A Targeted Electronic Health Approach to Reduce Fear of Recurrence in Breast Cancer Survivors (FoRtitude)

NCT ID: NCT07122492

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-09-01

Brief 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. 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.

Conditions

Breast Cancer Survivor; Fear of Cancer Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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 Type: EXPERIMENTAL

FoRtitude 2.0

Intervention Type: BEHAVIORAL

A website and an interactive text-messaging feature

Attentive Care

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 Type: OTHER

Attention Control

Intervention Type: BEHAVIORAL

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.

Usual Care

Usual care for fear of recurrence.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FoRtitude 2.0

A website and an interactive text-messaging feature

Intervention Type: BEHAVIORAL

Attention Control

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynne I Wagner, Ph.D.

Role: STUDY_CHAIR

UNC Chapel Hill Gillings School of Global Public Health

Locations

UNC Chapel Hill School of Medicine Public Health

Chapel Hill, North Carolina, United States

Countries

United States

Central Contacts

Lynne I Wagner, Ph.D.

Role: CONTACT

lynne.wagner@unc.edu

(919) 966-7392

Facility Contacts

Lynne I Wagner, Ph.D.

Role: primary

lynne.wagner@unc.edu

(919) 966-7392

Other Identifiers

EAQ181

Identifier Type: -

Identifier Source: org_study_id