoint, as well as the changes in FCRI between the baseline and follow up visits. 1-month post-intervention completion (3 months post-randomization) will be defined as the primary comparison. For the primary analysis we will compare the FCRI score of the FoRtitude arm to each of two control arms at 3 months using Welch's t-test. Two two-group Welch's t-tests will be used to compare the FCRI score of the FoRtitude arm to each of the two control arms at 12 weeks.
2 secondary outcomes
Difference in fear of recurrence based on race across all arms
Time frame: From enrollment to 3 months
Change in quality of life measures
Time frame: At all time points, including long term outcomes at 6, 12 and 18 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynne I Wagner, Ph.D. study chair
UNC Chapel Hill Gillings School of Global Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoRtitude 2.0 in people with Breast Cancer Survivor and Fear of Cancer Recurrence, run by Eastern Cooperative Oncology Group at 1 site in United States.
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 15 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynne I Wagner, Ph.D. ((919) 966-7392, lynne.wagner@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Cancer Recurrence Inventory (FCRI) (time frame: From 1 month post-intervention to 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.