Clinical trial NCT03384992: Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors
Official title: Targeted eHealth Intervention to Reduce Fear of Recurrence Among Breast Cancer Survivors: The FoRtitude Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Fear of Cancer
Keywords: Fear of Cancer Recurrence
ehealth interventions
PROMIS
FoR
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-12-28
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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)

Eligibility criteria: Inclusion Criteria:

* 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

  1. Greater than 1 year post treatment (for phase I interviews and usability testing)
  2. Between 1 and 10 years post-treatment (for Phase I field testing and Phase II)
* 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

  a. 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fear of Cancer Recurrence Inventory (FCRI) total score (minus Coping and Reassurance subscales)
timeFrame: Baseline to Week 8 change score
Secondary outcomes:
measure: Impact of Events Scale - Revised
timeFrame: Baseline to Week 8 change score
measure: Concerns about Recurrence Scale (CARS) - 4 item severity score
timeFrame: Baseline to Week 8 change score
measure: PROMIS Anxiety Computer adaptive test
timeFrame: Baseline to Week 8 change score
measure: PROMIS Depression Computer adaptive test
timeFrame: Baseline to Week 8 change score
measure: PROMIS Sleep Disturbance Computer adaptive test
timeFrame: Baseline to Week 8 change score
measure: PROMIS Fatigue Computer adaptive test
timeFrame: Baseline to Week 8 change score
measure: PROMIS Global Health
timeFrame: Baseline to Week 8 change score
measure: PROMIS Applied Cognition Computer adaptive test
timeFrame: Baseline to Week 8 change score
measure: Breast Cancer Self-Efficacy scale (BCSE)
timeFrame: Baseline to Week 8 change score
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Lynne Wagner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: