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

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 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.

Conditions

• Breast Cancer
• Fear of Cancer

Interventions

OTHER

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).

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

Usual care

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Lynne Wagner, Ph.D. · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2015-12-05

Completion

2015-12-05