FoRtitude for Cancer Anxiety

(FoRtitude Trial)

Overseen By Lynne I Wagner, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Eastern Cooperative Oncology Group

Disqualifiers: Psychiatric, Cognitive conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help breast cancer survivors reduce their fear of cancer recurrence. Participants will be divided into three groups: one will use an interactive online tool called FoRtitude 2.0, which includes information and text messaging; another will access a non-interactive website with helpful links; and the last group will follow usual care by speaking to their healthcare team. This trial is ideal for breast cancer survivors who completed their main treatment within the last 1-10 years and are currently receiving care from an NCORP-affiliated oncology provider. Participants must have internet access and be willing to answer questionnaires over 18 months. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in managing post-treatment anxiety.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow for continued use of hormonal therapy. It's best to discuss your specific medications with your healthcare provider.

What prior data suggests that the FoRtitude intervention is safe for breast cancer survivors?

Research has shown that the FoRtitude 2.0 program, an online tool for breast cancer survivors to manage their fear of cancer returning, received positive feedback in past studies. The tool includes a website with information and videos, and users can opt to receive supportive text messages. No major issues or side effects have been reported from using this online tool. It is designed to be safe and helpful, supporting users without causing harm. This suggests it should be a safe choice for those considering joining a trial with FoRtitude 2.0. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FoRtitude 2.0 for cancer anxiety because it offers a unique, interactive online platform designed specifically to help patients manage their fear of cancer recurrence. Unlike traditional therapy or medication, this platform provides engaging content, including videos and interactive text messaging, that can be accessed anytime, anywhere. This approach aims to empower patients with personalized support and resources, making it a flexible and convenient alternative to conventional treatments.

What evidence suggests that this trial's treatments could be effective for reducing fear of recurrence in breast cancer survivors?

Studies have shown that the FoRtitude 2.0 program, available to participants in this trial, can significantly reduce the fear of cancer recurrence in breast cancer survivors. One study found that participants using FoRtitude 2.0 experienced greater improvements in fear levels compared to those not using the program. Specifically, their scores decreased noticeably on a scale measuring concerns about cancer returning. The program employs techniques such as relaxation, altering negative thoughts, and practicing worry management to help reduce anxiety. Early findings suggest these strategies effectively lighten the mental load for cancer survivors. ^{1 2 4 6 7}

Who Is on the Research Team?

Lynne I Wagner, Ph.D.

Principal Investigator

UNC Chapel Hill Gillings School of Global Public Health

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who are experiencing anxiety about their cancer returning. Participants must be willing to answer questions about their fears, use web-based resources or discuss concerns with their oncology team.

Inclusion Criteria

Participant must be fluent in written and spoken English

Participant must complete the FCRI 9-item severity scale and report a score of 13 or higher

I currently have no active cancer, except for possible local skin cancer.

Exclusion Criteria

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to one of three options: an eHealth intervention with interactive content, a non-interactive website with general information, or usual care involving discussions with their oncology team.

3 months

5 visits (virtual)

Follow-up

Participants are monitored for changes in fear of recurrence and quality of life measures, with assessments at 6, 12, and 18 months.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• FoRtitude 2.0

Trial Overview The study tests if the FoRtitude eHealth intervention (a website and optional text messaging) or general survivorship information can reduce fear of recurrence in breast cancer survivors compared to standard care discussions with oncology teams.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Access to the study intervention website with interactive content, including information to read and videos to watch, and an optional text-messaging feature

Group II: Attentive Care Experimental Treatment 1 Intervention

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.

Group III: Usual Care Active Control 1 Intervention

Usual care for fear of recurrence.

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10980062

Randomized controlled trial of FoRtitude - NIH RePORTER Evaluate the efficacy of FoRtitude 2.0 to improve psychological and behavioral consequences of FoR, including anxiety, depression, HRQL, and health care ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07122492

A Targeted Electronic Health Approach to Reduce Fear of ... The main question it aims to answer are: Can the FoRtitude intervention lower the fear of recurrence for Breast Cancer Survivors? Participants ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8244801/

Targeted eHealth Intervention to Reduce Breast Cancer ... This study evaluated a targeted eHealth intervention, “FoRtitude,” to reduce FoR using cognitive behavioral skills training and telecoaching.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03384992

Targeted eHealth Intervention to Reduce Fear of ... The FoRtitude study will examine whether three coping strategies (relaxation training, cognitive restructuring, worry practice) are more effective than general ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.00699

Smartphone Psychotherapy Reduces Fear of Cancer ... The intervention group had statistically greater improvements than controls at week 8 on the Concerns About Recurrence Scale (difference –1.39; ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07122492?term=NA

A Targeted Electronic Health Approach to Reduce Fear of ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe ...

7. ascopubs.org ascopubs.org/doi/10.1200/EDBK_100031

Fear of Cancer Recurrence or Progression: What Is It and ... Risk Factors Associated With Fear of Cancer ... FoRtitude: an eHealth intervention to reduce fear of recurrence among breast cancer survivors.